Cabozantinib or Sunitinib Malate in Treating Participants With Metastatic Variant Histology Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03541902|
Recruitment Status : Active, not recruiting
First Posted : May 31, 2018
Last Update Posted : December 14, 2022
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 Chromophobe Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Papillary Renal Cell Carcinoma Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions Sarcomatoid Renal Cell Carcinoma Stage IV Renal Cell Cancer AJCC v8 Unclassified Renal Cell Carcinoma||Drug: Cabozantinib Drug: Sunitinib Malate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 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 31, 2023|
|Estimated Study Completion Date :||July 31, 2023|
Experimental: Group 1 (cabozantinib)
Participants receive cabozantinib PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Experimental: Group 2 (sunitinib malate)
Participants receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Sunitinib Malate
- 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
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|MD Anderson Regional Care Center-Katy|
|Houston, Texas, United States, 77094|
|MD Anderson Regional Care Center-Sugar Land|
|Sugar Land, Texas, United States, 77478|
|Principal Investigator:||Matthew T Campbell||M.D. Anderson Cancer Center|