Phase I Study of TAS-106 in Combo With Carboplatin
|ClinicalTrials.gov Identifier: NCT00752011|
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : October 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer Solid Tumors||Drug: TAS-106 Drug: Carboplatin||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose Escalating Study Of Tas-106 In Combination With Carboplatin In Patients With Solid Tumors|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||October 2012|
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
- Maximum tolerated dose (MTD) [ Time Frame: With every 3 week cycle ]
- To review relationship between selected biomarkers and efficacy/safety outcomes. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752011
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Aung Naing, MD||M.D. Anderson Cancer Center|