Phase I Study of TAS-106 in Combo With Carboplatin
The goal of this clinical research study is to find the highest safe dose of the combination of TAS-106 and carboplatin that can be given to patients with advanced cancer or cancer that has spread.
To determine the maximum tolerated dose (MTD) of the combination of TAS-106 and carboplatin administered by intravenous infusion every 3 weeks.
To perform Pharmacokinetic (PK) analysis of TAS-106 and carboplatin
To assess the antitumor activity of TAS-106 combined with carboplatin
To investigate the relationship between selected biomarkers and efficacy and safety outcomes.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Dose Escalating Study Of Tas-106 In Combination With Carboplatin In Patients With Solid Tumors|
- Maximum tolerated dose (MTD) [ Time Frame: With every 3 week cycle ] [ Designated as safety issue: Yes ]
- To review relationship between selected biomarkers and efficacy/safety outcomes. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2008|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Carboplatin + TAS-106
Carboplatin starting dose AUC of 4, administered by vein over 60 minutes, Day 1 of 3 Week Cycle. TAS-106 starting dose 2.0 mg/m^2 by vein over 24 hours, Day 1 of 3 Week Cycle.
Starting dose 2.0 mg/m^2 by vein over 24 hours, Day 1 of 3 Week Cycle.Drug: Carboplatin
Starting dose AUC of 4, administered by vein over 60 minutes, Day 1 of 3 Week Cycle.
Other Name: Paraplatin
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Aung Naing, MD||M.D. Anderson Cancer Center|