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

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Brief Title

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

Official Title

A Randomized Phase I/II Study With Gemcitabine and RTA 402 or Gemcitabine and Placebo for Patients With Unresectable Pancreatic Cancer

Brief Summary

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

Detailed Description

      Phase I will be conducted to determine the MTD of RTA 402 (administered orally Days 1-21 or
      Days 1-28 of a 28-day cycle) in combination with gemcitabine (1000 m/m2). Gemcitabine will be
      administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle.

      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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

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.

Secondary Outcome

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

Condition

Pancreatic Neoplasms

Intervention

Bardoxolone methyl

Study Arms / Comparison Groups

 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)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

33

Start Date

September 2007

Completion Date

November 2009

Primary Completion Date

November 2009

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00529113

Organization ID

402-C-0702


Responsible Party

Sponsor

Study Sponsor

Reata Pharmaceuticals, Inc.


Study Sponsor

, , 


Verification Date

November 2014