Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion
Rana McKay

Description

Summary

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.

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)

Details

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.

Keywords

Advanced Renal Cell Carcinoma Metastatic Renal Cell Carcinoma 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 Carcinoma Carcinoma, Renal Cell CB-Cabo Pbo-Cabo

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    San Diego California 92093 United States
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute accepting new patients
    Los Angeles California 90048 United States

Lead Scientist

  • Rana McKay
    Assistant Clinical Professor, Medicine. Authored (or co-authored) 60 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Calithera Biosciences, Inc
ID
NCT03428217
Phase
Phase 2
Study Type
Interventional
Last Updated