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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03428217
Registration number
NCT03428217
Ethics application status
Date submitted
5/02/2018
Date registered
9/02/2018
Date last updated
20/03/2023
Titles & IDs
Public title
CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
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Scientific 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)
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Secondary ID [1]
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CX-839-008
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Universal Trial Number (UTN)
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Trial acronym
CANTATA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Renal Cell Carcinoma
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Metastatic Renal Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CB-839
Treatment: Drugs - Cabozantinib
Treatment: Drugs - Placebo
Placebo Comparator: Pbo-Cabo - Placebo twice daily (BID) + cabozantinib (60 mg once daily [QD]) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or unacceptable toxicity, whichever occurred first.
Experimental: CB-Cabo - CB-839 800 mg BID + cabozantinib (60 mg QD) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per RECIST v1.1 or unacceptable toxicity, whichever occurred first.
Treatment: Drugs: CB-839
Oral glutaminase inhibitor
Treatment: Drugs: Cabozantinib
Oral receptor tyrosine kinase inhibitor
Treatment: Drugs: Placebo
Placebo tablets
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS) as Assessed by the Independent Radiology Committee (IRC)
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Assessment method [1]
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PFS is defined as the time from randomization to the occurrence of disease progression as assessed by the IRC using RECIST v1.1 or death from any cause, whichever occurs first. Subjects not experiencing disease progression or death at the time of analysis of PFS will be censored at the date of the last evaluable radiographic disease assessment. RECIST v1.1 criteria:
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
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Timepoint [1]
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Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for PFS was 22.14 months.
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from randomization to death due to any cause. Estimated from Kaplan-Meier methodology. 95% confidence interval (CI) based on Brookmeyer-Crowley methodology.
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Timepoint [1]
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Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for OS was 25.86 months.
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Secondary outcome [2]
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PFS as Assessed by the Investigator
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Assessment method [2]
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PFS is defined as the time from randomization to the occurrence of disease progression as assessed by the IRC using RECIST v1.1 or death from any cause, whichever occurs first. Subjects not experiencing disease progression or death at the time of analysis of PFS will be censored at the date of the last evaluable radiographic disease assessment. RECIST v1.1 criteria:
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
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Timepoint [2]
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Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for PFS was 22.64 months.
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Eligibility
Key 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 Response Evaluation Criteria in Solid Tumors version 1.1
(RECIST v1.1)
5. 1-2 lines of prior therapy for advanced or metastatic renal cell carcinoma (RCC)
including one anti-angiogenic therapy (any vascular endothelial growth factor [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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Prior treatment with cabozantinib (or other mesenchymal-epithelial transition [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 human immunodeficiency virus (HIV), Hepatitis B or C virus
6. Inability to discontinue proton-pump-inhibitor use before randomization
7. Patients who are pregnant or lactating
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/04/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/07/2021
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Sample size
Target
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Accrual to date
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Final
444
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Southern Highlands Private Hospital (Cancer Centre) - Bowral
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Chris O'Brien Lifehouse - Camperdown
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MacQuarie University Hospital - North Ryde
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Tweed Hospital - Tweed Heads
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Pindara Private Hospital - Benowa
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Cairns Hospital - Cairns
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Mater Misericordiae Limited - Division of Cancer Services - South Brisbane
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Ballarat Health Services - Ballarat
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Hollywood Private Hospital - Nedlands
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2576 - Bowral
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2050 - Camperdown
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2109 - North Ryde
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2170 - Sydney
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2485 - Tweed Heads
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4217 - Benowa
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4870 - Cairns
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4101 - South Brisbane
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4102 - Woolloongabba
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3350 - Ballarat
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3199 - Frankston
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3144 - Malvern
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3630 - Shepparton
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6009 - Nedlands
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Calithera Biosciences, Inc
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Ethics approval
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Summary
Brief summary
Tthe primary objective of this study is to compare blinded Independent Radiology Committee
(IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 +
cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic
clear-cell RCC (ccRCC).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03428217
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Sam Whiting, M.D., Ph.D.
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Calithera Biosciences, Inc
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03428217
Download to PDF