RTA 402 in Advanced Solid Tumors or Lymphoid Malignancies
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.
Timeline
- Start
- 2006-04
- Primary completion
- 2009-12
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bardoxolone methyl | Small molecule | 5 mg | Oral |