Safety Study of X-82 in Patients With Advanced Solid Tumors
|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|
|Primary Completion Date :||January 2014|
|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.
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|