RTA 402 in Advanced Solid Tumors or Lymphoid Malignancies
|ClinicalTrials.gov Identifier: NCT00508807|
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : July 30, 2012
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoid Malignancies Solid Tumors||Drug: RTA 402||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study Protocol RTA 402-C-0501: A Phase I Dose-finding and Pharmacokinetic Study of RTA 402 (CDDO-Me) Administered Orally for 21 Days of a 28-day Cycle in Patients With Advanced Solid Tumors or Lymphoid Malignancies|
|Study Start Date :||April 2006|
|Primary Completion Date :||December 2009|
|Study Completion Date :||December 2009|
Experimental: RTA 402
5 mg PO daily x 21 days
Drug: RTA 402
5 mg by mouth (PO) daily for 21 days
- Maximum Tolerated Dose of RTA 402 [ Time Frame: 28 day cycles ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508807
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David S. Hong, MD||M.D. Anderson Cancer Center|