RTA 402 in Advanced Solid Tumors or Lymphoid Malignancies
Completed · Phase 1
Conditions studied: Lymphoid Malignancies, Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT00508807
- Run by
- M.D. Anderson Cancer Center
- People needed
- 21
- Starts
- 2006-04-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2012-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UT MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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