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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 21, 2017
First Posted Date  ICMJE May 23, 2017
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
Progression Free Survival (PFS) [ Time Frame: 30 months ]
Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2017)
Progression Free Survival (PFS) [ Time Frame: 18 months ]
Assessed by Independent Review Committee (IRC)-adjudicated PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Change History Complete list of historical versions of study NCT03163667 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
Overall Survival (OS) [ Time Frame: 42 months ]
Assessed by time from randomization to death by any cause
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2017)
  • Overall Survival (OS) of study patients treated with CBE vs. PboE [ Time Frame: 36 months ]
    Assessed by time from randomization to death by any cause
  • PFS of patients treated with CBE vs. PboE [ Time Frame: 18 months ]
    Assessed by investigator per RECIST v1.1
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ENTRATA: CB-839 With Everolimus vs. Placebo With Everolimus in Patients With RCC
Official Title  ICMJE 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)
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Clear Cell Renal Cell Carcinoma
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: CB-839 plus everolimus
    CBE: CB-839 is administered twice daily in combination with standard doses of everolimus
    Intervention: Drug: CB-839 plus everolimus
  • Placebo Comparator: Placebo plus everolimus
    PboE: Placebo is administered twice daily in combination with standard doses of everolimus
    Intervention: Drug: Placebo plus everolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2018)
63
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2017)
252
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03163667
Other Study ID Numbers  ICMJE CX-839-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Calithera Biosciences, Inc
Study Sponsor  ICMJE Calithera Biosciences, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sam Whiting Calithera Biosciences
PRS Account Calithera Biosciences, Inc
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP