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

NCT00529113 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-05-29

No results posted yet for this study

Summary

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

Conditions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-11-01
Completion
2009-11-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00529113 on ClinicalTrials.gov