Safety Study of X-82 in Patients With Advanced Solid Tumors
This study is currently recruiting participants.
Verified August 2013 by Tyrogenex
Information provided by (Responsible Party):
First received: February 14, 2011
Last updated: August 13, 2013
Last verified: August 2013
The purpose of this study is to determine the maximum tolerated dose (MTD) of X-82 as a single agent.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
Further study details as provided by Tyrogenex:
Primary Outcome Measures:
- Maximum Tolerated Dose [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]To determine the maximum tolerated dose (MTD) of X-82 as a single agent.
Secondary Outcome Measures:
- Pharmacokinetics [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]To characterize the preliminary pharmacokinetics (PK) of X-82 given as a single agent.
- Preliminary biological activity [ Time Frame: 18 months ] [ Designated as safety issue: No ]To explore the preliminary biological activity and clinical tumor response after treatment with X-82 given as a single agent.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Dose escalation starting at 20 mg, oral once or twice a day, 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296581
|Contact: Gina Courtney, M.D.||615-339-4214||Gina.firstname.lastname@example.org|
|United States, Oklahoma|
|Peggy and Charles Stephens Oklahoma Cancer Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Rachel Higbee 405-271-8777 email@example.com|
|United States, Tennessee|
|Sarah Cannon Research Institute||Recruiting|
|Nashville, Tennessee, United States, 37203|
Sponsors and Collaborators