Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer
NCT ID: NCT00529113
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
33 participants
INTERVENTIONAL
2007-09-30
2009-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
NCT01746979
A Safety and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer
NCT01028495
Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
NCT00593008
Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer
NCT03498326
Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine
NCT00550004
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase 1 Cohort 1
Bardoxolone methyl 150 mg/day x 21 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)
Bardoxolone methyl
Bardoxolone methyl capsules (150 mg/day) for 21 days
Gemcitabine
1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
Phase 1 Cohort 2
Bardoxolone methyl 300 mg /day for 21 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)
Bardoxolone methyl
Bardoxolone methyl capsules (300 mg/day) for 21 days
Gemcitabine
1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
Phase 1 Cohort 3
Bardoxolone methyl 150 mg/day for 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)
Bardoxolone methyl
Bardoxolone methyl capsules (150 mg/day) for 28 days
Gemcitabine
1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
Phase 1 Cohort 4
Bardoxolone methyl 200 mg/day for 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)
Bardoxolone methyl
Bardoxolone methyl capsules (200 mg/day) for 28 days
Gemcitabine
1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
Phase 1 Cohort 5
Bardoxolone methyl 250 mg/day for 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)
Bardoxolone methyl
Bardoxolone methyl capsules (250 mg/day) for 28 days
Gemcitabine
1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
Phase 1 Cohort 6
Bardoxolone methyl 300 mg/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)
Bardoxolone methyl
Bardoxlone methyl capsules (300 mg/day) x 28 days
Gemcitabine
1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
Phase 1 Cohort 7
Bardoxolone methyl 350 mg/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)
Bardoxolone methyl
Bardoxolone methyl capsules (350 mg/day) x 28 days
Gemcitabine
1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
Phase 2 Cohort 1
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)
Gemcitabine
1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
Bardoxolone methyl
Bardoxolone methyl maximum tolerated dose (as determined in the Phase 1 portion of the study)/day x 28 days
Phase 2 Cohort 2
Placebo capsules/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)
Gemcitabine
1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
Placebo
Placebo capsules x 28 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bardoxolone methyl
Bardoxolone methyl capsules (150 mg/day) for 21 days
Bardoxolone methyl
Bardoxolone methyl capsules (300 mg/day) for 21 days
Bardoxolone methyl
Bardoxolone methyl capsules (150 mg/day) for 28 days
Bardoxolone methyl
Bardoxolone methyl capsules (200 mg/day) for 28 days
Bardoxolone methyl
Bardoxolone methyl capsules (250 mg/day) for 28 days
Bardoxolone methyl
Bardoxlone methyl capsules (300 mg/day) x 28 days
Bardoxolone methyl
Bardoxolone methyl capsules (350 mg/day) x 28 days
Gemcitabine
1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
Placebo
Placebo capsules x 28 days
Bardoxolone methyl
Bardoxolone methyl maximum tolerated dose (as determined in the Phase 1 portion of the study)/day x 28 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Karnofsky performance status of \>70%
* Adequate liver function. (total bilirubin ≤ 1.5 mg/dL and AST(SGOT) and ALT(SGPT) of \< 2.5 ULN ( ≤ 5 ULN for Phase II patients with liver metastases), Serum Creatinine \< 1.5 ULN
* Adequate bone marrow function as documented by the following laboratory test results within 14 days of starting therapy. platelets ≥100,000/mm3, absolute neutrophil count (ANC) ≥1500/mm3, hemoglobin ≥9.0 g/dL, white blood cell (WBC) count ≥3000 /mm3
* Practice effective contraception during the entire study period.
* Life expectancy of more than 3 months.
* Able and willing to sign the informed consent form.
* Willing and able to self-administer orally and document all doses of RTA 402 ingested.
Exclusion Criteria
* Inability to swallow tablets or capsules
* Active brain metastases or primary central nervous system (CNS) malignancies. (Patients with a previously treated brain metastasis may be included.)
* Active second malignancy
* Ten percent or greater weight loss over the 6 weeks before study entry.
* Pregnant or breast feeding
* Clinically significant illnesses which could compromise participation in the study, including, but not limited to: Uncontrolled diabetes; Active or uncontrolled infection; Acute or chronic liver disease; Confirmed diagnosis of Human immunodeficiency virus (HIV) infection; Uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, or uncontrolled cardiac arrhythmia.
* Psychiatric illness that would limit compliance with study requirements.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biogen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Northwest Cancer Specialist- Vancouver Cancer Specialist (US Oncology)
Vancouver, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
402-C-0702
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.