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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    416
  • sponsor
    Calithera Biosciences, Inc
Updated on 18 August 2019
Investigator
Clinical Administrator
Primary Contact
MacQuarie University Hospital (1.3 mi away) Contact
+138 other location
measurable disease
vegf
cabozantinib
nivolumab
ipilimumab
vascular endothelial growth factor

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.

Description

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.

Details
Treatment Placebo, Cabozantinib, CB-839
Clinical Study IdentifierNCT03428217
SponsorCalithera Biosciences, Inc
Last Modified on18 August 2019

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Metastatic Renal Cell Carcinoma or Advanced Renal Cell Carcinoma?
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 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
Adequate hepatic, renal, cardiac and hematologic function

Exclusion Criteria

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
Inability to discontinue proton-pump-inhibitor use before randomization
Patients who are pregnant or lactating
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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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