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
|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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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
|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.
No publications provided
||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 February 11, 2016