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Trial record 1 of 1 for:    NCT03428217
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CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma (CANTATA)

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: NCT03428217
Recruitment Status : Active, not recruiting
First Posted : February 9, 2018
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Calithera Biosciences, Inc

Tracking Information
First Submitted Date  ICMJE February 5, 2018
First Posted Date  ICMJE February 9, 2018
Last Update Posted Date October 14, 2019
Actual Study Start Date  ICMJE March 27, 2018
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
Progression Free Survival (PFS) [ Time Frame: 18 months ]
An independent adjudication of radiological assessments will be conducted by Independent Radiology Committee (IRC) reviewing PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
Progression Free Survival (PFS) [ Time Frame: 18 months ]
Assessed by Independent Radiology Committee (IRC)-adjudicated PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
  • Overall Survival (OS) of study patients treated with CB-Cabo vs Pbo-Cabo [ Time Frame: 36 months ]
    Assessed by time from randomization to death by any cause
  • PFS of patients treated with CB-Cabo vs Pbo-Cabo [ Time Frame: 18 months ]
    Assessed by investigator per RECIST v1.1
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)
Brief Summary This clinical trial is a randomized Phase 2 evaluation of CB-839 (telaglenastat) in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma with a clear cell component.
Detailed Description This clinical trial is a randomized Phase 2 evaluation of CB-839 (telaglenastat) in combination with cabozantinib versus placebo with cabozantinib in Renal Cell Carcinoma patients with at least one and not more than 2 prior therapies in the advanced or metastatic setting.
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 1:1 to either CB-839 (telaglenastat) plus cabozantinib or placebo plus cabozantinib
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Participants, care providers, investigators and outcomes assessors are blinded to treatment. Progression free survival (PFS) will be assessed by a blinded Independent Radiology Committee for the primary endpoint of the study.
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Renal Cell Carcinoma
  • Metastatic Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: CB-839
    Oral glutaminase inhibitor
    Other Name: Glutaminase inhibitor
  • Drug: Cabozantinib
    Oral receptor tyrosine kinase inhibitor
    Other Names:
    • Cabometyx
    • Cabometriq
  • Drug: Placebo
    Placebo tablets
    Other Name: Placebo Tablets
Study Arms  ICMJE
  • Experimental: CB-Cabo
    CB-839 orally twice daily + cabozantinib orally once daily
    Interventions:
    • Drug: CB-839
    • Drug: Cabozantinib
  • Placebo Comparator: Pbo-Cabo
    Placebo orally twice daily + cabozantinib orally once daily
    Interventions:
    • Drug: Cabozantinib
    • Drug: Placebo
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
Actual Enrollment  ICMJE
 (submitted: October 11, 2019)
445
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2018)
298
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component
  2. Adult patients
  3. Karnofsky Performance Score (KPS) ≥ 70%
  4. Measurable Disease per RECIST 1.1
  5. 1-2 lines of prior therapy for advanced or metastatic RCC including one anti-angiogenic therapy (any VEGF pathway-targeted agent used either as monotherapy or as a component of a combination regimen) OR the combination regimen of nivolumab + ipilimumab
  6. Adequate hepatic, renal, cardiac and hematologic function

Exclusion Criteria:

  1. Prior treatment with cabozantinib (or other MET inhibitor) or CB-839
  2. Receipt of other anticancer therapy within 2-6 weeks, depending on the treatment
  3. Untreated or active brain metastases or central nervous system cancer, as defined per protocol
  4. Prior gastric surgery, small bowel resection, or other conditions that may impede adequate absorption of oral study drug
  5. Known active infection with HIV, Hepatitis B or C virus
  6. Inability to discontinue proton-pump-inhibitor use before randomization
  7. Patients who are pregnant or lactating
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 Australia,   France,   Germany,   Italy,   New Zealand,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03428217
Other Study ID Numbers  ICMJE CX-839-008
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, M.D., Ph.D. Calithera Biosciences, Inc
PRS Account Calithera Biosciences, Inc
Verification Date October 2019

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