RTA 402 in Patients With Advanced Solid Tumors or Lymphoid Malignancies
This study has been completed.
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.
First received: September 12, 2007
Last updated: November 4, 2014
Last verified: November 2014
This study assesses the tolerability, safety, efficacy and pharmacokinetics of Bardoxolone methyl (RTA 402) in advanced solid tumors and lymphoid malignancies.
Advanced Solid Tumors
Drug: Bardoxolone methyl
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2008 (Final data collection date for primary outcome measure)
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
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00529438
|Beth Israel Deaconess Medical Center
|Boston, Massachusetts, United States, 02215 |
|Case Western Reserve University
|Cleveland, Ohio, United States, 44106 |
|MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
Reata Pharmaceuticals, Inc.
||Reata Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 12, 2007
||November 4, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2016