A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior VEGFR-targeted Therapy



Status:Recruiting
Conditions:Cancer, Cancer, Endocrine
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:16 - Any
Updated:4/6/2019
Start Date:October 5, 2018
End Date:December 2022
Contact:Exelixis Clinical Trials
Email:druginfo@exelixis.com
Phone:1- 888-393-5494

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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

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.


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
We found this trial at
10
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Philadelphia, Pennsylvania 19107
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Aurora, Colorado 80045
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Newport Beach, California 92658
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Stanford, California 94305
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Tampa, Florida 33612
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Torrance, California 90502
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Washington, District of Columbia 20010
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