NCT00529113

Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer

A Randomized Phase I/II Study With Gemcitabine and RTA 402 or Gemcitabine and Placebo for Patients With Unresectable Pancreatic Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study assesses the safety and efficacy of RTA 402 in combination with gemcitabine in patients with unresectable pancreatic cancer.

Detailed description

Phase I will be conducted to determine the MTD of RTA 402 (administered orally Days 1-21 or Days 1-28 of a 28-day cycle) in combination with gemcitabine (1000 m/m2). Gemcitabine will be administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle. The phase II portion of the study will be randomized, and double-blinded. Phase II will utilize the RTA 402 MTD determined in Phase I; Arm 1 will consist of gemcitabine + RTA 402. RTA 402 capsules will administered orally Days 1-21 of each 28-day cycle (or Days 1-28 if appropriate, based on phase I results); gemcitabine (1000 mg/m2) will be administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle in each Arm. Arm 2 will consist of gemcitabine + placebo, placebo capsules will be taken orally Days 1-21 of each 28-day cycle (or Days 1-28 if appropriate, based on phase I results). Both treatment arms are 4-weeks in length. The study was conceived with both a Phase I and Phase II portion as described above; however, only the Phase I portion was completed. The trial was terminated in 2009 before the Phase II portion could begin.

Conditions

• Pancreatic Neoplasms
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Bardoxolone methyl	Bardoxolone methyl capsules (150 mg/day) for 21 days
DRUG	Bardoxolone methyl	Bardoxolone methyl capsules (300 mg/day) for 21 days
DRUG	Bardoxolone methyl	Bardoxolone methyl capsules (150 mg/day) for 28 days
DRUG	Bardoxolone methyl	Bardoxolone methyl capsules (200 mg/day) for 28 days
DRUG	Bardoxolone methyl	Bardoxolone methyl capsules (250 mg/day) for 28 days
DRUG	Bardoxolone methyl	Bardoxlone methyl capsules (300 mg/day) x 28 days
DRUG	Bardoxolone methyl	Bardoxolone methyl capsules (350 mg/day) x 28 days
DRUG	Gemcitabine	1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
DRUG	Placebo	Placebo capsules x 28 days
DRUG	Bardoxolone methyl	Bardoxolone methyl maximum tolerated dose (as determined in the Phase 1 portion of the study)/day x 28 days

Timeline

• Start date: 2007-09-30
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2007-09-14
• Last updated: 2025-05-29

Locations

5 sites across 1 country: United States