RTA 402 in Advanced Solid Tumors or Lymphoid Malignancies
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
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.