Everolimus Versus Sunitinib in Non-Clear Cell Renal Cell Carcinoma
|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: NCT01185366|
Recruitment Status : Active, not recruiting
First Posted : August 19, 2010
Last Update Posted : January 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: Everolimus Drug: Sunitinib||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Everolimus Versus Sunitinib Therapy in Patients With Advanced Non-clear Cell Renal Cell Carcinoma|
|Actual Study Start Date :||August 2010|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
Experimental: Everolimus Group 1
Everolimus 10 mg by mouth once a day.
10 mg by mouth once a day.
Active Comparator: Sunitinib Group 2
Sunitinib 50 mg by mouth daily for 4 weeks on / 2 weeks off.
50 mg by mouth daily for 4 weeks on / 2 weeks off
- Progression-Free Survival (PFS) [ Time Frame: Beginning of every 6 week cycle from baseline to disease progression or intolerable side effects. ]Time to event endpoints descriptively summarized by Kaplan-Meier curves. Evaluation of response follows the Response Evaluation Criteria in Solid Tumors.
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): NCT01185366
|United States, Massachusetts|
|Dana-Farber Cancer Institute/Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Huntsman Cancer Institute - University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Amado Zurita, MD||M.D. Anderson Cancer Center|