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 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.

Official Title

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) - CANTATA

Details

This study is a randomized Phase 2 evaluation of CB-839 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 CarcinomaMetastatic Renal Cell CarcinomaTumor MetabolismRCCGlutaminase InhibitorCB-839CANTATATKITyrosine Kinase InhibitorcabozantinibCabometyxCometriqglutaminaseglutaminerenal cellclear cellkidney cancercMETMETHGFRCarcinomaCarcinoma, Renal CellCB-CaboPbo-Cabo

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UC San Diego Moores Cancer Centeraccepting new patients
    San DiegoCalifornia92093United States
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Instituteaccepting new patients
    Los AngelesCalifornia90048United States

Lead Scientist

  • Rana McKay
    Authored (or co-authored) 55 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