Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)
|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: NCT02060370|
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Genitourinary Cancer Kidney Cancer||Drug: Sunitinib Behavioral: Questionnaire||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Alternative Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma (mRCC)|
|Actual Study Start Date :||August 2014|
|Actual Primary Completion Date :||January 2, 2019|
|Actual Study Completion Date :||January 2, 2019|
Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.
Other Name: Survey
- Rate of Toxicity [ Time Frame: 12 weeks ]Composite rate of toxicity defined as percentage of patients who experience one or more of the following ≥grade 3 toxicities using Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.03 criteria that are possibly, probably, or definitely related to study therapy: fatigue, hand-foot syndrome (HFS), or diarrhea.
- Progression-Free Survival (PFS) [ Time Frame: Day 35 of second, 12 week cycle ]Progression-free survival (PFS) defined as time from treatment initiation to disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1 or death. PFS measured from the date of initiation of treatment to the first of documented progression or death; estimated using Kaplan-Meier method.
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): NCT02060370
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|United States, North Carolina|
|Lineberger Cancer Center|
|Chapel Hill, North Carolina, United States, 27514|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eric Jonasch, MD||M.D. Anderson Cancer Center|