Clinical Trials /

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

NCT03690388

Description:

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.

Related Conditions:
  • Well-Differentiated Thyroid Gland Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: XL184-311
  • NCT ID: NCT03690388

Conditions

  • Differentiated Thyroid Cancer

Interventions

DrugSynonymsArms
CabozantinibXL184, Cabometyx®Cabozantinib
PlaceboPlacebo

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
CabozantinibExperimentalOral cabozantinib (60 mg) qd
  • Cabozantinib
PlaceboPlacebo ComparatorOral cabozantinib-matched placebo qd
  • Placebo

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:16 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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.
Safety Issue:
Description:Time to the earlier of either radiographic PD or death from any cause.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Exelixis

Trial Keywords

  • Thyroid cancer, papillary
  • Papillary thyroid carcinoma
  • Nonmedullary thyroid carcinoma
  • Cancer of the thyroid
  • Thyroid cancer
  • Follicular thyroid cancer
  • Thyroid cancer, follicular
  • Hürthle cell cancer

Last Updated