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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03428217




Registration number
NCT03428217
Ethics application status
Date submitted
5/02/2018
Date registered
5/02/2018
Date last updated
11/12/2018

Titles & IDs
Public title
CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study 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) - CANTATA
Secondary ID [1] 0 0
CX-839-008
Universal Trial Number (UTN)
Trial acronym
CANTATA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Renal Cell Carcinoma 0 0
Metastatic Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CB-839
Treatment: Drugs - Cabozantinib
Treatment: Drugs - Placebo

Experimental: CB-Cabo - CB-839 orally twice daily + cabozantinib orally once daily

Placebo Comparator: Pbo-Cabo - Placebo orally twice daily + cabozantinib orally once daily


Treatment: Drugs: CB-839
Oral glutaminase inhibitor

Treatment: Drugs: Cabozantinib
Oral receptor tyrosine kinase inhibitor

Treatment: Drugs: Placebo
Placebo tablets

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) - Assessed by Independent Radiology Committee (IRC)-adjudicated PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Overall Survival (OS) of study patients treated with CB-Cabo vs Pbo-Cabo - Assessed by time from randomization to death by any cause
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
PFS of patients treated with CB-Cabo vs Pbo-Cabo - Assessed by investigator per RECIST v1.1
Timepoint [2] 0 0
18 months

Eligibility
Key inclusion criteria
- Documented histological or cytological diagnosis of renal cell carcinoma with a
clear-cell component

- Adult patients

- Karnofsky Performance Score (KPS) = 70%

- Measurable Disease per RECIST 1.1

- 1-2 lines of prior therapy for advanced or metastatic RCC including at least one
antiangiogenic therapy or nivolumab + ipilimumab

- Adequate hepatic, renal, cardiac and hematologic function
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment with cabozantinib (or other MET inhibitor) or CB-839

- Receipt of other anticancer therapy within 2 - 6 weeks, depending on the treatment

- Untreated or active brain metastases or central nervous system cancer, as defined per
protocol

- Prior gastric surgery, small bowel resection, or other conditions that may impede
adequate absorption of oral study drug

- Known active infection with HIV, Hepatitis B or C virus

- Requirement for continued proton pump inhibitor after randomization

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Southern Highlands Private Hospital (Cancer Centre) - Bowral
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
MacQuarie University Hospital - North Ryde
Recruitment hospital [4] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [5] 0 0
Tweed Hospital - Tweed Heads
Recruitment hospital [6] 0 0
Cairns Hospital - Cairns
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 0 0
Ballarat Health Services - Ballarat
Recruitment hospital [9] 0 0
Peninsula Private Hospital - Frankston
Recruitment hospital [10] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [11] 0 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2576 - Bowral
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2109 - North Ryde
Recruitment postcode(s) [4] 0 0
2170 - Sydney
Recruitment postcode(s) [5] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [6] 0 0
4870 - Cairns
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
3350 - Ballarat
Recruitment postcode(s) [9] 0 0
3199 - Frankston
Recruitment postcode(s) [10] 0 0
3144 - Malvern
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Mexico
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
United States of America
State/province [25] 0 0
Wisconsin
Country [26] 0 0
New Zealand
State/province [26] 0 0
Grafton
Country [27] 0 0
New Zealand
State/province [27] 0 0
South Island
Country [28] 0 0
New Zealand
State/province [28] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Calithera Biosciences, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is a randomized Phase 2 evaluation of CB-839 in combination with cabozantinib
versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell
Carcinoma.
Trial website
https://clinicaltrials.gov/show/NCT03428217
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bridget O'Keeffe, PhD
Address 0 0
Calithera Biosciences, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Administrator
Address 0 0
Country 0 0
Phone 0 0
650-870-1000
Fax 0 0
Email 0 0
clinicaltrials@calithera.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable