NCT04672005

Modified FOLFIRINOX Alternated With Biweekly Gemcitabine Plus Nab-Paclitaxel Untreated Pancreatic Cancer

Modified FOLFIRINOX Alternated With Biweekly Gemcitabine Plus Nab-Paclitaxel in Untreated Metastatic Adenocarcinoma of the Pancreas

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Lyudmyla Berim · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the clinical trial is to determine if modified FOLFIRINOX (mFFX) alternated with biweekly Gemcitabine plus Nab-Paclitaxel (mGnabP) administered as a combined, front-line therapy will result in longer time to treatment failure (TTF) compared to the current standard of care with mFFX alone in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (PDAC).

Detailed description

1. Primary objective: To determine whether mFFX and mGnabP administered as a combined, alternating, front-line therapy can provide longer first line treatment for patients with metastatic pancreatic cancer, with the primary metric of time to treatment failure (TTF), including progression of disease (PD), death or treatment discontinuation due to toxicity. • Primary endpoint: TTF (treatment discontinuation due to toxicity, disease progression, or death). 2. Secondary objectives: 1\) To determine objective response rate (ORR) of the regimen. 2) To determine progression-free survival (PFS) rate of the regimen. 3) To determine overall survival (OS) rate of the regimen. 4) To assess biomarker response (CA-19.9) to the regimen. 5) To examine safety and tolerability of the new regimen. 6) To examine health-related quality of life in patients receiving this regimen. • Secondary endpoints: 1. ORR as determined by the proportion of subjects with either complete response (CR) or partial response (PR), as defined by RECIST 1.1. 2. PFS as determined by the time interval from the date of first dose of study regimen to first documented PD or death from any cause, whichever occurs first. 3. Overall survival (OS) as defined as the time interval from the date of the first dose of study regimen to date of death from any cause. 4. Biomarker response, measured by serum CA 19-9 levels every 4 weeks. 5. Safety and tolerability of the mFFX alternating with mGnabP regimen; Grade 3 and 4 toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Follow up for toxicity will be recorded for the first 30 days following the last chemotherapy cycle, and any long-term toxicity will be followed for up to 2 years after completion of study therapy. 3\. Exploratory objectives: 1. To determine the tumor molecular profile prior to initiation of chemotherapy and correlate with treatment response. 2. To analyze ct-DNA as a biomarker of response to therapy and early detection of disease progression.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Folfirinox alternating with Gemcitabine-nab-Paclitaxel	modified Folfirinox every 2 weeks and biweekly Gemcitabine plus Nab-Paclitaxel

Timeline

• Start date: 2021-01-06
• Primary completion: 2024-09-30
• Completion: 2025-06-01
• First posted: 2020-12-17
• Last updated: 2024-05-16

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study