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
We found this trial at
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Boise, Idaho 83712
Principal Investigator: Rafael Arteta-Bulos, MD
Phone: 208-381-2774
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185 Cambridge Street
Boston, Massachusetts 02114
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Principal Investigator: Richard Lee, M.D., Ph.D.
Phone: 617-724-4000
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: David F McDermott, MD
Phone: 617-975-7412
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Walter Stadler, MD
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: James Reeves, MD
Phone: 239-274-9930
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Nancy Davis, MD
Phone: 615-875-7981
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
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Phone: 800-865-1125
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30322
Principal Investigator: Bradley Carthon, MD
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Augusta, Georgia 30912
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Baltimore, Maryland 20742
(301) 405-1000
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Phone: 410-328-8739
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Bradley McGregor, M.D., Ph.D.
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Bowral, New South Wales
Principal Investigator: Stephen Della-Fiorentina, MD
Phone: +61 02 4862 9469
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Buffalo, New York 14263
Principal Investigator: Saby George, MD
Phone: 716-845-8313
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Phone: 843-792-9321
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Charlotte, North Carolina 28211
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303 East Superior Street
Chicago, Illinois 60611
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Colorado Springs, Colorado 80907
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Detroit, Michigan 48201
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East Setauket, New York 11733
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Farmington, New Mexico 87401
Principal Investigator: Sardar Imam, MD
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Fort Worth, Texas 76104
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Germantown, Tennessee 38138
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Hattiesburg, Mississippi 39401
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1 Salt Creek Lane
Hinsdale, Illinois 60521
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Nizar Tannir, MD
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2316 East Meyer Boulevard
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Kennewick, Washington 99336
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
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1475 NW 12th Ave
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3322 West End Avenue
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3800 Reservoir Rd NW
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