This study assesses the safety and efficacy of RTA 402 in combination with gemcitabine in patients with unresectable pancreatic cancer.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Bardoxolone methyl capsules (150 mg/day) for 21 days
Bardoxolone methyl capsules (300 mg/day) for 21 days
Bardoxolone methyl capsules (150 mg/day) for 28 days
Rocky Mountain Cancer Center (US Oncology)
Denver, Colorado, United States
Cancer Centers of Florida (US Oncology)
Ocoee, Florida, United States
Central Indiana Cancer Centers (US Oncology)
Indianapolis, Indiana, United States
Sammons Cancer Center (US Oncology)
Dallas, Texas, United States
Phase I - To determine the maximum tolerated dose (MTD) of RTA 402 in combination with gemcitabine in patients with locally advanced or metastatic pancreatic cancer.
Time frame: End of trial
Phase II - To determine if treatment with RTA 402 in combination with gemcitabine can increase the progression-free survival versus gemcitabine plus placebo in patients with unresectable metastatic pancreatic cancer.
Time frame: End of Trial
Phase I - To document any preliminary antitumor activity of RTA 402 in this patient population.
Time frame: End ofTrial
Phase I - To characterize the pharmacokinetics (PK) of RTA 402 in this population.
Time frame: End of Trial
Phase II - To determine the overall response rate in patients treated with RTA 402 + gemcitabine and in patients treated with gemcitabine + placebo.
Time frame: End of Trial
Phase II - To determine the 1-year survival in this patient population.
Time frame: End of Trial
Phase II - To determine the toxicities of these regimens.
Time frame: End of Trial
Phase II - To determine the changes in quality of life (Functional Assessment of Chronic Illness Therapy (Fatigue), [FACIT-F]).
Time frame: End of Trial
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bardoxolone methyl capsules (200 mg/day) for 28 days
Bardoxolone methyl capsules (250 mg/day) for 28 days
Bardoxlone methyl capsules (300 mg/day) x 28 days
Bardoxolone methyl capsules (350 mg/day) x 28 days
1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
Placebo capsules x 28 days
Bardoxolone methyl maximum tolerated dose (as determined in the Phase 1 portion of the study)/day x 28 days
Northwest Cancer Specialist- Vancouver Cancer Specialist (US Oncology)
Vancouver, Washington, United States