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Gastrointestinal Neoplasms

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Gastrointestinal Diseases

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All Drugs and Chemicals

Gemcitabine

Antimetabolites

Bardoxolone methyl 150 mg/day x 21 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)

Bardoxolone methyl 300 mg /day for 21 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)

Bardoxolone methyl 150 mg/day for 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)

Bardoxolone methyl 200 mg/day for 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)

Bardoxolone methyl 250 mg/day for 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)

Bardoxolone methyl 300 mg/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)

Bardoxolone methyl 350 mg/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)

Bardoxolone methyl maximum tolerated dose(as determined in the Phase 1 portion of the study)/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)

Placebo capsules/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)

Bardoxolone methyl capsules (150 mg/day) for 21 days

Bardoxolone methyl

Bardoxolone methyl capsules (300 mg/day) for 21 days

Bardoxolone methyl capsules (150 mg/day) for 28 days

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

Bardoxolone methyl maximum tolerated dose (as determined in the Phase 1 portion of the study)/day x 28 days

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 Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

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

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Reata, a wholly owned subsidiary of Biogen

Bardoxolone methyl to be taken orally for 21 consecutive days, once a day, in the morning prior to food intake.

Patients to continue to receive treatment for the first 21 days of each 28-day cycle until they experience intolerable toxicity, show evidence of disease progression, or receive a maximum of 18 cycles (18 months).

This study assesses the tolerability, safety, efficacy and pharmacokinetics of Bardoxolone methyl (RTA 402) in advanced solid tumors and lymphoid malignancies.

Bardoxolone methyl (RTA 402) is a synthetic triterpenoid that has demonstrated significant in vivo single agent anti-cancer activity. This is an open-label phase I dose-escalation study of Bardoxolone methyl (RTA 402) administered orally for the first 21 days of a 28-day cycle.

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

RTA 402 in Patients With Advanced Solid Tumors or Lymphoid Malignancies

A Phase I Dose-finding and Pharmacokinetic Study of RTA 402 (CDDOMe) Administered Orally for 21 Days of a 28-day Cycle in Patients With Advanced Solid Tumors or Lymphoid Malignancies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer	NCT00529113	Pancreatic Neop... Pancreatic Canc...	Bardoxolone met... Bardoxolone met... Bardoxolone met... Bardoxolone met... Bardoxolone met... Bardoxolone met... Bardoxolone met... Gemcitabine Placebo Bardoxolone met...	18 Years -	Biogen
RTA 402 in Patients With Advanced Solid Tumors or Lymphoid Malignancies	NCT00529438	Advanced Solid ... Lymphoid Malign...	Bardoxolone met...	18 Years -	Biogen
Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer	NCT00529113	Pancreatic Neop... Pancreatic Canc...	Bardoxolone met... Bardoxolone met... Bardoxolone met... Bardoxolone met... Bardoxolone met... Bardoxolone met... Bardoxolone met... Gemcitabine Placebo Bardoxolone met...	18 Years -	Biogen
RTA 402 in Patients With Advanced Solid Tumors or Lymphoid Malignancies	NCT00529438	Advanced Solid ... Lymphoid Malign...	Bardoxolone met...	18 Years -	Biogen
RTA 402 in Patients With Advanced Solid Tumors or Lymphoid Malignancies	NCT00529438	Advanced Solid ... Lymphoid Malign...	Bardoxolone met...	18 Years -	Biogen

Spots Global Cancer Trial Database for bardoxolone methyl