NCT03428217

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 444 (actual)
• Sponsor: Calithera Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC).

Conditions

• Advanced Renal Cell Carcinoma
• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	CB-839	Oral glutaminase inhibitor
DRUG	Cabozantinib	Oral receptor tyrosine kinase inhibitor
DRUG	Placebo	Placebo tablets

Timeline

• Start date: 2018-04-24
• Primary completion: 2020-08-31
• Completion: 2021-07-16
• First posted: 2018-02-09
• Last updated: 2023-03-20
• Results posted: 2023-03-20

Locations

133 sites across 8 countries: United States, Australia, France, Germany, Italy, New Zealand, Spain, United Kingdom

Regulatory

• FDA-regulated drug study