A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior VEGFR-targeted Therapy
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|ClinicalTrials.gov Identifier: NCT03690388|
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : September 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Differentiated Thyroid Cancer||Drug: Cabozantinib Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of cabozantinib in subjects with RAI-refractory DTC after prior VEGFR-TKI therapy. Cabozantinib-matched placebo will be given in the control arm to blind (mask) study treatment. Approximately 300 eligible subjects will be randomized in a 2:1 ratio to receive either cabozantinib or placebo. After the primary efficacy endpoints have been analyzed and sufficient data have been collected to adequately evaluate all study endpoints to establish, for regulatory purposes, the safety and efficacy profile of the experimental drug within this study, the study will transition to an open label Maintenance Phase.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Study treatment assignment will be unknown to the subjects, investigators, study centers, Sponsor, and any Contract Research Organization affiliated with the study other than those authorized to access treatment assignment for regulatory safety reporting and submission processes, IRT system administration, and drug supply management. Cabozantinib-matched placebo will be packaged and color-, size-, and shape-matched to be indistinguishable from cabozantinib. Individual study treatment assignment will be unblinded and information provided to the Investigators upon request for subjects with radiographic PD per RECIST 1.1 confirmed by the blinded independent radiology committee (BIRC).|
|Official 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 VEGFR-Targeted Therapy|
|Actual Study Start Date :||October 5, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2022|
Oral cabozantinib (60 mg) qd
Tablets containing 60-mg or 20-mg cabozantinib or placebo equivalent) once daily orally.
Placebo Comparator: Placebo
Oral cabozantinib-matched placebo qd
Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally. once daily orally.
- Progression Free Survival (PFS) [ Time Frame: 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 BIRC or death due to any cause. ]Time to the earlier of either radiographic PD or death from any cause.
- Objective Response Rate (ORR) [ Time Frame: Six months after 100 subjects are randomized. Time from randomization to best overall response of confirmed CR or confirmed PR per BIRC per RECIST 1.1. ]Proportion of subjects with the best overall response of complete response (CR) or partial response (PR).
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): NCT03690388
|Contact: Exelixis Clinical Trials||1- email@example.com|
|Contact: Backup or International||650-837-7400|
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