RTA 402 in Patients With Advanced Solid Tumors or Lymphoid Malignancies

NCT00529438 | Completed Phase 1

• 1 other identifier: 402-C-0501
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Advanced Solid Tumors; Lymphoid Malignancies

Outcome Measures

Primary Outcomes (2)

• To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of Bardoxolone methyl Capsules

  28 day cycles, with a maximum of 18 cycles (18 months)

• To characterize the pharmacokinetics of Bardoxolone methyl in this patient population.

  28 day cycles, with a maximum of 18 cycles (18 months)

Secondary Outcomes (3)

• To document any preliminary antitumor activity.

  28 day cycles, with a maximum of 18 cycles (18 months)

• To determine the in vivo molecular and biological effects.

  28 day cycles, with a maximum of 18 cycles (18 months)

• To correlate the biological activity of RTA 402 with drug concentration in plasma and blood cellular elements.

  28 day cycles, with a maximum of 18 cycles (18 months)

Study Arms (1)

Bardoxolone methyl capsules

EXPERIMENTAL

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

Interventions

Bardoxolone methyl DRUG

Also known as: RTA 402

Bardoxolone methyl capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

bardoxolone methyl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: April 30, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (3)