RTA 402 in Advanced Solid Tumors or Lymphoid Malignancies

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary:

• To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of RTA 402 capsules in patients with advanced solid tumors or lymphoid malignancies who have failed standard-of-care curative or survival-prolonging therapy, or for whom no such therapies exist.

• To characterize the pharmacokinetics of RTA 402 capsules administered orally for 21 days in this patient population.

Secondary:

• To document any preliminary antitumor activity of RTA 402 in this patient population.

• To determine the in vivo molecular and biological effects of RTA 402 by measuring changes in markers of differentiation, apoptosis, and anti-inflammatory effects in WBCs, blood plasma, and, in consenting patients, tumor biopsies.

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

• To evaluate the series of inflammation related symptoms over the course of the study, and to determine the correlation of symptom intensity with plasma cytokines.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Reata Pharmaceuticals, Inc.

Criteria

Inclusion:

1. Age >/= 18 years

2. Patient must have histopathological documentation of solid tumor or lymphoid malignancy. (measurable disease is not required)

3. Patient must have advanced or metastatic cancer that are either refractory or has relapsed after standard-of-care curative or survival-prolonging therapy, or for whom no such therapies exist. (there is no limit on the number of prior lines of therapy)

4. Patient must be ECOG performance status of less than or equal to 2.

5. Patient must have adequate liver and renal function as documented by the following laboratory test results within 14 days of starting therapy:

• total bilirubin
• AST (SGOT) and ALT(SGPT) -
• creatinine60 mL/min

6. Patient must have adequate bone marrow function as documented by the following laboratory test results within 14 days of starting therapy:

• platelets greater than 100,000/mm^3,

• absolute granulocyte count greater than 1,500/mm^3,

• hemoglobin greater than or equal to 8.0 g/dl.

7. Patient must have completed prior chemotherapy, hormonal therapy, radiation therapy, biological therapy, or other investigational cancer therapy at least 4 weeks prior to starting RTA 402, 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.

8. Patient (man or woman) must agree to practice effective contraception during the entire study period unless documentation of infertility exists.

9. Patient must have a life expectancy of more than 3 months.

10. Patient must be able and willing to sign the informed consent form.

11. Patient must be willing and able to self-administer orally and document all doses of RTA 402 ingested.

Exclusion:

1. Patients with active brain metastases or primary CNS malignancies. (patients with a previously treated brain metastasis may be included)

2. Patients who are pregnant or breast feeding

3. Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to:

• uncontrolled diabetes

• active or uncontrolled infection

• acute or chronic liver disease (i.e., hepatitis, cirrhosis)

• 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.

4. Patients with psychiatric illness that would limit compliance with study requirements