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

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ClinicalTrials.gov Identifier: NCT03163667
Recruitment Status : Active, not recruiting
First Posted : May 23, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Calithera Biosciences, Inc

Study Description
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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
Clear Cell Renal Cell Carcinoma Drug: CB-839 plus everolimus Drug: Placebo plus everolimus 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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)
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 : July 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CB-839 plus everolimus
CBE: CB-839 is administered twice daily in combination with standard doses of everolimus
 Drug: 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.
Other Name: Afinitor
Placebo Comparator: Placebo plus everolimus
PboE: Placebo is administered twice daily in combination with standard doses of everolimus
 Drug: Placebo plus everolimus
Placebo is administered as oral tablets twice daily (BID) in combination with standard daily (QD) everolimus in 28 day cycles.
Other Name: Afinitor


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 30 months ]
    Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 42 months ]
    Assessed by time from randomization to death by any cause


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163667


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Sponsors and Collaborators
Calithera Biosciences, Inc
Investigators
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Study Director: Sam Whiting Calithera Biosciences
More Information
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Additional Information:
Calithera Biosciences Company website  This link exits the ClinicalTrials.gov site

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Responsible Party: Calithera Biosciences, Inc
ClinicalTrials.gov Identifier: NCT03163667     History of Changes
Other Study ID Numbers: CX-839-005
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
 Urologic Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents