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ENTRATA: CB-839 With Everolimus vs. Placebo With Everolimus in Patients With Renal Cell Carcinoma (RCC)

Sponsor
Calithera Biosciences, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT03163667
Collaborator
(none)
63
Enrollment
38
Locations
2
Arms
32.1
Actual Duration (Months)
1.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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)

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a double blinded placebo-controlled study where patients will be randomized 2:1 to either CB-839 plus everolimus (CBE) or placebo plus everolimus (PboE)This is a double blinded placebo-controlled study where patients will be randomized 2:1 to either CB-839 plus everolimus (CBE) or placebo plus everolimus (PboE)
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blinded, placebo-controlled
Primary Purpose:
Treatment
Official Title:
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)
Actual Study Start Date :
Sep 6, 2017
Actual Primary Completion Date :
Apr 26, 2019
Actual Study Completion Date :
May 11, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CB-839 plus everolimus

CB-839 is administered as oral tablets twice daily (BID) in combination with standard daily (QD) everolimus in 28 day cycles.

Drug: CB-839
oral tablets
Other Names:
  • telaglenastat

    • Drug: everolimus
    oral tablets
    Other Names:
  • Afinitor

    		•
    Placebo Comparator: Placebo plus everolimus

    Placebo is administered as oral tablets BID in combination with standard QD everolimus in 28 day cycles.

    Drug: Placebo
    oral tablets

    Drug: everolimus
    oral tablets
    Other Names:
  • Afinitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) [30 months]

      Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Secondary Outcome Measures

    1. Overall Survival (OS) [42 months]

      Assessed by time from randomization to death by any cause

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    1. 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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Calithera Biosciences, Inc

    Investigators

    • Study Director: Sam Whiting, Calithera Biosciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Calithera Biosciences, Inc
    ClinicalTrials.gov Identifier:
    NCT03163667
    Other Study ID Numbers:
    • CX-839-005
    First Posted:
    May 23, 2017
    Last Update Posted:
    Aug 19, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Calithera Biosciences, Inc
    advanced, metastatic RCC
    RCC
    CB-839
    Everolimus
    CBE
    Glutaminase Inhibitor
    Glutaminase
    Tumor Metabolism
    Glutamine
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell
    Everolimus

    Study Results

    No Results Posted as of Aug 19, 2021