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2017-12-01
2023-03-15
2023-03-15
54
NCT03077685
NanOlogy, LLC
NanOlogy, LLC
INTERVENTIONAL
Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma
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).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-02-28 | 2024-03-19 | 2024-06-19 |
2017-03-07 | 2024-06-19 | 2024-06-24 |
2017-03-13 | 2024-06-24 | 2024-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Dose Escalation: NanoPac® 6 mg/mL Intratumorally injected NanoPac® at a volume of up to 20% tumor volume | DRUG: NanoPac®
|
| EXPERIMENTAL: Dose Escalation: NanoPac® 10 mg/mL Intratumorally injected NanoPac® at a volume of up to 20% tumor volume | DRUG: NanoPac®
|
| EXPERIMENTAL: Dose Escalation: NanoPac® 15 mg/mL Intratumorally injected NanoPac® at a volume of up to 20% tumor volume | DRUG: NanoPac®
|
| EXPERIMENTAL: Second Phase: NanoPac® at Best Dose Intratumorally injected NanoPac® at a volume of up to 20% tumor volume. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive two NanoPac® administrations, with the second injection administer | DRUG: NanoPac®
|
| EXPERIMENTAL: Third Phase: NanoPac® at Best Dose Intratumorally injected NanoPac® at a volume of up to 20% tumor volume. The dose administered in the third phase will be determined during the dose escalation phase. Subjects will receive four NanoPac® administrations, with the injections administered one | DRUG: NanoPac®
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | Up to Week 24 for Dose Escalation subjects; up to Week 28 for Second Phase subjects; up to 9 Months for Third Phase subjects. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Day 1 (Pre-Injection) and Week 24 |
| Serum CEA Levels | Carcinoembryonic antigen (CEA) is a tumor marker for pancreatic cancer. | Day 1 (Pre-Injection) and Week 24 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
