A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Everolimus (CBE) vs. Placebo With Everolimus (PboE) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)

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ENTRATA- A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Everolimus (CBE) vs. Placebo With Everolimus (PboE) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)

Condition: Clear Cell Renal Cell Carcinoma

Intervention:

  • Drug: CB-839 plus everolimus
  • Drug: Placebo plus everolimus

Purpose: Phase 2 Study Comparing CB-839 in Combination with Everolimus (CBE) vs. Placebo with Everolimus (PboE) in Patients with Advanced or Metastatic RCC

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03163667

Sponsor: Calithera Biosciences, Inc

Primary Outcome Measures:

  • Measure: Progression Free Survival (PFS)
  • Time Frame: 30 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall Survival (OS)
  • Time Frame: 42 months
  • Safety Issue:

Estimated Enrollment: 63

Study Start Date: July 1, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Karnofsky Performance Score (KPS) ≥ 70%
  • Estimated Life Expectancy of at least 3 mo
  • Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component.
  • Measurable Disease per RECIST 1.1 as determined by the Investigator
  • Must have received at least two prior lines of systemic therapy, including at least one VEGFR-targeting 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 mo prior to C1D1.
  • Prior treatment with other anti-cancer therapies including cytokines, monoclonal antibodies, immunotherapies, and cytotoxic chemotherapy is allowed

Exclusion Criteria:

  • Prior treatment with mTOR inhibitors (everolimus or temsirolimus) or CB-839
  • 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 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 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

Locations:

  • The University of Arizona Cancer Center
  • Tucson Arizona 85724 United States
  • Highlands Oncology Group
  • Rogers Arkansas 72758 United States
  • Los Angeles Hematology Oncology Medical Group
  • Los Angeles California 90017 United States
  • UCLA Department of Medicine – Hematology/Oncology
  • Los Angeles California 90095 United States
  • Stanford Cancer Center
  • Stanford California 94305 United States
  • Florida Cancer Specialists- South
  • Fort Myers Florida 33901 United States
  • Florida Cancer Specialists- North
  • Saint Petersburg Florida 33705 United States
  • University Cancer & Blood Center, LLC
  • Athens Georgia 30607 United States
  • Northwest Georgia Oncology Centers, P.C.
  • Marietta Georgia 30060 United States
  • St. Luke’s Mountain States Tumor Institute
  • Boise Idaho 83712 United States
  • Northwestern University
  • Chicago Illinois 60611 United States
  • Parkview Research Center
  • Fort Wayne Indiana 46845 United States
  • University of Iowa Hospitals and Clinics
  • Iowa City Iowa 52242 United States
  • Norton Cancer Institute, Norton Healthcare Pavilion
  • Louisville Kentucky 40202 United States
  • Ochsner Clinical Foundation
  • New Orleans Louisiana 70121 United States
  • Anne Arundel Medical Center Oncology and Hematology
  • Annapolis Maryland 21401 United States
  • University of Maryland, Greenebaum Comprehensive Cancer Center
  • Baltimore Maryland 21201 United States
  • Metro-Minnesota Community Oncology Research Consortium
  • Saint Louis Park Minnesota 55416 United States
  • Mercy Clinic Oncology & Hematology
  • Joplin Missouri 64804 United States
  • SCRI HCA Midwest
  • Kansas City Missouri 64132 United States
  • Washington University School of Medicine
  • Saint Louis Missouri 63110 United States
  • St. Vincent Frontier Cancer Center
  • Billings Montana 59102 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 89148 United States
  • Montefiore Medical Center
  • Bronx New York 10461 United States
  • North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists
  • East Setauket New York 11733 United States
  • NYU Winthrop Hospital – Cancer Clinical Trials Oncology/Hematology
  • Mineola New York 11501 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • SUNY Upstate Medical University
  • Syracuse New York 13210 United States
  • University of Cincinnati Medical Center
  • Cincinnati Ohio 45219 United States
  • Ann B. Barshinger Cancer Institute / Lancaster General Hospital
  • Lancaster Pennsylvania 17604 United States
  • Monongahela Valley Hospital
  • Monongahela Pennsylvania 15063 United States
  • Charleston Hematology Oncology Associates,PA
  • Charleston South Carolina 29414 United States
  • UT/Erlanger Oncology & Hematology
  • Chattanooga Tennessee 37403 United States
  • Sarah Cannon Research Institute – Tennessee Oncology
  • Nashville Tennessee 37203 United States
  • The University of Texas MD Anderson Cancer Center
  • Houston Texas 77030 United States
  • Utah Cancer Specialists
  • Salt Lake City Utah 84106 United States
  • Wenatchee Valley Hospital and Clinics
  • Wenatchee Washington 98801 United States
  • University of Wisconsin Carbone Cancer Center
  • Madison Wisconsin 53705 United States

View trial on ClinicalTrials.gov

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