Phase I Study of Gimatecan in Patients With Myelodysplastic Syndromes
|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.
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|