Gemcitabine and Dasatinib in Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00429234|
Recruitment Status : Completed
First Posted : January 31, 2007
Last Update Posted : April 4, 2013
The goal of this clinical research study is to find the highest tolerable dose of dasatinib in combination with gemcitabine that can be given to patients with advanced solid tumors. The safety of this combination of study drugs will also be studied.
Researchers also want to study the pharmacodynamics (PDs) of this study drug combination. PD testing is used to learn what effect the drugs have on your tumors.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer Solid Tumors||Drug: Dasatinib Drug: Gemcitabine||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Open-Labeled Trial of Gemcitabine and Dasatinib in Advanced Solid Tumors|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Experimental: Dasatinib + Gemcitabine
Dasatinib starting dose 70 mg by mouth daily for Week 1. Cycle is 28 days, except Cycle 1 which is 8 weeks. Gemcitabine starting dose of 800 mg/m^2 by vein once weekly over 30 minutes beginning Cycle 1 Day 1. All other cycles once weekly for 7 weeks on Days 8, 15, 22, 29, 36, and 43. Cycle is 28 days, except Cycle 1 which is 8 weeks.
Starting dose 70 mg by mouth daily for Week 1. Cycle is 28 days, except Cycle 1 which is 8 weeks.
Other Names:Drug: Gemcitabine
Starting dose of 800 mg/m^2 by vein once weekly over 30 minutes beginning Cycle 1 Day 1. All other cycles once weekly for 7 weeks on Days 8, 15, 22, 29, 36, and 43. Cycle is 28 days, except Cycle 1 which is 8 weeks.
- Maximum tolerated combination doses (MTD) [ Time Frame: 8 week cycle for Cycle 1, all other cycles 28 days ]
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): NCT00429234
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David S. Hong, MD||M.D. Anderson Cancer Center|