Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally advanced pancreatic adenocarcinoma via direct intratumoral injection.
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.
Cedars-Sinai Medical Center
Los Angeles, California, United States
Parkview Cancer Institute
Fort Wayne, Indiana, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
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.
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
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
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
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
Serum CEA Levels
Carcinoembryonic antigen (CEA) is a tumor marker for pancreatic cancer.
Time frame: Day 1 (Pre-Injection) and Week 24
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