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

This study has been terminated.
(To pursue other indications)
Sponsor:
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00529113
First received: September 12, 2007
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Pancreatic Neoplasms
Pancreatic Cancer
Drug: RTA 402
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase I/II Study With Gemcitabine and RTA 402 or Gemcitabine and Placebo for Patients With Unresectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Reata Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: End of trial ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: End of Trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase I - To document any preliminary antitumor activity of RTA 402 in this patient population. [ Time Frame: End ofTrial ] [ Designated as safety issue: No ]
  • Phase I - To characterize the pharmacokinetics (PK) of RTA 402 in this population. [ Time Frame: End of Trial ] [ Designated as safety issue: No ]
  • Phase II - To determine the overall response rate in patients treated with RTA 402 + gemcitabine and in patients treated with gemcitabine + placebo. [ Time Frame: End of Trial ] [ Designated as safety issue: No ]
  • Phase II - To determine the 1-year survival in this patient population. [ Time Frame: End of Trial ] [ Designated as safety issue: No ]
  • Phase II - To determine the toxicities of these regimens. [ Time Frame: End of Trial ] [ Designated as safety issue: Yes ]
  • Phase II - To determine the changes in quality of life (Functional Assessment of Chronic Illness Therapy (Fatigue), [FACIT-F]). [ Time Frame: End of Trial ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
RTA 402 150 mg/day x 21 days
Drug: RTA 402
RTA 402 150 mg/day for 21 days
Experimental: 2
RTA 402 300 mg /day for 21 days
Drug: RTA 402
RTA 402 300 mg/day for 21 days
Experimental: 3
RTA 402 150 mg/day for 28 days
Drug: RTA 402
RTA 402 150 mg/day for 28 days
Experimental: 4
RTA 402 200 mg/day for 28 days
Drug: RTA 402
RTA 402 200 mg/day for 28 days
Experimental: 5
RTA 402 250 mg/day for 28 days
Drug: RTA 402
RTA 402 250 mg/day for 28 days
Experimental: 6
RTA 402 300 mg/day x 28 days
Drug: RTA 402
RTA 402 300 mg/day x 28 days
Experimental: 7
RTA 402 350 mg/day x 28 days
Drug: RTA 402
RTA 402 350 mg/day x 28 days

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529113

Locations
United States, Colorado
Rocky Mountain Cancer Center (US Oncology)
Denver, Colorado, United States
United States, Florida
Cancer Centers of Florida (US Oncology)
Ocoee, Florida, United States
United States, Indiana
Central Indiana Cancer Centers (US Oncology)
Indianapolis, Indiana, United States
United States, Iowa
Iowa Blood and Cancer Care (Mary Crowley Cancer Research Center)
Cedar Rapids, Iowa, United States, 52402
United States, Montana
Billings Clinic (Mary Crowley Cancer Research Center)
Billings, Montana, United States, 59101
United States, Texas
Sammons Cancer Center (US Oncology)
Dallas, Texas, United States, 75246
Mary Crowley Cancer Research Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
United States, Washington
Northwest Cancer Specialist- Vancouver Cancer Specialist (US Oncology)
Vancouver, Washington, United States
Sponsors and Collaborators
Reata Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00529113     History of Changes
Other Study ID Numbers: 402-C-0702
Study First Received: September 12, 2007
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Reata Pharmaceuticals, Inc.:
pancreatic cancer
gemcitabine

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 24, 2014