Cabozantinib Versus Sunitinib for Metastatic Variant Histology Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03541902|
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : August 15, 2018
The goal of this clinical research study is to compare the safety and effectiveness of cabozantinib and sunitinib when given to patients with metastatic (has spread) variant histology renal cell carcinoma (vhRCC), a type of kidney cancer.
This is an investigational study. Cabozantinib and sunitinib are both FDA approved and commercially available for the treatment of advanced kidney cancer, including vhRCC.
The study doctor can explain how the study drugs are designed to work.
Up to 84 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasms of Urinary Tract Renal Cell Carcinoma||Drug: Cabozantinib Drug: Sunitinib||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cabosun II: Cabozantinib Versus Sunitinib for Metastatic Variant Histology Renal Cell Carcinoma|
|Actual Study Start Date :||May 15, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Cabozantinib Group
Participants take Cabozantinib 60 mg tablets by mouth 1 time a day.
Each study cycle is 6 weeks.
60 mg by mouth 1 time a day at about the same time every day while on study.
Experimental: Sunitinib Group
Participants take Sunitinib 50 mg tablets by mouth 1 time a day on Days 1-28 and then not take any drug between Days 29-42.
50 mg by mouth 1 time a day on Days 1-28 then not take any drug between Days 29-42.
- Progression-Free Survival (PFS) Evaluated Using RECIST 1.1 Criteria [ Time Frame: From randomization up to the time of disease progression or death up to two years ]PFS defined as the time from randomization to progression or death, regardless of cause, whichever comes first.
- Objective Response Rate (ORR) Evaluated Using RECIST 1.1 Criteria [ Time Frame: From randomization up to the time of disease progression or death up to two years ]ORR is the best response recorded from the start of treatment until disease progression/recurrence (taking into consideration confirmation of response and reference for progressive disease the smallest measurements recorded since the treatment started).
- Overall Survival (OS) [ Time Frame: From randomization to death or last contact if still alive up to two years ]OS defined as the time from randomization to death or last contact if still alive.
- Adverse Event Rates [ Time Frame: Start of study drug up to 30 days after last dose of study drug ]Adverse events recorded by CTCAE version 4.0
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): NCT03541902
|Contact: Matthew Campbell, MDemail@example.com|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|MD Anderson Katy Regional Care Center||Recruiting|
|Houston, Texas, United States, 77094|
|MD Anderson Sugarland Regional Care Center||Recruiting|
|Sugar Land, Texas, United States, 77478|
|Principal Investigator:||Matthew Campbell, MD||M.D. Anderson Cancer Center|