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).
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,
2. Secondary objectives:
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.
ORR as determined by the proportion of subjects with either complete response (CR) or
partial response (PR), as defined by RECIST 1.1.
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.
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.
Biomarker response, measured by serum CA 19-9 levels every 4 weeks.
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.
To determine the tumor molecular profile prior to initiation of chemotherapy and
correlate with treatment response.
To analyze ct-DNA as a biomarker of response to therapy and early detection of disease
Metastatic Pancreatic Cancer
Folfirinox alternating with Gemcitabine-nab-Paclitaxel
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.