Phase I Study of Gimatecan in Patients With Myelodysplastic Syndromes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00493571|
Recruitment Status : Completed
First Posted : June 28, 2007
Last Update Posted : May 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes MDS||Drug: Gimatecan||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Gimatecan in Patients With Myelodysplastic Syndromes|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Gimatecan Starting dose: 0.6 mg capsules administered orally once daily.
Starting dose: 0.6 mg capsules administered orally once daily.
- Maximum Tolerated Dose (MTD) of Gimatecan [ Time Frame: Evaulate with each 28 Day Cycle ]For purposes of estimating the MTD, 5 dose levels of Gimatecan initially considered. These dose levels are 3 mg, 5 mg, 7.5 mg, 8.75 mg, and 10 mg orally per cycle. Dose escalation based on toxicities observed through the first cycle.
- Efficacy in terms of complete remission , complete remission w/ incomplete platelet or neutrophil recovery (CRp and CRn, respectively), partial remission , and hematologic improvement. [ Time Frame: Up to 12 Months on Study ]Response criteria according to the International Working Group (Blood 2006; 108: 419-425). Responders are patients who obtain a Complete Response (CR), CRi, Partial Response (PR), with or without cytogenetic response, hematologic improvements, and morphologic leukemia-free state.
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): NCT00493571
|United States, Texas|
|The University of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jorge E. Cortes, MD||M.D. Anderson Cancer Center|