Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer
This study has been terminated.
(To pursue other indications)
Sponsor:
Reata Pharmaceuticals, Inc.
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
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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
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 May 22, 2013