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CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma (CANTATA)

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ClinicalTrials.gov Identifier: NCT03428217
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Calithera Biosciences, Inc

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.

Condition or disease Intervention/treatment Phase
Advanced Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Drug: CB-839 Drug: Cabozantinib Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 416 participants
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
Official Title: 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)
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CB-Cabo
CB-839 orally twice daily + cabozantinib orally once daily
Drug: CB-839
Oral glutaminase inhibitor
Other Name: Glutaminase inhibitor

Drug: Cabozantinib
Oral receptor tyrosine kinase inhibitor
Other Names:
  • Cabometyx
  • Cabometriq

Placebo Comparator: Pbo-Cabo
Placebo orally twice daily + cabozantinib orally once daily
Drug: Cabozantinib
Oral receptor tyrosine kinase inhibitor
Other Names:
  • Cabometyx
  • Cabometriq

Drug: Placebo
Placebo tablets
Other Name: Placebo Tablets




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. PFS of patients treated with CB-Cabo vs Pbo-Cabo [ Time Frame: 18 months ]
    Assessed by investigator per RECIST v1.1



Information from the National Library of Medicine

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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:

  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

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): NCT03428217


Contacts
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Contact: Clinical Trials Administrator 650-870-1000 clinicaltrials@calithera.com
Contact: Clinical Admin 650-870-1000 clinicaltrials@calithera.com

  Show 104 Study Locations
Sponsors and Collaborators
Calithera Biosciences, Inc
Investigators
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Study Director: Sam Whiting, M.D., Ph.D. Calithera Biosciences, Inc

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Responsible Party: Calithera Biosciences, Inc
ClinicalTrials.gov Identifier: NCT03428217     History of Changes
Other Study ID Numbers: CX-839-008
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
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:
Tumor Metabolism
RCC
Glutaminase Inhibitor
CB-839
CANTATA
TKI
Tyrosine Kinase Inhibitor
cabozantinib
Cabometyx
Cometriq
glutaminase
glutamine
renal cell
clear cell
kidney cancer
cMET
MET
HGFR
telaglenastat

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