STAT3 Inhibitor for Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00955812|
Recruitment Status : Completed
First Posted : August 10, 2009
Last Update Posted : February 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer Solid Tumor||Drug: OPB-31121||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-label, Dose Escalation, Non-randomized Study to Assess the Pharmacokinetics, Dose Limiting Toxicity, and Maximum Tolerated Dose of OPB-31121 in Subjects With Advanced Solid Tumors|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
OPB-31121 50 mg by mouth 2 times a day on Days 1-21 of each 28-day cycle.
50 mg by mouth 2 times a day on Days 1-21 of each 28-day cycle.
- Maximum Tolerated Dose (MTD) of OPB-31121 [ Time Frame: 4 Week Cycle ]The MTD is defined as the highest dose level at which < 2 of 6 subjects experience dose limiting toxicity (DLT) during the first cycle.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955812
|United States, Tennessee|
|Sarah Cannon Research Institute (SCRI)|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David S. Hong, MD||UT MD Anderson Cancer Center|