Phase II Randomized, Double-Blind Study of mFOLFIRINOX Plus Ramucirumab versus mFOLFIRINOX plus placebo in Advanced Pancreatic Cancer Patients

This is a phase II, multicenter, double-blinded, randomized, 2-arm trial evaluating the efficacy and safety of mFOLFIRINOX plus ramucirumab (Arm A) vs. mFOLFIRINOX plus placebo (Arm B) in up to 95 subjects with advanced pancreatic cancer not amenable to curative treatment. Subjects will be randomized in a 1:1 ratio. Subjects on both arms will continue treatment until disease progression or unacceptable toxicity. Each cycle will be 28 days.

• Condition: Pancreatic cancer
• Intervention:
  • Drug: mFOLFIRINOX
  • Drug: Ramucirumab
  • Other: Placebo
• Phase: Phase II

For full description, see www.clinicaltrials.gov. (Study #NCT02581215).

Read a news release about this trial.

Manuscripts/Articles: 

• Walid L. Shaib, Rupji Manali, Yuan Liu, Bassel El-Rayes, Patrick Loehrer, Bert O’Neil, Steven Cohen, Tina Khair, Erwin Robin, Timothy Huyck, Tanios Bekaii-Saab. Phase II randomized, double-blind, study of mfolfirinox plus ramucirumab versus mfolfirinox plus placebo in advanced pancreatic cancer patients (HCRN GI14-198). European Journal of Cancer, August 2023. See abstract. 

Abstracts/Posters/Presentations:

• Walid Labib Shaib, Manali Rupji, Liu Yuan, El-Rayes Bassel, Loehrer, O’Neil Bert, Cohen Steven, Khair Tina, Robin Erwin, Huyck Timothy, Bekaii-Saab, Tanios. Phase II randomised, double-blind study of mFOLFIRINOX plus ramucirumab versus mFOLFIRINOX plus placebo in advanced pancreatic cancer patients (HCRN GI14-198). Published in the European Journal of Cancer. March 10, 2023DOI:https://doi.org/10.1016/j.ejca.2023.02.030 
• Walid Labib Shaib, Manali Rupji, Tina Ashley Khair, Erwin L. Robin, Bassel F. El-Rayes, Timothy K. Huyck, Yuan Liu, Mohamad Bassam Sonbol, Tanios S. Bekaii-Saab. Phase II randomized, double-blind study of mFOLFIRINOX plus ramucirumab versus mFOLFIRINOX plus placebo in advanced pancreatic cancer patients (HCRN GI14-198). Presented as a Poster at the 2021 Gastrointestinal Cancers Symposium, January 15-17, 2021. J Clin Oncol 39, 2021 (suppl 3; abstr 413).
  See abstract.
• Walid Labib Shaib, Bert O’Neil, Bassel F. El-Rayes, Steven J. Cohen, Tina Ashley Khair, Erwin L. Robin, Timothy K. Huyck, Rebecca A. Redman, Ashwin Reddy Sama, Mohamad Kassar, Tanios S. Bekaii-Saab. Phase II randomized, double-blind, study of mfolfirinox plus ramucirumab versus mfolfirinox plus placebo in advanced pancreatic cancer patients HCRN GI14-198. Presented as a Trials in Progress Poster at the 2019 Gastrointestinal Cancers Symposium, January 18, 2019, San Francisco, CA. J Clin Oncol 37, 2019 (suppl 4; abstr TPS475).
  See abstract.