A Randomized Phase I/II Study With Gemcitabine and RTA 402 or Gemcitabine and Placebo for 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
End of trial
United States: Food and Drug Administration
|University of Texas Southwestern Medical Center||Dallas, Texas|
|Mary Crowley Cancer Research Center||Dallas, Texas 75246|
|Rocky Mountain Cancer Center (US Oncology)||Denver, Colorado|
|Cancer Centers of Florida (US Oncology)||Ocoee, Florida|
|Central Indiana Cancer Centers (US Oncology)||Indianapolis, Indiana|
|Iowa Blood and Cancer Care (Mary Crowley Cancer Research Center)||Cedar Rapids, Iowa 52402|
|Billings Clinic (Mary Crowley Cancer Research Center)||Billings, Montana 59101|
|Sammons Cancer Center (US Oncology)||Dallas, Texas 75246|
|Northwest Cancer Specialist- Vancouver Cancer Specialist (US Oncology)||Vancouver, Washington|