Carfilzomib in Refractory Renal Cell Carcinoma (RCC)
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|ClinicalTrials.gov Identifier: NCT01775930|
Recruitment Status : Completed
First Posted : January 25, 2013
Results First Posted : March 4, 2020
Last Update Posted : March 4, 2020
The goal of this clinical research study is learn if carfilzomib can help control kidney cancer. The safety of this drug will also be studied.
Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells cannot repair themselves, this may cause them to die.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: Carfilzomib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Carfilzomib in Patients With Refractory Renal Cell Carcinoma|
|Actual Study Start Date :||October 2013|
|Actual Primary Completion Date :||January 18, 2019|
|Actual Study Completion Date :||January 18, 2019|
Patients receive Carfilzomib at dose of 20 mg/m2 over 30 minutes by vein infusion on Days 1 and 2 and a dose of 56 mg/m2 over 30 minutes by vein infusion on Days 8, 9, 15, and 16 of each 4 week cycle.
20 mg/m2 over 30 minutes by vein infusion on Days 1 and 2 and a dose of 56 mg/m2 over 30 minutes by vein infusion on Days 8, 9, 15, and 16 of each 4 week cycle.
- Progression Free Survival (PFS) of Carfilzomib Therapy in Participants With Refractory Or Intolerant to Prior Therapy [ Time Frame: The number of months from enrollment to progression of cancer or death, whichever comes first up to 4 months ]Progression free survival defined as time from enrollment to progression or death, whichever comes first. Progression defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Any patients who are alive and free of disease at time of analysis censored at date of most recent tumor assessment.
- Overall Response Rate (ORR) [ Time Frame: Participants response was evaluated every 8 weeks from the first dose of carfilzomib until progression od disease (PD), up to 4 months ]The number of participants had a complete response (CR, complete reduction in tumor burden) or partial response (PR, a reduction in tumor burden of at least 30%) as determined for radiographic imaging such as a CT scan. Participants who do not have a reduction in tumor burden will either have stable disease (SD) or progressive disease (PD, which is an increase in tumor burden of at least 20%). The results are based on the best response that each participant achieved while on treatment.
- Overall Survival (OS) [ Time Frame: 15 months ]The number of months from the time of enrollment until death per participant
- Safety of Carfilzomib [ Time Frame: 4 months ]Reason for stopping therapy
- PFS and ORR as a Function of VHL Mutation Subtype [ Time Frame: No data collected ]
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): NCT01775930
|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|