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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:March 27, 2018
End Date:September 30, 2022
Contact:Clinical Trials Administrator
Email:clinicaltrials@calithera.com
Phone:650-870-1000

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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)

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.

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.

Inclusion Criteria:

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

Exclusion Criteria:

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
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Hattiesburg, Mississippi 39401
Principal Investigator: John Hrom, MD
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185 Cambridge Street
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330 Brookline Ave
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5801 South Ellis Avenue
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3840 Broadway
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1211 Medical Center Dr
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500 S State St
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Atlanta, Georgia 30322
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Augusta, Georgia 30912
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450 Brookline Ave
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Bowral, New South Wales
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Buffalo, New York 14263
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171 Ashley Avenue
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303 East Superior Street
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1515 Holcombe Blvd
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