Status:
COMPLETED
CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
Lead Sponsor:
Calithera Biosciences, Inc
Conditions:
Advanced Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) ve...
Eligibility Criteria
Inclusion
- Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component
- Adult patients
- Karnofsky Performance Score (KPS) ≥ 70%
- Measurable Disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- 1-2 lines of prior therapy for advanced or metastatic renal cell carcinoma (RCC) including one anti-angiogenic therapy (any vascular endothelial growth factor \[VEGF\] pathway-targeted agent used either as monotherapy or as a component of a combination regimen) OR the combination regimen of nivolumab + ipilimumab
- Adequate hepatic, renal, cardiac and hematologic function
Exclusion
- Prior treatment with cabozantinib (or other mesenchymal-epithelial transition \[MET\] inhibitor) or CB-839
- Receipt of other anticancer therapy within 2-6 weeks, depending on the treatment
- Untreated or active brain metastases or central nervous system cancer, as defined per protocol
- Prior gastric surgery, small bowel resection, or other conditions that may impede adequate absorption of oral study drug
- Known active infection with human immunodeficiency virus (HIV), Hepatitis B or C virus
- Inability to discontinue proton-pump-inhibitor use before randomization
- Patients who are pregnant or lactating
Key Trial Info
Start Date :
April 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2021
Estimated Enrollment :
444 Patients enrolled
Trial Details
Trial ID
NCT03428217
Start Date
April 24 2018
End Date
July 16 2021
Last Update
March 20 2023
Active Locations (133)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Mayo Clinic Cancer Center
Phoenix, Arizona, United States, 85054
3
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
4
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048