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

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reata Pharmaceuticals, Inc.
• Treatments: Gemcitabine

Criteria

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.