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RTA 402 in Patients With Advanced Solid Tumors or Lymphoid Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00529438
First received: September 12, 2007
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

This study assesses the tolerability, safety, efficacy and pharmacokinetics of Bardoxolone methyl (RTA 402) in advanced solid tumors and lymphoid malignancies.


Condition Intervention Phase
Advanced Solid Tumors
Lymphoid Malignancies
Drug: Bardoxolone methyl
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose-finding and Pharmacokinetic Study of RTA 402 (CDDOMe) Administered Orally for 21 Days of a 28-day Cycle in Patients With Advanced Solid Tumors or Lymphoid Malignancies

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of Bardoxolone methyl Capsules [ Time Frame: 28 day cycles, with a maximum of 18 cycles (18 months) ] [ Designated as safety issue: No ]
  • To characterize the pharmacokinetics of Bardoxolone methyl in this patient population. [ Time Frame: 28 day cycles, with a maximum of 18 cycles (18 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To document any preliminary antitumor activity. [ Time Frame: 28 day cycles, with a maximum of 18 cycles (18 months) ] [ Designated as safety issue: No ]
  • To determine the in vivo molecular and biological effects. [ Time Frame: 28 day cycles, with a maximum of 18 cycles (18 months) ] [ Designated as safety issue: No ]
  • To correlate the biological activity of RTA 402 with drug concentration in plasma and blood cellular elements. [ Time Frame: 28 day cycles, with a maximum of 18 cycles (18 months) ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bardoxolone methyl capsules

Bardoxolone methyl to be taken orally for 21 consecutive days, once a day, in the morning prior to food intake.

Patients to continue to receive treatment for the first 21 days of each 28-day cycle until they experience intolerable toxicity, show evidence of disease progression, or receive a maximum of 18 cycles (18 months).

Drug: Bardoxolone methyl
Other Name: RTA 402

Detailed Description:

Bardoxolone methyl (RTA 402) is a synthetic triterpenoid that has demonstrated significant in vivo single agent anti-cancer activity. This is an open-label phase I dose-escalation study of Bardoxolone methyl (RTA 402) administered orally for the first 21 days of a 28-day cycle.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathological documentation of solid tumor or lymphoid malignancy.
  • Advanced or metastatic cancer that is either refractory to or have relapsed after standard-of-care curative or survival-prolonging therapy, or for whom no such therapies exist.
  • ECOG performance status of less than or equal to 2
  • Adequate liver and renal function as documented by the following laboratory test results within 14 days of starting therapy: total bilirubin ≤ 1.5 mg/dL; AST (SGOT) and ALT(SGPT) ≤ 2.5 ULN or ≤ 5 ULN if liver is involved by tumor; serum creatinine ≤2.0 mg/dL OR creatinine clearance >60 mL/min.
  • Adequate bone marrow function as documented by the following laboratory test results within 14 days of starting therapy: platelets greater than 100,000/mm3, absolute granulocyte count greater than 1,500/mm3, hemoglobin greater than or equal to 8.0 g/dl.
  • Completion of prior chemotherapy, hormonal therapy, radiation therapy, biological therapy, or other investigational cancer therapy, for at least 4 weeks prior to study entry and must have recovered from all acute side effects (to CTC grade 1 or less) prior to initiation of RTA 402. Patients who were receiving mitomycin C or nitrosoureas must be 6 weeks from the last administration of chemotherapy.
  • Agree to 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:

  • Active brain metastases or primary CNS malignancies.
  • Pregnant or breast feeding
  • Clinically significant illnesses including, but not limited to: Uncontrolled diabetes; Active or uncontrolled infection; Acute or chronic liver disease; Confirmed diagnosis of 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: NCT00529438

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Reata Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00529438     History of Changes
Other Study ID Numbers: 402-C-0501
Study First Received: September 12, 2007
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on March 01, 2015