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ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study — PanC-ASAP  

Pancreatic Cancer Clinical Trial

Official title:
A Phase I Open Label Followed by a Phase II Randomized, Controlled Study to Assess the Efficacy and Safety of ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic

Clinical Trial Summary

A Phase I open label followed by a Phase II randomized, controlled study to assess the efficacy and safety of ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic. Funded by: FDA OOPD (Grant #FD-R-006817-01), H2020 EIC Accelerator (Grant #954825) and Ability Pharmaceuticals SL.

Clinical Trial Description

Phase I: This is an open label Phase I to determine the RP2D of ABTL0812 in combination with FOLFIRINOX. All patients will receive ABTL0812 in combination with FOLFIRINOX. A dose de-escalation phase will be performed in which up to 3 different ABTL0812 dose levels will be tested in combination with FOLFIRINOX. ABTL0812 doses are: 1300 mg tid (starting dose), followed (if necessary) by 975 mg tid and 650 mg tid. Patient intra-escalation is not allowed. Phase II: This is a double blind, randomized, placebo-controlled Phase II multicenter study to evaluate ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic cancer. Patients will be randomized to one of two groups: arm A) receiving ABTL0812 in addition to FOLFIRINOX and arm B) receiving FOLFIRINOX plus placebo. Arm A) ABTL0812 + FOLFIRINOX Arm B) PLACEBO + FOLFIRINOX ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04431258
Study type Interventional
Source Ability Pharmaceuticals SL
Contact
Status Completed
Phase Phase 1/Phase 2
Start date May 6, 2021
Completion date January 10, 2024
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