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Active Clinical Trials

CANTATA: CB-839 With Cabozantinib vs. Placebo With Cabozantinib in Patients With Metastatic Renal Cell Carcinoma (CANTATA)

Active NCT:
03428217
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
Calithera Biosciences, Inc.
Contact: 

For more information, please contact Andrea Fabian, RN by telephone at 412-359-6452 or email at Andrea.Fabian@ahn.org or Christy Milburn by telephone at 412-359-8379 or email Christy.Milburn@ahn.org.

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)

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.

Ages Eligible for Study:  18 Years and older   (Adult, Senior)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

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