Sunitinib Malate in Refractory Germ Cell Tumors
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|ClinicalTrials.gov Identifier: NCT00912912|
Recruitment Status : Terminated (Slow Accrual)
First Posted : June 3, 2009
Results First Posted : January 27, 2016
Last Update Posted : April 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Genitourinary Disease||Drug: Sunitinib Malate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Sunitinib Malate in Refractory Germ Cell Tumors|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Sunitinib Malate
Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
Drug: Sunitinib Malate
50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
- 12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate [ Time Frame: 12 weeks ]Measurable disease or response recorded from start of treatment until disease progression/recurrence. Participants who die during therapy or are lost to follow-up shall be counted as progressive disease. Progressive disease defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Evaluation of measurable disease response follows Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
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): NCT00912912
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Lance Pagliaro, MD, BA||M.D. Anderson Cancer Center|