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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 : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Exelixis

Brief Summary:
The objective of this study is to evaluate the effect of cabozantinib compared with placebo on progression free survival (PFS) and objective response rate (ORR) in subjects with Radioiodine-Refractory Differentiated Thyroid Cancer (DTC) who have progressed after prior VEGFR-Targeted therapy.

Condition or disease Intervention/treatment Phase
Differentiated Thyroid Cancer Drug: Cabozantinib Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
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).
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Cabozantinib
Oral cabozantinib (60 mg) qd
Drug: Cabozantinib
Tablets containing 60-mg or 20-mg cabozantinib or placebo equivalent) once daily orally.
Other Names:
  • XL184
  • Cabometyx®

Placebo Comparator: Placebo
Oral cabozantinib-matched placebo qd
Drug: Placebo
Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally. once daily orally.




Primary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
  2. Measurable disease according to RECIST 1.1
  3. Previously treated with or deemed ineligible for treatment with Iodine- 131 for DTC
  4. Previously treated with at least one of the following VEGFR-targeting TKI agents for DTC: lenvatinib or sorafenib. Note: Up to two prior VEGFR-targeting TKI agents are allowed
  5. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1

Exclusion Criteria:

  1. Prior treatment with any of the following: Cabozantinib; Selective small-molecule 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

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): NCT03690388


Contacts
Contact: Exelixis Clinical Trials 1- 888-393-5494 druginfo@exelixis.com
Contact: Backup or International 650-837-7400

Locations
United States, California
Exelixis Clinical Site #2 Recruiting
Newport Beach, California, United States, 92658
Contact: Exelixis    888-393-5494    druginfo@exelixis.com   
United States, Pennsylvania
Exelixis Clinical Site #1 Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Exelixis    888-393-5494    druginfo@exelixis.com   
Sponsors and Collaborators
Exelixis

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT03690388     History of Changes
Other Study ID Numbers: XL184-311
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Exelixis:
Thyroid cancer, papillary
Papillary thyroid carcinoma
Nonmedullary thyroid carcinoma
Cancer of the thyroid
Thyroid cancer
Follicular thyroid cancer
Thyroid cancer, follicular
Hürthle cell cancer

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms