RTA 402 in Patients With Advanced Solid Tumors or Lymphoid Malignancies

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529438
• Other study ID #: 402-C-0501
• Status: Completed
• Phase: Phase 1
• Start date: April 30, 2006
• Est. completion date: December 1, 2008

Study information

• Verified date: February 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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. Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 1, 2008
• Est. primary completion date: December 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Lymphoid Malignancies
• Neoplasms

Intervention

Drug:
• Bardoxolone methyl

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Case Western Reserve University	Cleveland	Ohio
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Reata, a wholly owned subsidiary of Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	To characterize the pharmacokinetics of Bardoxolone methyl in this patient population.		28 day cycles, with a maximum of 18 cycles (18 months)
Secondary	To document any preliminary antitumor activity.		28 day cycles, with a maximum of 18 cycles (18 months)
Secondary	To determine the in vivo molecular and biological effects.		28 day cycles, with a maximum of 18 cycles (18 months)
Secondary	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)