CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
Placebo +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/NCT03163667
NCT03163667Phase 2Completed

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Everolimus (CBE) vs. Placebo With Everolimus (PboE) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)

Calithera Biosciences, Inc·interventional·Posted May 23, 2017·Updated Sep 15, 2022

In Brief

A Phase 2 clinical trial evaluating Placebo, CB-839, and 1 other intervention for Clear Cell Renal Cell Carcinoma. Completed, enrolled 69 participants across 38 sites.

Detailed Summary

The primary objective of this study is to compare the progression-free survival (PFS) of participants treated with telaglenastat and everolimus versus placebo and everolimus for advanced or metastatic clear cell renal cell carcinoma (ccRCC) previously treated with the following: * At least 2 lines of therapy, including at least 1 vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI) * Radiographic progression of metastatic RCC must have occurred (per investigator assessment) on or after the most recent systemic therapy and within 6 months prior to cycle 1 day 1

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 23, 2017
Enrollment StartSep 6, 2017
Primary CompletionApr 26, 2019
Study CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.1 years ago

Interventions

Placebodrug

oral tablets

CB-839drug

oral tablets

everolimusdrug

oral tablets