Soft Tissue Sarcoma
Conditions
Brief summary
The investigators have recently demonstrated that argininosuccinate synthase 1 (ASS1) expression is silenced in 88% of all sarcomas (n=708), and that this loss is associated with a decreased overall survival. Using the extracellular arginine depleting enzyme PEGylated arginine deiminase (ADI-PEG20), an extracellular arginine depleting enzyme, the investigators demonstrated ADI-PEG20 induces a prosurvival metabolic reprogramming in ASS1-deficient sarcomas that redirects glucose into the serine/folate pathway directing the carbons from glucose into pyrimidine biosynthesis, thus sensitizing cells to death by the pyrimidine antimetabolite gemcitabine by using metabolomics. The synthetic lethality was increased by the addition of docetaxel. Therefore a phase II clinical trial of ADI with gemcitabine and docetaxel, a standard second line therapy for soft tissue sarcoma will be conducted to determine if the clinical benefit rate of gemcitabine and docetaxel is improved by the metabolic changes induced by ADI-PEG20. Recently published data shows that priming ASS1-deficient tumors with ADI-PEG 20 and docetaxel improves the effect of gemcitabine. Therefore, a cohort of patients consisting of ten patients diagnosed with either osteosarcoma or Ewing's sarcoma (ideally five of each), and five patients diagnosed with small cell lung cancer will be included as an exploratory cohort. Enrollment to Cohort 2 will occur concurrently with Cohort 1.
Interventions
DRUGpegylated arginine deiminase
-Arginine deiminase (ADI) is a recombinant protein cloned from M. hominis, produced in E. coli, and conjugated with PEG of 20,000 mw using a succinimidyl succinate linker. Thus ADI-PEG 20 is an arginine degrading enzyme, ADI, coupled to PEG.
DRUGGemcitabine
-Gemcitabine is a nucleoside metabolic inhibitor that exhibits antitumor activity.
DRUGDocetaxel
-Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants.
PROCEDURETumor biopsy
* Up to 21 days prior to initiation of ADI-PEG 20 Day -1 (+/- 1 day as long as performed prior to initiation of gemcitabine. * Tumor biopsies are mandatory for the first 20 patients amendable to biopsy enrolled at Washington University only (completed as of 05/14/2019) and for all patients enrolled to the SCLC cohort
PROCEDUREResearch blood draw
-Day -7 (pre-treatment), Day -1, and Days 1 and 8 of each cycle
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cohort 1: Histologically or cytologically confirmed grade 2 or 3 soft tissue sarcoma that is unresectable or metastatic that would be standardly treated with gemcitabine or gemcitabine and docetaxel. For all others, please contact the principal investigator. Prior surgery for primary or metastatic disease after chemotherapy following a response is allowed. * Cohort 2: Histologically or cytologically confirmed osteosarcoma, Ewing's sarcoma, or small cell lung cancer that is unresectable or metastatic that have either failed standard of care therapy or would be standardly treated with gemcitabine or gemcitabine and docetaxel. * Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam. * Treated with at least one line of systemic therapy. The allowable window between treatments is 21 days for chemotherapy or a TKI, or 5 ½ half-lives for a TKI (whichever is shorter), 21 days and progression by CT for immunotherapy, 21 days for RT, 21 days for surgery, or 28 days for an investigational agent. * Cohort 1: At least 16 years of age. * Cohort 2: Patients with osteosarcoma or Ewing's sarcoma must be at least 10 years of age. Patients with small cell lung cancer must be at least 18 years of age. * Cohort 2 (SCLC group ONLY): Must be amenable to biopsy * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Normal bone marrow and organ function as defined below: * Leukocytes ≥ 3,000/mcL * Absolute neutrophil count ≥ 1,500/mcl * Platelets ≥ 100,000/mcl * Total bilirubin ≤ 2 x institutional upper limit of normal (IULN) * AST(SGOT)/ALT(SGPT) ≤ 3 x IULN (or ≤ 5 x IULN if liver metastases are present) * Creatinine ≤ 1.5 x IULN OR * Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal * Serum uric acid ≤ 8 mg/dL (with or without medication control) * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion criteria
* A history of other high grade malignancy ≤ 5 years previous. Exceptions include basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix, or other tumors discussed with the study PI * Currently receiving any other investigational agents. * Prior treatment with ADI-PEG 20, gemcitabine, or docetaxel. Patients treated \> one year ago in the adjuvant/neoadjuvant setting with gemcitabine or docetaxel would be allowed to be enrolled on the trial. * Known brain metastases. Patients with known brain metastases must be excluded from this clinical trial (except for patients with SCLC, see below) because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with SCLC are allowed to enroll with brain metastases provided they are stable and they are at least 3 months post-treatment for brain metastases. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20, gemcitabine, pegylated compounds, or other agents used in the study. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * History of seizure disorder not related to underlying cancer. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. * Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with the study treatment. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) (Cohort 1 Only) | Through completion of follow-up (median follow-up 494 days, full range of 5-1500 days). | * PFS: defined as time on study to time patients progressed on the drug combination or death or latest follow-up if progression/death is not observed yet * Progressive disease: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) (Cohort 1 Only) | Through completion of follow-up (median follow-up 494 days, full range of 5-1500 days). | -OS: defined as time on study to time of death due to any reasons or latest follow-up (whichever is earlier) |
| Clinical Benefit Rate (CBR) (Cohort 1 Only) | Through completion of treatment (median treatment of 9 months) | * CBR = proportion of patients who have experienced complete response (CR)+ partial response (PR) + stable disease (SD) lasting 24 weeks or longer * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | From start of treatment through 30 days after completion of treatment (median treatment of 9 months + 1 month follow-up) | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting. |
| Number of Participants With Cancer-related Mortality (Cohort 1 Only) | Through completion of follow-up (median follow-up 494 days, full range of 5-1500 days). | — |
Countries
United States
Participant flow
Pre-assignment details
1 patient was enrolled, but never initiated treatment.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel Patients enrolling to Cohort 1 must be diagnosed with soft tissue sarcoma.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks) | 82 |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel Patients enrolling to Cohort 2 must be diagnosed with osteosarcoma, Ewing's sarcoma, or small cell lung cancer.
* ADI-PEG 20 will be given on Day -7 of Cycle 1 and then on Days 1, 8, and 15 of each subsequent cycle. Cycles are 21 days. ADI-PEG 20 will be given on an outpatient basis at a dose of 36 mg/m2 via intramuscular injection into either the deltoid or gluteal muscle.
* Gemcitabine will be given intravenously at a dose of 600 mg/m2 over 90 minutes on Days 1 and 8 of each cycle. Docetaxel will be given intravenously at a dose of 60 mg/m2 over 60 minutes on Day 8 of each cycle. Patients started on gemcitabine at a dose of 900 mg/m2 or 750 mg/m2 or docetaxel at a dose of 75 mg/m2 per previous protocol version will be allowed to continue at that dose level
* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) upon request.
* Treatment may continue for up to 34 cycles (103 weeks) | 15 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Death | 6 | 2 |
| Overall Study | Patient elected for surgical intervention | 1 | 0 |
| Overall Study | Patient off for other complicating disease | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Progression | 57 | 12 |
| Overall Study | Withdrawal by Subject | 12 | 1 |
Baseline characteristics
| Characteristic | Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Total | Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel |
|---|---|---|---|
| Age, Continuous | 57 years | 55 years | 30 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants | 91 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 7 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 71 Participants | 82 Participants | 11 Participants |
| Region of Enrollment United States | 82 participants | 97 participants | 15 participants |
| Sex: Female, Male Female | 45 Participants | 52 Participants | 7 Participants |
| Sex: Female, Male Male | 37 Participants | 45 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 19 / 33 | 15 / 25 | 19 / 24 | 12 / 15 |
| other Total, other adverse events | 33 / 33 | 25 / 25 | 24 / 24 | 15 / 15 |
| serious Total, serious adverse events | 14 / 33 | 8 / 25 | 13 / 24 | 5 / 15 |
Outcome results
Primary
Progression-free Survival (PFS) (Cohort 1 Only)
* PFS: defined as time on study to time patients progressed on the drug combination or death or latest follow-up if progression/death is not observed yet * Progressive disease: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Time frame: Through completion of follow-up (median follow-up 494 days, full range of 5-1500 days).
Population: PFS was evaluated only for Cohort 1; therefore, no participants in Cohort 2 were analyzed for this outcome measure. 2 participants in Cohort 1 were not evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Progression-free Survival (PFS) (Cohort 1 Only) | 5.0597 months |
Secondary
Clinical Benefit Rate (CBR) (Cohort 1 Only)
* CBR = proportion of patients who have experienced complete response (CR)+ partial response (PR) + stable disease (SD) lasting 24 weeks or longer * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: Through completion of treatment (median treatment of 9 months)
Population: CBR was evaluated only for Cohort 1; therefore, no participants in Cohort 2 were analyzed for this outcome measure. 8 participants in Cohort 1 were not evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Clinical Benefit Rate (CBR) (Cohort 1 Only) | 27 Participants |
Secondary
Number of Participants With Cancer-related Mortality (Cohort 1 Only)
Time frame: Through completion of follow-up (median follow-up 494 days, full range of 5-1500 days).
Population: Cancer-related mortality was evaluated only for Cohort 1; therefore, no participants in Cohort 2 were analyzed for this outcome measure. 7 participants in Cohort 1 were not evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Number of Participants With Cancer-related Mortality (Cohort 1 Only) | 47 Participants |
Secondary
Overall Survival (OS) (Cohort 1 Only)
-OS: defined as time on study to time of death due to any reasons or latest follow-up (whichever is earlier)
Time frame: Through completion of follow-up (median follow-up 494 days, full range of 5-1500 days).
Population: OS was evaluated only for Cohort 1; therefore, no participants in Cohort 2 were analyzed for this outcome measure. 7 participants in Cohort 1 were not evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Overall Survival (OS) (Cohort 1 Only) | 18.1359 months |
Secondary
Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.
Time frame: From start of treatment through 30 days after completion of treatment (median treatment of 9 months + 1 month follow-up)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 INR increased | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pruritus | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 retinal tear | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyponatremia | 14 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pruritus | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 minor gum transplant | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hot flashes | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 mitral valve disease | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperuricemia | 6 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypertension | 3 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypertension | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dry eye | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypernatremia | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypotension | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypotension | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypermagnesemia | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lymphedema | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypoxia | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 thromboembolic event | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 abdominal distension | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypermagnesemia | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 thromboembolic event | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 frozen thumb | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 colonic hemorrhage | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperlipidemia | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hip pain | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ankle sprain | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyperkalemia | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 port site bleed | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypoxia | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 colonic perforation | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 neutrophil count decreased | 6 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperkalemia | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 neutrophil count decreased | 19 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 chest pressure with exertion | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 platelet count decreased | 6 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyperglycemia | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vaginal cyst | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash NOS on neck | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anorexia | 5 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 constipation | 8 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperglycemia | 6 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 anorexia | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 leukemia secondary to oncology chemotherapy | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 atrial fibrillation | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypercalcemia | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hoarseness | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dehydration | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dental caries | 3 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 dehydration | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 dental caries | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sore throat | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 epistaxis | 6 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 diarrhea | 10 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 genital edema | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 diarrhea | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 atrial fibrillation | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 urinary tract obstruction | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dry mouth | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dyspepsia | 4 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 anemia | 19 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lower gastrointestinal hemorrhage | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 respiratory failure | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary retention | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lip pain | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 palpitations | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 mucositis oral | 6 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary frequency | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nausea | 13 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 renal calculi | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 oral pain | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rectal hemorrhage | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pericardial effusion | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hematuria | 9 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 small intestinal obstruction | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 acute kidney injury | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 typhlitis | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 wheezing | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 upper gastrointestinal hemorrhage | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 facial pain | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pneumonitis | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 insomnia | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fatigue | 16 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sinus bradycardia | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 fatigue | 7 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 depression | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fever | 5 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 flu-like symptoms | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 depression | 4 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 generalized edema | 5 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sinus tachycardia | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 infusion related reaction | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 presyncope | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 injection site reaction | 3 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 febrile neutropenia | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pleural effusion | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 Celiac disease | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 sinus tachycardia | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 extrapyramidal disorder | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bladder infection | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bronchial infection | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dysgeusia | 8 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 enterocolitis infectious | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 enterocolitis infectious | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 chest pain - cardiac | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dizziness | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 eye infection | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 folliculitis | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anemia | 11 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 concentration impairment | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 gum infection | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pleural effusion | 3 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail loss | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ear pain | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 tumor pain | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 palmar-plantar erythrodysesthesia syndrome | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 upper respiratory infection | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rhinorrhea | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tumor pain | 9 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 upper respiratory infection | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary tract infection | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vertigo | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 disease progression | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 urinary tract infection | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 wound infection | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nasal congestion | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin pailloma, R hallux | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ankle fracture | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperthyroidism | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 flank pain | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bruising | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fall | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 eosiniphilia | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bone pain | 3 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 fall | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fracture | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cataract | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 back pain | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 twisted knee | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 ileal bleed due to tumor invasion | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 back pain | 4 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 postoperative hemorrhage | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 laryngeal inflammation | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 spinal fracture | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 blurred vision | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 arthralgia | 3 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 wound complication | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 creatinine increased | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 electrocardiogram QT corrected interval prolonged | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypophosphatemia | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 electrocardiogram QT corrected interval prolonged | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 INR increased | 4 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 watering eyes | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypophosphatemia | 6 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 GGT increased | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyponatremia | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 ammonia increased | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 laryngeal hemorrhage | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin atrophy | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash NOS | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vomiting | 6 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 neck pain | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 petechial rash | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin ulceration | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anal mucositis | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 myalgia | 5 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urticaria | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 allergic rhinitis | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 muscle weakness lower limb | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 peripheral edema | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 vomiting | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 muscle tightness | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 muscle cramp | 6 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 left hand pain | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 right axillary pain | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 joint effusion | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lipase increased | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lipase increased | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 chills | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 generalized muscle weakness | 4 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lymphocyte count decreased | 6 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lymphocyte count decreased | 18 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 tinnitus | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 right neck stiffness | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vaginal hemorrhage | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 5 death NOS | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypokalemia | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash NOS on bilateral UE | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 platelet count decreased | 23 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 postnasal drip | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypokalemia | 5 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail bed pain | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 weight loss | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 edema face | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypoglycemia | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 white blood cell count decreased | 6 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ascites | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypoglycemia | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 white blood cell count decreased | 19 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 groin pain | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 feet peeling | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 acidosis | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 edema limbs | 9 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypocalcemia | 3 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyperuricemia | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypocalcemia | 12 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypoalbuminemia | 14 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypoalbuminemia | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 edema limbs | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pulmonary edema | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pelvic pain | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 edema trunk | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 edema trunk | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 localized edema | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 ascites | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 malaise | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary incontinence | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 non-cardiac chest pain | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 abdominal pain | 3 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 non-cardiac chest pain | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pneumothorax | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pain at injection site | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bloating | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 proteinuria | 7 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pain | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hepatic hemorrhage | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dysuria | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 allergic reaction | 3 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 allergic reaction | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 acute kidney injury | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 influenza A infection | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 colitis | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lung infection | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 irritability | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lung infection | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 papulopustular rash | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 alopecia | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pneumothorax | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dysphagia | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 confusion | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 paronychia | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bullous dermatitis | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 confusion | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pleural infection | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 sepsis | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fecal incontinence | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anxiety | 3 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sinusitis | 3 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin infection | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 abdominal pain | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 agitation | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 skin infection | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dry skin | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 dyspnea | 3 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tremor | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 thrush | 3 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 flatulence | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tooth infection | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 syncope | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperhidrosis | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail changes | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 gastroesophageal reflux disease | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 spinal cord compression | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail discoloration | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 activated partial thromboplastin time prolonged | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dyspnea | 12 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 phantom pain | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 activated partial thromboplastin time prolonged | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hematochezia | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 alanine aminotransferase increased | 12 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 peripheral sensory neuropathy | 9 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 alanine aminotransferase increased | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 productive cough | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 alkaline phosphatase increased | 12 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 paresthesia (face) | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 alkaline phosphatase increased | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 generalized GI bleed | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 aspartate aminotransferase increased | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 paresthesia | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 aspartate aminotransferase increased | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anal hemorrhage | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 blood bilirubin increased | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cough | 5 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 neuralgia | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 blood bilirubin increased | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tooth extraction | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lactate dehydrogenase increased | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 cerebral hemorrhage | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cardiac troponin I increased | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 cardiac troponin I increased | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 plantar sensitivity | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cardiac troponin T increased | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hemorrhoids | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 creatinine increased | 6 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 headache | 5 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash acneiform | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 bronchial obstruction | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 palpable lump RUE | 1 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash maculo-papular | 2 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 rash maculo-papular | 0 Participants |
| Cohort 1: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pain in extremity | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 cerebral hemorrhage | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 influenza A infection | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash maculo-papular | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 irritability | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 activated partial thromboplastin time prolonged | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin atrophy | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 allergic rhinitis | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 neck pain | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lung infection | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash NOS | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 colitis | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lactate dehydrogenase increased | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 peripheral sensory neuropathy | 5 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 petechial rash | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vomiting | 4 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 myalgia | 7 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lung infection | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin ulceration | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 tinnitus | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 confusion | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tooth extraction | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urticaria | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 alanine aminotransferase increased | 13 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 muscle weakness lower limb | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 alopecia | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 papulopustular rash | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 peripheral edema | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hematochezia | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 muscle cramp | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 abdominal distension | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 muscle tightness | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 vomiting | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 palpable lump RUE | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 alanine aminotransferase increased | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 left hand pain | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anal mucositis | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 joint effusion | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 paronychia | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dysphagia | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 confusion | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lipase increased | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vaginal hemorrhage | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 generalized muscle weakness | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cardiac troponin I increased | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lipase increased | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 paresthesia (face) | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anal hemorrhage | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pleural infection | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lymphocyte count decreased | 7 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 chills | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 right axillary pain | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 flank pain | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 productive cough | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lymphocyte count decreased | 11 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anxiety | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypokalemia | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 alkaline phosphatase increased | 11 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 right neck stiffness | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 sepsis | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bullous dermatitis | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 dyspnea | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 5 death NOS | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cough | 6 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypokalemia | 6 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 plantar sensitivity | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash NOS on bilateral UE | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 platelet count decreased | 18 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 upper gastrointestinal hemorrhage | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sinusitis | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 groin pain | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fecal incontinence | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypoglycemia | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail bed pain | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 agitation | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 weight loss | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 alkaline phosphatase increased | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin infection | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 cardiac troponin I increased | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 white blood cell count decreased | 5 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 edema face | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 paresthesia | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypoglycemia | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 bronchial obstruction | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tremor | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 white blood cell count decreased | 17 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 aspartate aminotransferase increased | 7 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypocalcemia | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 skin infection | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 generalized GI bleed | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 acidosis | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash acneiform | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pain in extremity | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypocalcemia | 6 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 thrush | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyperuricemia | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 edema limbs | 5 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 aspartate aminotransferase increased | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dry skin | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypoalbuminemia | 6 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ascites | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypoalbuminemia | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 syncope | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pelvic pain | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cardiac troponin T increased | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 edema limbs | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tooth infection | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 flatulence | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 abdominal pain | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 edema trunk | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pneumothorax | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 genital edema | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 neuralgia | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 urinary tract obstruction | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 postnasal drip | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 localized edema | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperhidrosis | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary incontinence | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dyspnea | 4 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 malaise | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 ascites | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 spinal cord compression | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 blood bilirubin increased | 6 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 non-cardiac chest pain | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail changes | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 renal calculi | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 headache | 5 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 non-cardiac chest pain | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 rash maculo-papular | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 proteinuria | 7 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 creatinine increased | 5 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pain at injection site | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail discoloration | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 gastroesophageal reflux disease | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 wound complication | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pain | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bloating | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dysuria | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pulmonary edema | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hepatic hemorrhage | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 abdominal pain | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 phantom pain | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 blood bilirubin increased | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 allergic reaction | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pneumothorax | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 acute kidney injury | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 activated partial thromboplastin time prolonged | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hemorrhoids | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 chest pressure with exertion | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 acute kidney injury | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 upper respiratory infection | 5 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 ammonia increased | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 edema trunk | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyponatremia | 7 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sore throat | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pruritus | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 insomnia | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 watering eyes | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 facial pain | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pruritus | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 twisted knee | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 minor gum transplant | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 retinal tear | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperuricemia | 5 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cataract | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hot flashes | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 upper respiratory infection | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fatigue | 15 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nasal congestion | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypertension | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypoxia | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypernatremia | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 depression | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypertension | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 disease progression | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 fatigue | 7 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sinus bradycardia | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypotension | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dry eye | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypermagnesemia | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 back pain | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypotension | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 mitral valve disease | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary tract infection | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fever | 9 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lymphedema | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rhinorrhea | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypermagnesemia | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 depression | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 thromboembolic event | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 electrocardiogram QT corrected interval prolonged | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 flu-like symptoms | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pleural effusion | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 thromboembolic event | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypoxia | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperlipidemia | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 ileal bleed due to tumor invasion | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 frozen thumb | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 eosiniphilia | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 generalized edema | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 urinary tract infection | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hip pain | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 colonic hemorrhage | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyperkalemia | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 presyncope | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ankle sprain | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 wheezing | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vertigo | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 infusion related reaction | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 port site bleed | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sinus tachycardia | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin pailloma, R hallux | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperkalemia | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anemia | 9 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 neutrophil count decreased | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 colonic perforation | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 injection site reaction | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 wound infection | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 neutrophil count decreased | 18 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 allergic reaction | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyperglycemia | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyponatremia | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 platelet count decreased | 5 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 extrapyramidal disorder | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 postoperative hemorrhage | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vaginal cyst | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hoarseness | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperglycemia | 4 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 Celiac disease | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash NOS on neck | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 INR increased | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anorexia | 5 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 feet peeling | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ankle fracture | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 constipation | 5 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 arthralgia | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypercalcemia | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bladder infection | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 anorexia | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 sinus tachycardia | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 leukemia secondary to oncology chemotherapy | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dysgeusia | 5 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 electrocardiogram QT corrected interval prolonged | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bronchial infection | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 dehydration | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 febrile neutropenia | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dehydration | 4 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 spinal fracture | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bruising | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dental caries | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 atrial fibrillation | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 epistaxis | 6 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 enterocolitis infectious | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 dental caries | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pleural effusion | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dizziness | 5 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperthyroidism | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 diarrhea | 7 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 respiratory failure | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 enterocolitis infectious | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bone pain | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 diarrhea | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 laryngeal hemorrhage | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fall | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 eye infection | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dry mouth | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 atrial fibrillation | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary retention | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 chest pain - cardiac | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dyspepsia | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 concentration impairment | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypophosphatemia | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lower gastrointestinal hemorrhage | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 folliculitis | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 GGT increased | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 INR increased | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lip pain | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 fall | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary frequency | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 gum infection | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 mucositis oral | 5 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 palpitations | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 laryngeal inflammation | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 tumor pain | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nausea | 8 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 anemia | 11 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 back pain | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail loss | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 oral pain | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pneumonitis | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hematuria | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 creatinine increased | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rectal hemorrhage | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fracture | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 blurred vision | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 palmar-plantar erythrodysesthesia syndrome | 1 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 small intestinal obstruction | 2 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pericardial effusion | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ear pain | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tumor pain | 3 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 typhlitis | 0 Participants |
| Cohort 2: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypophosphatemia | 3 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 typhlitis | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 wheezing | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anemia | 12 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 anemia | 12 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 febrile neutropenia | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 eosiniphilia | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 mitral valve disease | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 atrial fibrillation | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 atrial fibrillation | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 palpitations | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pericardial effusion | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sinus bradycardia | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sinus tachycardia | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 sinus tachycardia | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 chest pain - cardiac | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ear pain | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperthyroidism | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cataract | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 blurred vision | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 watering eyes | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 retinal tear | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dry eye | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 colonic hemorrhage | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 colonic perforation | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 constipation | 8 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dental caries | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 dental caries | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 diarrhea | 7 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 diarrhea | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dry mouth | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dyspepsia | 3 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lower gastrointestinal hemorrhage | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lip pain | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 mucositis oral | 3 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nausea | 14 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 oral pain | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rectal hemorrhage | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 small intestinal obstruction | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 edema trunk | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 facial pain | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fatigue | 10 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 fatigue | 8 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fever | 5 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 flu-like symptoms | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 generalized edema | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 infusion related reaction | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 injection site reaction | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 allergic reaction | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 Celiac disease | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bladder infection | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bronchial infection | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 enterocolitis infectious | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 enterocolitis infectious | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 eye infection | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 folliculitis | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 gum infection | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail loss | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 palmar-plantar erythrodysesthesia syndrome | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 upper respiratory infection | 4 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 upper respiratory infection | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary tract infection | 4 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 urinary tract infection | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 wound infection | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ankle fracture | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bruising | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fall | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 fall | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fracture | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 twisted knee | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 ileal bleed due to tumor invasion | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 postoperative hemorrhage | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 spinal fracture | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 creatinine increased | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 electrocardiogram QT corrected interval prolonged | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 electrocardiogram QT corrected interval prolonged | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 INR increased | 9 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 GGT increased | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 INR increased | 3 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 ammonia increased | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pruritus | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 minor gum transplant | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hot flashes | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypertension | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypertension | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypotension | 3 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypotension | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lymphedema | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 thromboembolic event | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 thromboembolic event | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 frozen thumb | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hip pain | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ankle sprain | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 port site bleed | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lymphocyte count decreased | 20 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 neutrophil count decreased | 6 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 neutrophil count decreased | 11 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vaginal cyst | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 feet peeling | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anorexia | 5 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 leukemia secondary to oncology chemotherapy | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 anorexia | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dehydration | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 dehydration | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypercalcemia | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperglycemia | 5 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyperglycemia | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperkalemia | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyperkalemia | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperlipidemia | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypermagnesemia | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypermagnesemia | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypernatremia | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperuricemia | 6 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypokalemia | 3 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyponatremia | 11 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyponatremia | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypophosphatemia | 4 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypophosphatemia | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 arthralgia | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 back pain | 4 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 back pain | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bone pain | 3 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 palpable lump RUE | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin pailloma, R hallux | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 disease progression | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tumor pain | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 tumor pain | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 concentration impairment | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dizziness | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dysgeusia | 8 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 extrapyramidal disorder | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 presyncope | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 depression | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 depression | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 insomnia | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 acute kidney injury | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 proteinuria | 7 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary retention | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 genital edema | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 epistaxis | 3 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hoarseness | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypoxia | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypoxia | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 laryngeal hemorrhage | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 laryngeal inflammation | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nasal congestion | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pleural effusion | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pleural effusion | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pulmonary edema | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 respiratory failure | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 chest pressure with exertion | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rhinorrhea | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sore throat | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail bed pain | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 tinnitus | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 abdominal distension | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 abdominal pain | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 abdominal pain | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anal hemorrhage | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anal mucositis | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ascites | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 ascites | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bloating | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 colitis | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dysphagia | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fecal incontinence | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 flatulence | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 gastroesophageal reflux disease | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hematochezia | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 generalized GI bleed | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tooth extraction | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hemorrhoids | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 upper gastrointestinal hemorrhage | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vomiting | 3 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 vomiting | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 chills | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 5 death NOS | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 edema face | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 edema limbs | 10 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 edema limbs | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 edema trunk | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 localized edema | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 malaise | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 non-cardiac chest pain | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 non-cardiac chest pain | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pain at injection site | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pain | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hepatic hemorrhage | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 allergic reaction | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 influenza A infection | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lung infection | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lung infection | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 alopecia | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 papulopustular rash | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 paronychia | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pleural infection | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 sepsis | 4 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bullous dermatitis | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sinusitis | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin infection | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 skin infection | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 thrush | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tooth infection | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dry skin | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperhidrosis | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail changes | 4 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail discoloration | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 wound complication | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 activated partial thromboplastin time prolonged | 3 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 activated partial thromboplastin time prolonged | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 alanine aminotransferase increased | 8 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 alanine aminotransferase increased | 3 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 alkaline phosphatase increased | 13 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 alkaline phosphatase increased | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 aspartate aminotransferase increased | 8 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 aspartate aminotransferase increased | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 blood bilirubin increased | 6 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 blood bilirubin increased | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lactate dehydrogenase increased | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cardiac troponin I increased | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 cardiac troponin I increased | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cardiac troponin T increased | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 creatinine increased | 9 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pruritus | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash acneiform | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash maculo-papular | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 rash maculo-papular | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin atrophy | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash NOS | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 petechial rash | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin ulceration | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urticaria | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 peripheral edema | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 muscle tightness | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 left hand pain | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lipase increased | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lipase increased | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lymphocyte count decreased | 4 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 right axillary pain | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 right neck stiffness | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash NOS on neck | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 platelet count decreased | 9 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash NOS on bilateral UE | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 platelet count decreased | 12 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 weight loss | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vertigo | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 white blood cell count decreased | 5 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 white blood cell count decreased | 15 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 acidosis | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyperuricemia | 4 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypoalbuminemia | 13 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypoalbuminemia | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypocalcemia | 11 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypocalcemia | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypoglycemia | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypoglycemia | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypokalemia | 7 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 flank pain | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 generalized muscle weakness | 4 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 joint effusion | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 muscle cramp | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 muscle weakness lower limb | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 myalgia | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 neck pain | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pain in extremity | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 headache | 3 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 plantar sensitivity | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 cerebral hemorrhage | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 neuralgia | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 paresthesia | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 paresthesia (face) | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 peripheral sensory neuropathy | 10 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 phantom pain | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 spinal cord compression | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 syncope | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tremor | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 agitation | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anxiety | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 confusion | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 confusion | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 irritability | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 acute kidney injury | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dysuria | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hematuria | 8 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 renal calculi | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary frequency | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary incontinence | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 urinary tract obstruction | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pelvic pain | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 groin pain | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vaginal hemorrhage | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 allergic rhinitis | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 bronchial obstruction | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cough | 5 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dyspnea | 6 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 dyspnea | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pneumonitis | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pneumothorax | 0 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pneumothorax | 2 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 postnasal drip | 1 Participants |
| Cohort 1, 900 mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 productive cough | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 upper gastrointestinal hemorrhage | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 neck pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 rash maculo-papular | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash maculo-papular | 4 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anal mucositis | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pain in extremity | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash acneiform | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pruritus | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 extrapyramidal disorder | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 creatinine increased | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cardiac troponin T increased | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 allergic rhinitis | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 headache | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 cardiac troponin I increased | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cardiac troponin I increased | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hemorrhoids | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 plantar sensitivity | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lactate dehydrogenase increased | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 blood bilirubin increased | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tooth extraction | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 cerebral hemorrhage | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 blood bilirubin increased | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 aspartate aminotransferase increased | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anal hemorrhage | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 neuralgia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 aspartate aminotransferase increased | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 alkaline phosphatase increased | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 bronchial obstruction | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 paresthesia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 alkaline phosphatase increased | 5 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 alanine aminotransferase increased | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 generalized GI bleed | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 paresthesia (face) | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 alanine aminotransferase increased | 4 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 activated partial thromboplastin time prolonged | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hematochezia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 peripheral sensory neuropathy | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 activated partial thromboplastin time prolonged | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 wound complication | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 abdominal distension | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail changes | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperhidrosis | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cough | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 spinal cord compression | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dry skin | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 thrush | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 gastroesophageal reflux disease | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 syncope | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 skin infection | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bullous dermatitis | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 flatulence | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tremor | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin infection | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sinusitis | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 postnasal drip | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 agitation | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 sepsis | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pleural infection | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dyspnea | 3 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anxiety | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 paronychia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 alopecia | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fecal incontinence | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 confusion | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 papulopustular rash | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lung infection | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dysphagia | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 confusion | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 insomnia | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lung infection | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 influenza A infection | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 abdominal pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 irritability | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 gum infection | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 allergic reaction | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 abdominal pain | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 acute kidney injury | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hepatic hemorrhage | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pain | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pneumonitis | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dyspepsia | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hematuria | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pain at injection site | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 non-cardiac chest pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 non-cardiac chest pain | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bloating | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vertigo | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary frequency | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 malaise | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 localized edema | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pneumothorax | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary incontinence | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 injection site reaction | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 ascites | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 edema trunk | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 edema limbs | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypoalbuminemia | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 edema limbs | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypoalbuminemia | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyperuricemia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperuricemia | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ascites | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypocalcemia | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 acidosis | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 white blood cell count decreased | 9 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pelvic pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypocalcemia | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 white blood cell count decreased | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail bed pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 edema face | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypoglycemia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 weight loss | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 platelet count decreased | 7 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 5 death NOS | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypoglycemia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash NOS on bilateral UE | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 platelet count decreased | 4 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 productive cough | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypokalemia | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash NOS on neck | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 right axillary pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lymphocyte count decreased | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 groin pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 flank pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lipase increased | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lipase increased | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 chills | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 generalized muscle weakness | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 ammonia increased | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 left hand pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 vomiting | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 joint effusion | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 muscle tightness | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 peripheral edema | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pneumothorax | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 muscle cramp | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 thromboembolic event | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urticaria | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vaginal hemorrhage | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 muscle weakness lower limb | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin ulceration | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 petechial rash | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vomiting | 4 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 myalgia | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rash NOS | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin atrophy | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 wheezing | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyponatremia | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 INR increased | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 electrocardiogram QT corrected interval prolonged | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 laryngeal hemorrhage | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypophosphatemia | 3 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 electrocardiogram QT corrected interval prolonged | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 creatinine increased | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 cataract | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypophosphatemia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 spinal fracture | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 postoperative hemorrhage | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperthyroidism | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 arthralgia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 ileal bleed due to tumor invasion | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 twisted knee | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 chest pressure with exertion | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 back pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fracture | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 fall | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 laryngeal inflammation | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 back pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fall | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bruising | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 tinnitus | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bone pain | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ankle fracture | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ear pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 palpable lump RUE | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 wound infection | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 urinary tract infection | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 febrile neutropenia | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 skin pailloma, R hallux | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary tract infection | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 upper respiratory infection | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nasal congestion | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 disease progression | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 upper respiratory infection | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tooth infection | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 chest pain - cardiac | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 tumor pain | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail loss | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nail discoloration | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 sinus tachycardia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 tumor pain | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 folliculitis | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 eye infection | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 anemia | 4 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 concentration impairment | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 enterocolitis infectious | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 enterocolitis infectious | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pleural effusion | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dizziness | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bronchial infection | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 bladder infection | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sinus tachycardia | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dysgeusia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 Celiac disease | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 allergic reaction | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sinus bradycardia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 phantom pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 infusion related reaction | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 generalized edema | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 sore throat | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 presyncope | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 flu-like symptoms | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fever | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pleural effusion | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 depression | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 fatigue | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 fatigue | 5 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pericardial effusion | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 depression | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 facial pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 edema trunk | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 palpitations | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 typhlitis | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rhinorrhea | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 acute kidney injury | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 small intestinal obstruction | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dysuria | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 rectal hemorrhage | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 oral pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 pulmonary edema | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 proteinuria | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 nausea | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 renal calculi | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 mucositis oral | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lip pain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lower gastrointestinal hemorrhage | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dry mouth | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 atrial fibrillation | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 urinary retention | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 diarrhea | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 urinary tract obstruction | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 diarrhea | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 atrial fibrillation | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 genital edema | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 dyspnea | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 dental caries | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dental caries | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anemia | 9 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 epistaxis | 3 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 constipation | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dehydration | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 anorexia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 colonic perforation | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 dehydration | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 leukemia secondary to oncology chemotherapy | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 anorexia | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 respiratory failure | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypercalcemia | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 feet peeling | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 vaginal cyst | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hoarseness | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperglycemia | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 port site bleed | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 neutrophil count decreased | 7 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 colonic hemorrhage | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyperglycemia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 neutrophil count decreased | 3 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 lymphocyte count decreased | 8 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 colitis | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperkalemia | 2 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 ankle sprain | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hip pain | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 mitral valve disease | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hyperkalemia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 frozen thumb | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 right neck stiffness | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypoxia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyperlipidemia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 thromboembolic event | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 lymphedema | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 dry eye | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypermagnesemia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypotension | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypotension | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 retinal tear | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypermagnesemia | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypertension | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypertension | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 eosiniphilia | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hypernatremia | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hot flashes | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 minor gum transplant | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypoxia | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 watering eyes | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 hypokalemia | 1 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 pruritus | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 palmar-plantar erythrodysesthesia syndrome | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 blurred vision | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 1-2 hyponatremia | 5 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 INR increased | 0 Participants |
| Cohort 2, 600mg/m2 Gemcitabine Dose Level: ADI-PEG 20 + Gemcitabine + Docetaxel | Safety and Tolerability of Regimen as Measured by Number and Grade of Adverse Events | Grade 3-5 GGT increased | 1 Participants |