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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03690388




Registration number
NCT03690388
Ethics application status
Date submitted
26/09/2018
Date registered
1/10/2018

Titles & IDs
Public title
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects With Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
Secondary ID [1] 0 0
XL184-311
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Differentiated Thyroid Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Thyroid
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

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

Experimental: Cabozantinib - cabozantinib (60 mg) once daily orally (qd)

Placebo comparator: Placebo - placebo once daily orally (qd)


Treatment: Drugs: Cabozantinib
Tablets containing 60-mg or 20-mg cabozantinib once daily orally.

Treatment: Drugs: Placebo
Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately twenty months after the first subject is randomized. Time from randomization to the earlier of the following events: radiographic PD as determined by the blinded independent central review (BIRC) or death due to any cause.
Primary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Six months after 100 subjects are randomized. Time from randomization to best overall response of confirmed complete response (CR) or confirmed partial response (PR) per BIRC per RECIST 1.1.

Eligibility
Key inclusion criteria
1. Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
2. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
3. Previously treated with or deemed ineligible for treatment with Iodine- 131 for differentiated thyroid cancer (DTC)
4. Previously treated with at least one of the following vascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitor (TKI) agents for DTC: lenvatinib or sorafenib. Note: Up to two prior VEGFR-targeting TKI agents are allowed
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior treatment with any of the following: Cabozantinib; Selective small-molecule v-raf murine sarcoma viral oncogene homolog B1 (BRAF) kinase inhibitor; More than 2 VEGFR-targeting TKI agents; More than 1 immune checkpoint inhibitor therapy; 1 systemic chemotherapy regimen (given as single agent or in combination with another chemotherapy agent)
2. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives of the agent, whichever is longer, before randomization
3. Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization
4. Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization.
5. Known brain metastases or cranial epidural disease unless adequately treated

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
187
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Exelixis Clinical Site #17 - St. Leonards
Recruitment hospital [2] 0 0
Exelixis Clinical Site #25 - Waratah
Recruitment hospital [3] 0 0
Exelixis Clinical Site #86 - Bedford Park
Recruitment hospital [4] 0 0
Exelixis Clinical Site #24 - Melbourne
Recruitment hospital [5] 0 0
Exelixis Clinical Site #12 - Herston
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment outside Australia
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United States of America
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Illinois
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Kentucky
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Massachusetts
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Michigan
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Missouri
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Nebraska
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New Jersey
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Washington
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Córdoba
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Austria
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Salzburg
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Vienna
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Anderlecht
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Belgium
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Brussels
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Edegem
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Gent
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Ontario
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Osijek
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Zagreb
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Brno
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Olomouc
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Besançon
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Bonn
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Petah tikva
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Catania
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CT
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Forlì - Cesena
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GE
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Milano
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PI
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TO
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Slaskie
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Wielkopolskie
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Romania
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Cluj
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Romania
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Dolj
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Romania
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Timis
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Romania
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Bucuresti
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Russian Federation
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Kaluzhiskiy Region
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Russian Federation
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Kursk Region
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Russian Federation
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Tyumen Region
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Moscow
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Omsk
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Saint Petersburg
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Samara
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Yaroslavl
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Spain
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Barcelona
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Madrid
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Spain
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Málaga
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Taiwan
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Tainan
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Songkla
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United Kingdom
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England
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United Kingdom
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Scotland
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Wales
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United Kingdom
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Manchester
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United Kingdom
State/province [115] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Exelixis
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ipsen
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03690388