Locally Advanced Pancreatic Adenocarcinoma
Conditions
Keywords
pancreatic neoplasms, digestive system neoplasms, pancreatic diseases, digestive system diseases, pancreatic adenocarcinoma, pancreatic cancer
Brief summary
Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally advanced pancreatic adenocarcinoma via direct intratumoral injection.
Detailed description
In this open-label, dose-escalating, Phase IIa trial, subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection. Subjects will be enrolled in sequential cohorts of NanoPac® at escalating doses, at a volume based on up to 20% of calculated tumor volume (with a maximum injection volume of 5 mL per subject). During the first phase of the trial (dose escalation), each cohort will have three subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data, the next cohort may begin enrolling, an additional three subjects at the current dose may be enrolled, or if the first dose does not provide adequate safety and tolerability the study may be halted. The dose determined to be most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile as determined by the Data Safety Monitoring Board (DSMB), will be the dose used in the second phase of the study which will enroll 22 additional subjects who will receive two injections of NanoPac® at the same dose one month apart. In the third phase of the study, up to 30 subjects will receive up to four injections of NanoPac at the same dose, one month apart. Plasma samples will be taken at various time points on the day of NanoPac® injection as well as once at each of the study visits, to characterize the pharmacokinetics (PK) of ITU NanoPac®. Subjects will be followed for 12 months after NanoPac® injection for safety, overall survival (OS), progression-free survival (PFS), CA-19-9 levels, carcinoembryonic antigen (CEA) levels, reduction in pain, and tumor response to therapy (as shown by imaging).
Interventions
DRUGNanoPac®
Subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.
Sponsors
US Biotest, Inc.
NanOlogy, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, dose-escalating, Phase IIa trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent; * Age ≥18 years; * Histologically/cytologically confirmed locally advanced pancreatic adenocarcinoma; at least one lesion with a diameter of at least 1.5 cm but no more than 6 cm as documented via imaging (within 6 weeks of Screening); * Subject not a candidate for surgery; * Completion of at least one standard of care IV chemotherapy course for subjects in the dose escalation phase of the study. IV chemotherapy will be initiated prior to first NanoPac injection for subjects in the second and third phases. Hematologic recovery must be confirmed prior to study entry; * Performance Status (ECOG) 0-1 at study entry; * Life expectancy of at least 3 months; * Adequate marrow, liver, and renal function at study entry: * ANC ≥ 1.5 x 109/L * Hemoglobin ≥ 9.5 grams/dL * Platelets ≥ 75 x 109/L * Total bilirubin ≤ 1.5x institutional ULN * AST/ ALT ≤ 2.5x institutional ULN * Creatinine ≤ 1.5x institutional ULN * Effective contraception if the risk of conception exists.
Exclusion criteria
* Thrombotic or embolic events; * Acute or subacute intestinal occlusion; * History of inflammatory bowel disease; * Known hypersensitivity to study drugs; * Known drug or alcohol abuse; * Pregnant or breastfeeding women; * Previous or concurrent history of non-pancreatic malignancy except for non-melanoma skin cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) | Up to Week 24 for Dose Escalation subjects; up to Week 28 for Second Phase subjects; up to 9 Months for Third Phase subjects. | Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Tumor Assessment | Week 24 | Response was determined using RECIST 1.1 parameters (complete response, partial response, stable disease, progressive disease, unevaluable) for the treated lesion in all groups. |
| Plasma Paclitaxel Concentration (pg/mL) | Day 1 and Week 24 | Plasma paclitaxel concentrations were analyzed in the dose escalation phase on Day 1 prior to injection and at 1, 2, 4, 6, and 24 hours after NanoPac injection, as well as at all other study visits. In the second and third phases, plasma paclitaxel concentrations were analyzed on Day 1 prior to NanoPac injection, and at 1 and 2 hours post NanoPac injection on all injection occasions, and at all study visits. |
| Pain (Visual Analog Scale) Score | Day 1 (pre-injection) and Week 24 | The visual analog scale (VAS) ranks pain from numbers 0 (no pain) to 10 (most pain). Lower scores mean a better outcome. |
| Serum CA19-9 Level | Day 1 (Pre-Injection) and Week 24 | CA19-9 is a tumor marker for pancreatic cancer. Serum CA19-9 levels were assessed at all study visits. |
| Serum CEA Levels | Day 1 (Pre-Injection) and Week 24 | Carcinoembryonic antigen (CEA) is a tumor marker for pancreatic cancer. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dose Escalation: NanoPac® 6 mg/mL Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. | 3 |
| Dose Escalation: NanoPac® 10 mg/mL Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. | 3 |
| Dose Escalation: NanoPac® 15 mg/mL Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. | 4 |
| Second Phase: NanoPac® 15 mg/mL Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection. | 25 |
| Third Phase: NanoPac® 15 mg/mL Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart. | 19 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 | 1 | 3 |
| Overall Study | Disease Progression | 1 | 0 | 0 | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 | 3 |
| Overall Study | Subject entered hospice care | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 2 | 1 |
| Overall Study | Withdrawn to proceed to surgery | 0 | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Third Phase: NanoPac® 15 mg/mL | Total | Second Phase: NanoPac® 15 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 6 mg/mL |
|---|---|---|---|---|---|---|
| Age, Continuous | 71.3 years STANDARD_DEVIATION 11.19 | 68.3 years STANDARD_DEVIATION 10.74 | 65.6 years STANDARD_DEVIATION 10.08 | 72.0 years STANDARD_DEVIATION 9.56 | 71.3 years STANDARD_DEVIATION 8.08 | 64.0 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 7 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 47 Participants | 25 Participants | 3 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 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 |
| Race (NIH/OMB) Asian | 0 Participants | 6 Participants | 4 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 46 Participants | 20 Participants | 3 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 19 participants | 54 participants | 25 participants | 4 participants | 3 participants | 3 participants |
| Sex: Female, Male Female | 10 Participants | 22 Participants | 11 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 9 Participants | 32 Participants | 14 Participants | 4 Participants | 3 Participants | 2 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 1 / 4 | 1 / 25 | 3 / 19 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 4 / 4 | 23 / 25 | 19 / 19 |
| serious Total, serious adverse events | 1 / 3 | 2 / 3 | 3 / 4 | 13 / 25 | 8 / 19 |
Outcome results
Primary
Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability)
Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.
Time frame: Up to Week 24 for Dose Escalation subjects; up to Week 28 for Second Phase subjects; up to 9 Months for Third Phase subjects.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation: NanoPac® 6 mg/mL | Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) | Number of subjects with at least one TEAE | 3 Participants |
| Dose Escalation: NanoPac® 6 mg/mL | Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) | Number of subjects without any TEAE | 0 Participants |
| Dose Escalation: NanoPac® 10 mg/mL | Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) | Number of subjects without any TEAE | 0 Participants |
| Dose Escalation: NanoPac® 10 mg/mL | Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) | Number of subjects with at least one TEAE | 3 Participants |
| Dose Escalation: NanoPac® 15 mg/mL | Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) | Number of subjects without any TEAE | 0 Participants |
| Dose Escalation: NanoPac® 15 mg/mL | Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) | Number of subjects with at least one TEAE | 4 Participants |
| Second Phase: NanoPac® 15 mg/mL | Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) | Number of subjects with at least one TEAE | 23 Participants |
| Second Phase: NanoPac® 15 mg/mL | Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) | Number of subjects without any TEAE | 2 Participants |
| Third Phase: NanoPac® 15 mg/mL | Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) | Number of subjects without any TEAE | 0 Participants |
| Third Phase: NanoPac® 15 mg/mL | Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) | Number of subjects with at least one TEAE | 19 Participants |
Secondary
Pain (Visual Analog Scale) Score
The visual analog scale (VAS) ranks pain from numbers 0 (no pain) to 10 (most pain). Lower scores mean a better outcome.
Time frame: Day 1 (pre-injection) and Week 24
Population: Pain measured with VAS was not available for all subjects at all timepoints. For the Day 1 Pre-Injection timepoint, there was one subject in the 6 mg/mL dose escalation group for whom VAS was not available. For the Week 24 timepoint, there was one subject in the 6 mg/mL dose escalation group, three in the 15 mg/mL dose escalation group, 12 in the second phase, and 9 in the third phase for whom VAS data was not available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: NanoPac® 6 mg/mL | Pain (Visual Analog Scale) Score | Week 24 | 5.3 units on a scale | Standard Deviation 3.18 |
| Dose Escalation: NanoPac® 6 mg/mL | Pain (Visual Analog Scale) Score | Day 1 (Pre-Injection) | 0 units on a scale | Standard Deviation 0 |
| Dose Escalation: NanoPac® 10 mg/mL | Pain (Visual Analog Scale) Score | Day 1 (Pre-Injection) | 0 units on a scale | Standard Deviation 0 |
| Dose Escalation: NanoPac® 10 mg/mL | Pain (Visual Analog Scale) Score | Week 24 | 0.8 units on a scale | Standard Deviation 1.44 |
| Dose Escalation: NanoPac® 15 mg/mL | Pain (Visual Analog Scale) Score | Day 1 (Pre-Injection) | 5.5 units on a scale | Standard Deviation 4.12 |
| Dose Escalation: NanoPac® 15 mg/mL | Pain (Visual Analog Scale) Score | Week 24 | 5.0 units on a scale | — |
| Second Phase: NanoPac® 15 mg/mL | Pain (Visual Analog Scale) Score | Day 1 (Pre-Injection) | 1.2 units on a scale | Standard Deviation 2.41 |
| Second Phase: NanoPac® 15 mg/mL | Pain (Visual Analog Scale) Score | Week 24 | 1.7 units on a scale | Standard Deviation 2.53 |
| Third Phase: NanoPac® 15 mg/mL | Pain (Visual Analog Scale) Score | Week 24 | 1.1 units on a scale | Standard Deviation 2.23 |
| Third Phase: NanoPac® 15 mg/mL | Pain (Visual Analog Scale) Score | Day 1 (Pre-Injection) | 0.8 units on a scale | Standard Deviation 1.42 |
Secondary
Plasma Paclitaxel Concentration (pg/mL)
Plasma paclitaxel concentrations were analyzed in the dose escalation phase on Day 1 prior to injection and at 1, 2, 4, 6, and 24 hours after NanoPac injection, as well as at all other study visits. In the second and third phases, plasma paclitaxel concentrations were analyzed on Day 1 prior to NanoPac injection, and at 1 and 2 hours post NanoPac injection on all injection occasions, and at all study visits.
Time frame: Day 1 and Week 24
Population: Not all subjects had data at all timepoints. On Day 1, data available for one subject in dose escalation 6 mg/mL, none in 10 mg/mL, and one in 15 mg/mL; second phase, six subjects; third phase three subjects. At Week 24, data available for one subject in dose escalation 6 mg/mL, none in 10 mg/mL, none in 15 mg/mL; second phase, eight subjects; third phase five subjects. Forty subjects received concomitant IV chemotherapy while on study; of these, 14 received concomitant taxane therapy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: NanoPac® 6 mg/mL | Plasma Paclitaxel Concentration (pg/mL) | Day 1 Pre-Injection | 62.1 pg/mL | — |
| Dose Escalation: NanoPac® 6 mg/mL | Plasma Paclitaxel Concentration (pg/mL) | Week 24 | 30 pg/mL | — |
| Dose Escalation: NanoPac® 15 mg/mL | Plasma Paclitaxel Concentration (pg/mL) | Day 1 Pre-Injection | 304 pg/mL | — |
| Second Phase: NanoPac® 15 mg/mL | Plasma Paclitaxel Concentration (pg/mL) | Week 24 | 5017.8 pg/mL | Standard Deviation 12139.23 |
| Second Phase: NanoPac® 15 mg/mL | Plasma Paclitaxel Concentration (pg/mL) | Day 1 Pre-Injection | 5497.0 pg/mL | Standard Deviation 11887.04 |
| Third Phase: NanoPac® 15 mg/mL | Plasma Paclitaxel Concentration (pg/mL) | Day 1 Pre-Injection | 17347.7 pg/mL | Standard Deviation 27686.44 |
| Third Phase: NanoPac® 15 mg/mL | Plasma Paclitaxel Concentration (pg/mL) | Week 24 | 63.2 pg/mL | Standard Deviation 60.16 |
Secondary
Serum CA19-9 Level
CA19-9 is a tumor marker for pancreatic cancer. Serum CA19-9 levels were assessed at all study visits.
Time frame: Day 1 (Pre-Injection) and Week 24
Population: Missing CA19-9 data for Day 1: dose escalation 6 mg/mL two subjects; second phase two subjects; third phase three subjects. Missing CA19-9 data for Week 24: dose escalation 6 mg/mL one subject; dose escalation 15 mg/mL two subjects; second phase 10 subjects; third phase nine subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: NanoPac® 6 mg/mL | Serum CA19-9 Level | Week 24 | 5476 U/mL | Standard Deviation 6396.49 |
| Dose Escalation: NanoPac® 6 mg/mL | Serum CA19-9 Level | Day 1 - Pre-Injection | 248 U/mL | — |
| Dose Escalation: NanoPac® 10 mg/mL | Serum CA19-9 Level | Week 24 | 49.3 U/mL | Standard Deviation 60.3 |
| Dose Escalation: NanoPac® 10 mg/mL | Serum CA19-9 Level | Day 1 - Pre-Injection | 24 U/mL | Standard Deviation 24 |
| Dose Escalation: NanoPac® 15 mg/mL | Serum CA19-9 Level | Day 1 - Pre-Injection | 2958 U/mL | Standard Deviation 4749 |
| Dose Escalation: NanoPac® 15 mg/mL | Serum CA19-9 Level | Week 24 | 6179 U/mL | Standard Deviation 5402.3 |
| Second Phase: NanoPac® 15 mg/mL | Serum CA19-9 Level | Day 1 - Pre-Injection | 952 U/mL | Standard Deviation 2171 |
| Second Phase: NanoPac® 15 mg/mL | Serum CA19-9 Level | Week 24 | 141.6 U/mL | Standard Deviation 184.03 |
| Third Phase: NanoPac® 15 mg/mL | Serum CA19-9 Level | Week 24 | 1222.6 U/mL | Standard Deviation 3126 |
| Third Phase: NanoPac® 15 mg/mL | Serum CA19-9 Level | Day 1 - Pre-Injection | 198 U/mL | Standard Deviation 362 |
Secondary
Serum CEA Levels
Carcinoembryonic antigen (CEA) is a tumor marker for pancreatic cancer.
Time frame: Day 1 (Pre-Injection) and Week 24
Population: Missing CEA data for Day 1: dose escalation 6 mg/mL one subject; second phase two subjects; third phase two subjects. Missing CEA data for Week 24: dose escalation 6 mg/mL one subject; dose escalation 15 mg/mL three subjects; second phase 11 subjects; third phase nine subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: NanoPac® 6 mg/mL | Serum CEA Levels | Week 24 | 4.55 ug/L | Standard Deviation 2.758 |
| Dose Escalation: NanoPac® 6 mg/mL | Serum CEA Levels | Day 1 - Pre-Injection | 1.65 ug/L | Standard Deviation 0.778 |
| Dose Escalation: NanoPac® 10 mg/mL | Serum CEA Levels | Week 24 | 53.33 ug/L | Standard Deviation 84.577 |
| Dose Escalation: NanoPac® 10 mg/mL | Serum CEA Levels | Day 1 - Pre-Injection | 27.1 ug/L | Standard Deviation 41.57 |
| Dose Escalation: NanoPac® 15 mg/mL | Serum CEA Levels | Day 1 - Pre-Injection | 4.58 ug/L | Standard Deviation 1.68 |
| Dose Escalation: NanoPac® 15 mg/mL | Serum CEA Levels | Week 24 | 10.3 ug/L | — |
| Second Phase: NanoPac® 15 mg/mL | Serum CEA Levels | Day 1 - Pre-Injection | 5.17 ug/L | Standard Deviation 3.163 |
| Second Phase: NanoPac® 15 mg/mL | Serum CEA Levels | Week 24 | 5.49 ug/L | Standard Deviation 3.291 |
| Third Phase: NanoPac® 15 mg/mL | Serum CEA Levels | Day 1 - Pre-Injection | 6.69 ug/L | Standard Deviation 5.976 |
| Third Phase: NanoPac® 15 mg/mL | Serum CEA Levels | Week 24 | 13.04 ug/L | Standard Deviation 16.718 |
Secondary
Target Tumor Assessment
Response was determined using RECIST 1.1 parameters (complete response, partial response, stable disease, progressive disease, unevaluable) for the treated lesion in all groups.
Time frame: Week 24
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation: NanoPac® 6 mg/mL | Target Tumor Assessment | Progressive Disease | 1 Participants |
| Dose Escalation: NanoPac® 6 mg/mL | Target Tumor Assessment | Complete Response | 0 Participants |
| Dose Escalation: NanoPac® 6 mg/mL | Target Tumor Assessment | Not evaluable | 1 Participants |
| Dose Escalation: NanoPac® 6 mg/mL | Target Tumor Assessment | Partial Response | 0 Participants |
| Dose Escalation: NanoPac® 6 mg/mL | Target Tumor Assessment | Stable Disease | 1 Participants |
| Dose Escalation: NanoPac® 10 mg/mL | Target Tumor Assessment | Progressive Disease | 2 Participants |
| Dose Escalation: NanoPac® 10 mg/mL | Target Tumor Assessment | Stable Disease | 0 Participants |
| Dose Escalation: NanoPac® 10 mg/mL | Target Tumor Assessment | Not evaluable | 0 Participants |
| Dose Escalation: NanoPac® 10 mg/mL | Target Tumor Assessment | Partial Response | 1 Participants |
| Dose Escalation: NanoPac® 10 mg/mL | Target Tumor Assessment | Complete Response | 0 Participants |
| Dose Escalation: NanoPac® 15 mg/mL | Target Tumor Assessment | Stable Disease | 1 Participants |
| Dose Escalation: NanoPac® 15 mg/mL | Target Tumor Assessment | Partial Response | 0 Participants |
| Dose Escalation: NanoPac® 15 mg/mL | Target Tumor Assessment | Complete Response | 0 Participants |
| Dose Escalation: NanoPac® 15 mg/mL | Target Tumor Assessment | Progressive Disease | 0 Participants |
| Dose Escalation: NanoPac® 15 mg/mL | Target Tumor Assessment | Not evaluable | 3 Participants |
| Second Phase: NanoPac® 15 mg/mL | Target Tumor Assessment | Complete Response | 0 Participants |
| Second Phase: NanoPac® 15 mg/mL | Target Tumor Assessment | Progressive Disease | 1 Participants |
| Second Phase: NanoPac® 15 mg/mL | Target Tumor Assessment | Not evaluable | 10 Participants |
| Second Phase: NanoPac® 15 mg/mL | Target Tumor Assessment | Stable Disease | 12 Participants |
| Second Phase: NanoPac® 15 mg/mL | Target Tumor Assessment | Partial Response | 2 Participants |
| Third Phase: NanoPac® 15 mg/mL | Target Tumor Assessment | Stable Disease | 2 Participants |
| Third Phase: NanoPac® 15 mg/mL | Target Tumor Assessment | Not evaluable | 9 Participants |
| Third Phase: NanoPac® 15 mg/mL | Target Tumor Assessment | Progressive Disease | 5 Participants |
| Third Phase: NanoPac® 15 mg/mL | Target Tumor Assessment | Complete Response | 0 Participants |
| Third Phase: NanoPac® 15 mg/mL | Target Tumor Assessment | Partial Response | 3 Participants |