Adenocarcinoma, Digestive System Disease, Digestive System Neoplasm, Endocrine Gland Neoplasms, Endocrine System Diseases, Neoplasm, Glandular, Neoplasms, Neoplasms Pancreatic, Pancreatic Diseases, Pancreatic Neoplasms
Conditions
Brief summary
The purpose of this study is to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with metastatic pancreatic cancer.
Detailed description
This was a two-part, single-institution, open-label, dose-escalation, phase 1/2 study to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan in patients with metastatic pancreatic cancer. Part 1 of the study was a Phase 1 3 + 3 dose escalation study designed to evaluate the maximally tolerated dose (MTD) and safety of increasing doses of nab-paclitaxel in combination with gemcitabine, capecitabine, cisplatin, and irinotecan. There were two cohorts of dose escalations. The two cohorts differed based on the treatment cycle length (28 days for Cohort 1 and 21 days for Cohort 2). Dose escalation started with Cohort 1. Enrollment for Cohort 2 dose level 1 began once dose level 2 of Cohort 1 was shown to be safe and did not exceed MTD. Part 2 was a Phase 2 expansion cohort study for the evaluation of efficacy once the MTD had been determined.
Interventions
DRUGNab-paclitaxel
IV over 30 minutes; Days 1 and 15
DRUGGemcitabine
IV over 30 minutes; Days 1 and 15
DRUGCapecitabine
PO twice daily (BID); Days 1-7, 15-21
DRUGCisplatin
IV over 60 minutes; Days 1 and 15
DRUGIrinotecan
IV over 30 minutes; Days 1 and 15
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
Inclusion criteria
* Have histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma. * Patients with the presence of at least one measurable lesion. * Male or non-pregnant and non-lactating female of age \>18 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Patients must have adequate organ and marrow function defined by study-specified laboratory tests. * Must use acceptable form of birth control while on study. * Ability to understand and willingness to sign a written informed consent document.
Exclusion criteria
* Patients who will be considered for surgery are ineligible. * Patient who have had any prior chemotherapy within 5 years of enrollment. * Patient who have had radiotherapy for pancreatic cancer. * Age ≥ 76 years * Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study. * Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study. * Patient who has known brain metastases. * Patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, capecitabine, cisplatin, or irinotecan. * Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patient who has serious medical risk factors involving any of the major organ systems. * Patient who has known history of infection with HIV, hepatitis B, or hepatitis C. * Pregnant or breast feeding. * Patient is unwilling or unable to comply with study procedures * Patient with clinically significant wound.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Capecitabine. | 28 days | Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use. Participants received Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle (Cohort 1) or Days 1-14 of a 21 day cycle (Cohort 2) |
| Maximum Tolerated Dose (MTD) of Gemcitabine. | 28 days | Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. Participants received Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2) |
| Maximum Tolerated Dose (MTD) of Nab-paclitaxel. | 28 days | Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. Participants received Nab-paclitaxel: 20, 40, 60, 80, 100,125 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2) |
| Progression-free Survival (PFS) Using RECIST 1.1 Criteria | 27 months | PFS is defined as the number of months from the date of first dose to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve. |
| Maximum Tolerated Dose (MTD) of Cisplatin. | 28 days | Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. Participants received Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2) |
| Maximum Tolerated Dose (MTD) of Irinotecan. | 28 days | Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. Participants received Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the Combination of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Patients With Untreated Metastatic PDA. | 27 months | Number of patients who received the MTD (Cohort 1, Dose Level 5) that experienced a limiting toxicity. Limiting toxicity was defined as a grade 3 or above treatment-related toxicity, with the following exceptions: 1. Grade 3 anemia that resolves to \< grade 2 within 7 days; 2. Grade 3 thrombocytopenia without clinically significant bleeding that resolves to \< grade 2 within 7 days; 3. Grade 3 or 4 neutropenia that resolves to \<grade 2 within 7 days; 4. Grade 3 or 4 leucopenia/lymphopenia; 5. Grade 3 nausea, vomiting, or diarrhea that resolves to \<grade 2 within 72 hours; 6. Grade 3 or 4 asymptomatic laboratory values that resolve to \< grade 2 within 7 days; 7. Grade 3 dermatologic AEs that are considered mild in severity but only considered grade 3 because of \>30% body surface involvement; 8. Grade 3 fatigue lasting less than 72 hours. This study used the descriptions and grading scales found in the revised NCI CTCAE fV 5.0 for adverse event reporting. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phase 1, Cohort 1, Dose Level 1 Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 40 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle | 3 |
| Phase 1, Cohort 1, Dose Level 2 Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 60 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle | 6 |
| Phase 1, Cohort 1, Dose Level 3 Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 80 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle | 6 |
| Phase 1, Cohort 1, Dose Level 4 Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 100 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle | 6 |
| Phase 1, Cohort 1, Dose Level 5 Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 125 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle | 6 |
| Phase 1, Cohort 2, Dose Level 1 Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:40 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle | 3 |
| Phase 1, Cohort 2, Dose Level 2 Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:60 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle | 3 |
| Phase 1, Cohort 2, Dose Level 3 Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:80 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle | 7 |
| Phase 2, MTD Dose Expansion Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 125 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle | 8 |
| Total | 48 |
Baseline characteristics
| Characteristic | Phase 1, Cohort 1, Dose Level 2 | Total | Phase 2, MTD Dose Expansion | Phase 1, Cohort 2, Dose Level 3 | Phase 1, Cohort 2, Dose Level 2 | Phase 1, Cohort 2, Dose Level 1 | Phase 1, Cohort 1, Dose Level 1 | Phase 1, Cohort 1, Dose Level 5 | Phase 1, Cohort 1, Dose Level 4 | Phase 1, Cohort 1, Dose Level 3 |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 21 Participants | 4 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 27 Participants | 4 Participants | 7 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 5 Participants | 2 Participants |
| Eastern Cooperative Oncology Group (ECOG) ECOG 0 | 1 Participants | 6 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) ECOG 1 | 5 Participants | 42 Participants | 7 Participants | 5 Participants | 3 Participants | 2 Participants | 3 Participants | 6 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 48 Participants | 8 Participants | 7 Participants | 3 Participants | 3 Participants | 3 Participants | 6 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 6 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 40 Participants | 6 Participants | 6 Participants | 2 Participants | 2 Participants | 3 Participants | 6 Participants | 4 Participants | 5 Participants |
| Region of Enrollment United States | 6 Participants | 48 Participants | 8 Participants | 7 Participants | 3 Participants | 3 Participants | 3 Participants | 6 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Female | 4 Participants | 25 Participants | 5 Participants | 4 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 23 Participants | 3 Participants | 3 Participants | 3 Participants | 1 Participants | 1 Participants | 4 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 3 | 6 / 6 | 5 / 6 | 6 / 6 | 6 / 6 | 3 / 3 | 3 / 3 | 7 / 7 | 7 / 8 |
| other Total, other adverse events | 3 / 3 | 6 / 6 | 6 / 6 | 6 / 6 | 6 / 6 | 3 / 3 | 3 / 3 | 7 / 7 | 8 / 8 |
| serious Total, serious adverse events | 0 / 3 | 2 / 6 | 5 / 6 | 2 / 6 | 4 / 6 | 1 / 3 | 2 / 3 | 2 / 7 | 4 / 8 |
Outcome results
Primary
Maximum Tolerated Dose (MTD) of Capecitabine.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use. Participants received Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle (Cohort 1) or Days 1-14 of a 21 day cycle (Cohort 2)
Time frame: 28 days
Population: Cohort 1 cycle schedule was selected for the MTD (Days 1-7 and 15-21 of a 28 day cycle)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I | Maximum Tolerated Dose (MTD) of Capecitabine. | 500 mg BID |
Primary
Maximum Tolerated Dose (MTD) of Cisplatin.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. Participants received Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Time frame: 28 days
Population: Cohort 1 cycle schedule was selected for the MTD (Days 1 and 15 of a 28 day cycle)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I | Maximum Tolerated Dose (MTD) of Cisplatin. | 20 mg/m^2 |
Primary
Maximum Tolerated Dose (MTD) of Gemcitabine.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. Participants received Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Time frame: 28 days
Population: Cohort 1 cycle schedule was selected for the MTD (Days 1 and 15 of a 28 day cycle)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I | Maximum Tolerated Dose (MTD) of Gemcitabine. | 500 mg/m^2 |
Primary
Maximum Tolerated Dose (MTD) of Irinotecan.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. Participants received Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Time frame: 28 days
Population: Cohort 1 cycle schedule was selected for the MTD (Days 1 and 15 of a 28 day cycle)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I | Maximum Tolerated Dose (MTD) of Irinotecan. | 20 mg/m^2 |
Primary
Maximum Tolerated Dose (MTD) of Nab-paclitaxel.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. Participants received Nab-paclitaxel: 20, 40, 60, 80, 100,125 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Time frame: 28 days
Population: Cohort 1 cycle schedule was selected for the MTD (Days 1 and 15 of a 28 day cycle)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I | Maximum Tolerated Dose (MTD) of Nab-paclitaxel. | 125 mg/m^2 |
Primary
Progression-free Survival (PFS) Using RECIST 1.1 Criteria
PFS is defined as the number of months from the date of first dose to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Time frame: 27 months
Population: Per the clinical trial design, PFS analyses included all subjects who received the MTD (Cohort 1, Dose Level 5). Since the enrollment criteria and dose are the same, combining those who are treated at MTD at both phases increase the power and enable to estimate the treatment effect with increased precision. This included the 6 subjects enrolled in the Phase 1 portion of the trial and the 8 subjects enrolled in the Phase 2 portion of the trial for a total of 14 subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I | Progression-free Survival (PFS) Using RECIST 1.1 Criteria | 5.92 months |
Secondary
Safety of the Combination of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Patients With Untreated Metastatic PDA.
Number of patients who received the MTD (Cohort 1, Dose Level 5) that experienced a limiting toxicity. Limiting toxicity was defined as a grade 3 or above treatment-related toxicity, with the following exceptions: 1. Grade 3 anemia that resolves to \< grade 2 within 7 days; 2. Grade 3 thrombocytopenia without clinically significant bleeding that resolves to \< grade 2 within 7 days; 3. Grade 3 or 4 neutropenia that resolves to \<grade 2 within 7 days; 4. Grade 3 or 4 leucopenia/lymphopenia; 5. Grade 3 nausea, vomiting, or diarrhea that resolves to \<grade 2 within 72 hours; 6. Grade 3 or 4 asymptomatic laboratory values that resolve to \< grade 2 within 7 days; 7. Grade 3 dermatologic AEs that are considered mild in severity but only considered grade 3 because of \>30% body surface involvement; 8. Grade 3 fatigue lasting less than 72 hours. This study used the descriptions and grading scales found in the revised NCI CTCAE fV 5.0 for adverse event reporting.
Time frame: 27 months
Population: Per the clinical trial design, safety analyses included all subjects who received the MTD (Cohort 1, Dose Level 5). Since the enrollment criteria and dose are the same, combining those who are treated at MTD at both phases enable to estimate the toxicity rate with increased precision. This included the 6 subjects enrolled in the Phase 1 portion of the trial and the 8 subjects enrolled in the Phase 2 portion of the trial for a total of 14 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase I | Safety of the Combination of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Patients With Untreated Metastatic PDA. | 3 Participants |