Description:
This clinical trial is a randomized Phase 2 evaluation of CB-839 (telaglenastat) in
combination with cabozantinib versus placebo with cabozantinib in patients with advanced or
metastatic Renal Cell Carcinoma with a clear cell component.
Title
- Brief Title: CB-839 With Cabozantinib vs. Placebo With Cabozantinib in Patients With Metastatic Renal Cell Carcinoma
- Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) - CANTATA
Clinical Trial IDs
- ORG STUDY ID:
CX-839-008
- NCT ID:
NCT03428217
Conditions
- Advanced Renal Cell Carcinoma
- Metastatic Renal Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
CB-839 | Glutaminase inhibitor | CB-Cabo |
Cabozantinib | Cabometyx, Cabometriq | CB-Cabo |
Placebo | Placebo Tablets | Pbo-Cabo |
Purpose
This study is a randomized Phase 2 evaluation of CB-839 in combination with cabozantinib
versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell
Carcinoma.
Detailed Description
This study is a randomized Phase 2 evaluation of CB-839 in combination with cabozantinib
versus placebo with cabozantinib in Renal Cell Carcinoma patients with at least one and not
more than 2 prior therapies in the advanced or metastatic setting.
Trial Arms
Name | Type | Description | Interventions |
---|
CB-Cabo | Experimental | CB-839 orally twice daily + cabozantinib orally once daily | |
Pbo-Cabo | Placebo Comparator | Placebo orally twice daily + cabozantinib orally once daily | |
Eligibility Criteria
Inclusion Criteria:
- Documented histological or cytological diagnosis of renal cell carcinoma with a
clear-cell component
- Adult patients
- Karnofsky Performance Score (KPS) ≥ 70%
- Measurable Disease per RECIST 1.1
- 1-2 lines of prior therapy for advanced or metastatic RCC including at least one
antiangiogenic therapy or nivolumab + ipilimumab
- Adequate hepatic, renal, cardiac and hematologic function
Exclusion Criteria:
- Prior treatment with cabozantinib (or other 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 HIV, Hepatitis B or C virus
- Requirement for continued proton pump inhibitor after randomization
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression Free Survival (PFS) |
Time Frame: | 18 months |
Safety Issue: | |
Description: | Assessed by Independent Radiology Committee (IRC)-adjudicated PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
Secondary Outcome Measures
Measure: | Overall Survival (OS) of study patients treated with CB-Cabo vs Pbo-Cabo |
Time Frame: | 36 months |
Safety Issue: | |
Description: | Assessed by time from randomization to death by any cause |
Measure: | PFS of patients treated with CB-Cabo vs Pbo-Cabo |
Time Frame: | 18 months |
Safety Issue: | |
Description: | Assessed by investigator per RECIST v1.1 |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Calithera Biosciences, Inc |
Trial Keywords
- Tumor Metabolism
- RCC
- Glutaminase Inhibitor
- CB-839
- CANTATA
- TKI
- Tyrosine Kinase Inhibitor
- cabozantinib
- Cabometyx
- Cometriq
- glutaminase
- glutamine
- renal cell
- clear cell
- kidney cancer
- cMET
- MET
- HGFR
Last Updated
April 3, 2018