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

NCT00529113 | Terminated Phase 1

• 1 other identifier: 402-C-0702
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Pancreatic Neoplasms; Pancreatic Cancer

Keywords

pancreatic cancer; gemcitabine

Outcome Measures

Primary Outcomes (2)

• Phase I - To determine the maximum tolerated dose (MTD) of RTA 402 in combination with gemcitabine in patients with locally advanced or metastatic pancreatic cancer.

  End of trial

• Phase II - To determine if treatment with RTA 402 in combination with gemcitabine can increase the progression-free survival versus gemcitabine plus placebo in patients with unresectable metastatic pancreatic cancer.

  End of Trial

Secondary Outcomes (6)

• Phase I - To document any preliminary antitumor activity of RTA 402 in this patient population.

  End ofTrial

• Phase I - To characterize the pharmacokinetics (PK) of RTA 402 in this population.

  End of Trial

• Phase II - To determine the overall response rate in patients treated with RTA 402 + gemcitabine and in patients treated with gemcitabine + placebo.

  End of Trial

• Phase II - To determine the 1-year survival in this patient population.

  End of Trial

• Phase II - To determine the toxicities of these regimens.

  End of Trial

Study Arms (9)

Phase 1 Cohort 1

EXPERIMENTAL

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

Drug: Bardoxolone methyl; Drug: Gemcitabine

Phase 1 Cohort 2

EXPERIMENTAL

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

Drug: Bardoxolone methyl; Drug: Gemcitabine

Phase 1 Cohort 3

EXPERIMENTAL

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

Drug: Bardoxolone methyl; Drug: Gemcitabine

Phase 1 Cohort 4

EXPERIMENTAL

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

Drug: Bardoxolone methyl; Drug: Gemcitabine

Phase 1 Cohort 5

EXPERIMENTAL

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

Drug: Bardoxolone methyl; Drug: Gemcitabine

Phase 1 Cohort 6

EXPERIMENTAL

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

Drug: Bardoxolone methyl; Drug: Gemcitabine

Phase 1 Cohort 7

EXPERIMENTAL

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

Drug: Bardoxolone methyl; Drug: Gemcitabine

Phase 2 Cohort 1

EXPERIMENTAL

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)

Drug: Gemcitabine; Drug: Bardoxolone methyl

Phase 2 Cohort 2

PLACEBO COMPARATOR

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

Drug: Gemcitabine; Drug: Placebo

Interventions

Bardoxolone methyl DRUG

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

Also known as: RTA 402

Phase 1 Cohort 1

Gemcitabine DRUG

1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15

Also known as: Gemzar

Phase 1 Cohort 1; Phase 1 Cohort 2; Phase 1 Cohort 3; Phase 1 Cohort 4; Phase 1 Cohort 5; Phase 1 Cohort 6; Phase 1 Cohort 7; Phase 2 Cohort 1; Phase 2 Cohort 2

Placebo DRUG

Placebo capsules x 28 days

Phase 2 Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (5)

Rocky Mountain Cancer Center (US Oncology)

Denver, Colorado, United States

Location

Cancer Centers of Florida (US Oncology)

Ocoee, Florida, United States

Location

Central Indiana Cancer Centers (US Oncology)

Indianapolis, Indiana, United States

Location

Sammons Cancer Center (US Oncology)

Dallas, Texas, 75246, United States

Location

Northwest Cancer Specialist- Vancouver Cancer Specialist (US Oncology)

Vancouver, Washington, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

bardoxolone methyl; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: September 30, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (5)