Safety Study of X-82 in Patients With Advanced 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: NCT01296581|
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: X-82||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I, First in Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of X-82 in Patients With Advanced Solid Tumors|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2017|
Dose escalation starting at 20 mg, oral once or twice a day, 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
- Maximum Tolerated Dose [ Time Frame: 12 months ]To determine the maximum tolerated dose (MTD) of X-82 as a single agent.
- Pharmacokinetics [ Time Frame: 12 months ]To characterize the preliminary pharmacokinetics (PK) of X-82 given as a single agent.
- Preliminary biological activity [ Time Frame: 18 months ]To explore the preliminary biological activity and clinical tumor response after treatment with X-82 given as a single agent.
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): NCT01296581
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|