CB-839 With Everolimus vs. Placebo With Everolimus in Participants With Renal Cell Carcinoma (RCC)
NCT ID: NCT03163667
Last Updated: 2022-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2017-09-06
2020-06-01
Brief Summary
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* At least 2 lines of therapy, including at least 1 vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI)
* Radiographic progression of metastatic RCC must have occurred (per investigator assessment) on or after the most recent systemic therapy and within 6 months prior to cycle 1 day 1
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CB-839 + Everolimus
CB-839 is administered as oral tablets twice daily (BID) in combination with standard daily (QD) everolimus in 28 day cycles.
CB-839
oral tablets
everolimus
oral tablets
Placebo + Everolimus
Placebo is administered as oral tablets BID in combination with standard QD everolimus in 28 day cycles.
Placebo
oral tablets
everolimus
oral tablets
Interventions
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Placebo
oral tablets
CB-839
oral tablets
everolimus
oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Estimated Life Expectancy of at least 3 months
* Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component.
* Measurable Disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the Investigator
* Must have received at least two prior lines of systemic therapy, including at least one VEGF TKI (e.g., sunitinib, sorafenib, pazopanib, cabozantinib)
a) Radiographic progression of mRCC must have occurred (per investigator assessment) on or after the most recent systemic therapy and within 6 months prior to Cycle 1 Day 1 (C1D1).
* Prior treatment with other anti-cancer therapies including cytokines, monoclonal antibodies, immunotherapies, and cytotoxic chemotherapy is allowed
Exclusion Criteria
* Receipt of any anticancer therapy within the following windows before randomization:
* TKI therapy within 2 weeks or 5 half-lives, whichever is longer
* Any type of anti-cancer antibody within 4 weeks
* Cytotoxic chemotherapy within 4 weeks
* Investigational therapy within 4 weeks or 5 half-lives, whichever is longer
* Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Patients with clinically relevant ongoing complications from prior radiation therapy are not eligible.
* Unable to receive medications orally (PO) or any condition that may prevent adequate absorption of oral study medication
* Major surgery within 28 days prior to randomization
* Patients with active and/or untreated central nervous system (CNS) cancer are not eligible. Patients with treated brain metastasis must have 1) documented radiographic stability of at least 4 weeks duration demonstrated on baseline contrast-enhanced CNS imaging (eg contrast-enhanced magnetic resonance imaging \[MRI\] of the brain) prior to randomization and 2) must be symptomatically stable and off steroids for at least 2 weeks before randomization.
* Requirement for continued proton pump inhibitor after randomization
* Chronic treatment with corticosteroids or other immunosuppressive agents except (i) inhaled or topical steroids or replacement dose corticosteroids equivalent to ≤ 10 mg prednisone and (ii) patients receiving physiological doses of hydrocortisone for adrenal insufficiency
18 Years
ALL
No
Sponsors
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Calithera Biosciences, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Sam Whiting
Role: STUDY_DIRECTOR
Calithera Biosciences
Locations
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The University of Arizona Cancer Center
Tucson, Arizona, United States
Highlands Oncology Group
Rogers, Arkansas, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, United States
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States
Stanford Cancer Center
Stanford, California, United States
Florida Cancer Specialists- South
Fort Myers, Florida, United States
Florida Cancer Specialists- North
St. Petersburg, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky, United States
Ochsner Clinical Foundation
New Orleans, Louisiana, United States
Anne Arundel Medical Center Oncology and Hematology
Annapolis, Maryland, United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Metro-Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Mercy Clinic Oncology & Hematology
Joplin, Missouri, United States
SCRI HCA Midwest
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists
East Setauket, New York, United States
NYU Winthrop Hospital - Cancer Clinical Trials Oncology/Hematology
Mineola, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Ann B. Barshinger Cancer Institute / Lancaster General Hospital
Lancaster, Pennsylvania, United States
Monongahela Valley Hospital
Monongahela, Pennsylvania, United States
Charleston Hematology Oncology Associates,PA
Charleston, South Carolina, United States
UT/Erlanger Oncology & Hematology
Chattanooga, Tennessee, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Countries
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References
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Aden D, Sureka N, Zaheer S, Chaurasia JK, Zaheer S. Metabolic Reprogramming in Cancer: Implications for Immunosuppressive Microenvironment. Immunology. 2025 Jan;174(1):30-72. doi: 10.1111/imm.13871. Epub 2024 Oct 27.
Lee CH, Motzer R, Emamekhoo H, Matrana M, Percent I, Hsieh JJ, Hussain A, Vaishampayan U, Liu S, McCune S, Patel V, Shaheen M, Bendell J, Fan AC, Gartrell BA, Goodman OB, Nikolinakos PG, Kalebasty AR, Zakharia Y, Zhang Z, Parmar H, Akella L, Orford K, Tannir NM. Telaglenastat plus Everolimus in Advanced Renal Cell Carcinoma: A Randomized, Double-Blinded, Placebo-Controlled, Phase II ENTRATA Trial. Clin Cancer Res. 2022 Aug 2;28(15):3248-3255. doi: 10.1158/1078-0432.CCR-22-0061.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CX-839-005
Identifier Type: -
Identifier Source: org_study_id
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