NCT00529113 - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

November 1, 2009

Study Completion Date

November 1, 2009

Conditions

Pancreatic NeoplasmsPancreatic Cancer

Interventions

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

Trial Locations (5)

75246

Sammons Cancer Center (US Oncology), Dallas

Unknown

Rocky Mountain Cancer Center (US Oncology), Denver

Cancer Centers of Florida (US Oncology), Ocoee

Central Indiana Cancer Centers (US Oncology), Indianapolis

Northwest Cancer Specialist- Vancouver Cancer Specialist (US Oncology), Vancouver