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: CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
- Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial 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)
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 | telaglenastat | CB-Cabo |
Cabozantinib | Cabometyx, Cabometriq | CB-Cabo |
Placebo | | Pbo-Cabo |
Purpose
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.
Detailed Description
This clinical trial is a randomized Phase 2 evaluation of CB-839 (telaglenastat) 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:
1. Documented histological or cytological diagnosis of renal cell carcinoma with a
clear-cell component
2. Adult patients
3. Karnofsky Performance Score (KPS) ≥ 70%
4. Measurable Disease per RECIST 1.1
5. 1-2 lines of prior therapy for advanced or metastatic RCC including one
anti-angiogenic therapy (any VEGF pathway-targeted agent used either as monotherapy or
as a component of a combination regimen) OR the combination regimen of nivolumab +
ipilimumab
6. Adequate hepatic, renal, cardiac and hematologic function
Exclusion Criteria:
1. Prior treatment with cabozantinib (or other MET inhibitor) or CB-839
2. Receipt of other anticancer therapy within 2-6 weeks, depending on the treatment
3. Untreated or active brain metastases or central nervous system cancer, as defined per
protocol
4. Prior gastric surgery, small bowel resection, or other conditions that may impede
adequate absorption of oral study drug
5. Known active infection with HIV, Hepatitis B or C virus
6. Inability to discontinue proton-pump-inhibitor use before randomization
7. Patients who are pregnant or lactating
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: | An independent adjudication of radiological assessments will be conducted by Independent Radiology Committee (IRC) reviewing 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: | Completed |
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
- telaglenastat
Last Updated
August 23, 2021