Clinical trial · Interventional
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
NCT00529113CI-TRIAL-00090314terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): To pursue other indications
Summary
Brief summary (as posted)
This study assesses the safety and efficacy of RTA 402 in combination with gemcitabine in patients with unresectable pancreatic cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bardoxolone methyl | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- Phase 1 Cohort 1
- description
- Bardoxolone methyl 150 mg/day x 21 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)
- interventionNames
- Drug: Bardoxolone methyl
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Phase 1 Cohort 2
- description
- Bardoxolone methyl 300 mg /day for 21 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15)
- interventionNames
- Drug: Bardoxolone methyl
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Phase 1 Cohort 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Phase I patients should have treatment naïve pancreatic cancer; however , Phase I patients who have had 1 prior regimen consisting of adjuvant chemo-radiation or adjuvant gemcitabine - as defined within the NCCN guidelines may be enrolled. Phase II patients must have metastatic disease (Stage IV only). * 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: * Prior treatment for current malignancy outside of the adjuvant setting for Phase I * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.