Back to results

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

Primary Purpose

Pancreatic Neoplasms, Pancreatic Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Bardoxolone methyl

Gemcitabine

Placebo

Bardoxolone methyl

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring pancreatic cancer, gemcitabine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rocky Mountain Cancer Center (US Oncology)
Cancer Centers of Florida (US Oncology)
Central Indiana Cancer Centers (US Oncology)
Sammons Cancer Center (US Oncology)
Northwest Cancer Specialist- Vancouver Cancer Specialist (US Oncology)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Placebo Comparator

Arm Label

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

Arm Description

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

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

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

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

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

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

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

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)

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

Outcomes

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.

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.

Secondary Outcome Measures

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

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

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

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

Phase II - To determine the toxicities of these regimens.

Phase II - To determine the changes in quality of life (Functional Assessment of Chronic Illness Therapy (Fatigue), [FACIT-F]).

Full Information

NCT ID

NCT00529113

First Posted

September 12, 2007

Last Updated

February 4, 2022

Sponsor

Reata Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00529113

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

To pursue other indications

Study Start Date

September 2007 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Reata Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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. The study was conceived with both a Phase I and Phase II portion as described above; however, only the Phase I portion was completed. The trial was terminated in 2009 before the Phase II portion could begin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Neoplasms, Pancreatic Cancer

Keywords

pancreatic cancer, gemcitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1 Cohort 1

Arm Type

Experimental

Arm Description

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

Arm Title

Phase 1 Cohort 2

Arm Type

Experimental

Arm Description

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

Arm Title

Phase 1 Cohort 3

Arm Type

Experimental

Arm Description

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

Arm Title

Phase 1 Cohort 4

Arm Type

Experimental

Arm Description

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

Arm Title

Phase 1 Cohort 5

Arm Type

Experimental

Arm Description

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

Arm Title

Phase 1 Cohort 6

Arm Type

Experimental

Arm Description

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

Arm Title

Phase 1 Cohort 7

Arm Type

Experimental

Arm Description

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

Arm Title

Phase 2 Cohort 1

Arm Type

Experimental

Arm Description

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)

Arm Title

Phase 2 Cohort 2

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bardoxolone methyl

Other Intervention Name(s)

RTA 402

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bardoxolone methyl

Other Intervention Name(s)

RTA 402

Intervention Description

Bardoxolone methyl capsules (300 mg/day) for 21 days

Intervention Type

Drug

Intervention Name(s)

Bardoxolone methyl

Other Intervention Name(s)

RTA 402

Intervention Description

Bardoxolone methyl capsules (150 mg/day) for 28 days

Intervention Type

Drug

Intervention Name(s)

Bardoxolone methyl

Other Intervention Name(s)

RTA 402

Intervention Description

Bardoxolone methyl capsules (200 mg/day) for 28 days

Intervention Type

Drug

Intervention Name(s)

Bardoxolone methyl

Other Intervention Name(s)

RTA 402

Intervention Description

Bardoxolone methyl capsules (250 mg/day) for 28 days

Intervention Type

Drug

Intervention Name(s)

Bardoxolone methyl

Other Intervention Name(s)

RTA 402

Intervention Description

Bardoxlone methyl capsules (300 mg/day) x 28 days

Intervention Type

Drug

Intervention Name(s)

Bardoxolone methyl

Other Intervention Name(s)

RTA 402

Intervention Description

Bardoxolone methyl capsules (350 mg/day) x 28 days

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo capsules x 28 days

Intervention Type

Drug

Intervention Name(s)

Bardoxolone methyl

Other Intervention Name(s)

RTA 402

Intervention Description

Bardoxolone methyl maximum tolerated dose (as determined in the Phase 1 portion of the study)/day x 28 days

Primary Outcome Measure Information:

Title

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

Title

Time Frame

End of Trial

Secondary Outcome Measure Information:

Title

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

Time Frame

End ofTrial

Title

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

Time Frame

End of Trial

Title

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

Title

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

Time Frame

End of Trial

Title

Phase II - To determine the toxicities of these regimens.

Time Frame

End of Trial

Title

Phase II - To determine the changes in quality of life (Functional Assessment of Chronic Illness Therapy (Fatigue), [FACIT-F]).

Time Frame

End of Trial

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Rocky Mountain Cancer Center (US Oncology)

City

Denver

State/Province

Colorado

Country

United States

Facility Name

Cancer Centers of Florida (US Oncology)

City

Ocoee

State/Province

Florida

Country

United States

Facility Name

Central Indiana Cancer Centers (US Oncology)

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

Sammons Cancer Center (US Oncology)

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Northwest Cancer Specialist- Vancouver Cancer Specialist (US Oncology)

City

Vancouver

State/Province

Washington

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs