CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 444 enrolled
Drug / intervention
CB-839 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03428217
NCT03428217Phase 2Completed

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)

Calithera Biosciences, Inc·interventional·Posted Feb 9, 2018·Updated Mar 20, 2023

In Brief

A Phase 2 clinical trial evaluating CB-839, Cabozantinib, and 1 other intervention for Advanced Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma. Completed, enrolled 444 participants across 133 sites in 8 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, France, Germany, Italy, New Zealand, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 9, 2018
Enrollment StartApr 24, 2018
Primary CompletionAug 31, 2020
Study CompletionJul 16, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.4 years ago

Interventions

CB-839drug

Oral glutaminase inhibitor

Cabozantinibdrug

Oral receptor tyrosine kinase inhibitor

Placebodrug

Placebo tablets