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NCT Number: NCT03690388

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

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 vascular endothelial growth factor receptor (VEGFR)-Targeted therapy.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Differentiated Thyroid Cancer Adenocarcinoma Adenocarcinoma, Follicular Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms Thyroid cancer, follicular

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Exelixis Clinical Site #96, Pergamino, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Previously treated with or deemed ineligible for treatment with Iodine- 131 for differentiated thyroid cancer (DTC)
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Exclusion criteria

  • 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)
  • 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
  • Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization
  • Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization.
  • Known brain metastases or cranial epidural disease unless adequately treated

Treatment and study plan

Cabozantinib

Drug

Tablets containing 60-mg or 20-mg cabozantinib once daily orally.

Other names: XL184, Cabometyx®

Placebo

Drug

Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.

Primary outcomes

  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 blinded independent central review (BIRC) or death due to any cause.

    Time to the earlier of either radiographic progressive disease (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 complete response (CR) or confirmed partial response (PR) per BIRC per RECIST 1.1.

    Proportion of subjects with the best overall response of complete response (CR) or partial response (PR).

Sponsors and collaborators

Lead sponsor

Exelixis

Industry

Collaborators

  • Ipsen

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2026
First posted
Oct 1, 2018
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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