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

Sponsor: Exelixis

Sponsor score: 40

ClinicalTrials ID:NCT03690388

This study assesses cabozantinib's impact on PFS and ORR in patients with radioiodine-refractory DTC post-VEGFR therapy. Eligible participants must have confirmed DTC, measurable disease per RECIST 1.1, prior iodine-131 treatment, and previous VEGFR-TKI therapy. Interventions include daily oral cabozantinib or placebo tablets. Participants must have an ECOG performance status of 0 or 1.

Patient Parameters

Program Overview

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.

Eligibility Criteria

Inclusion Criteria

  1. Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
  2. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  3. Previously treated with or deemed ineligible for treatment with Iodine- 131 for differentiated thyroid cancer (DTC)
  4. 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
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Exclusion Criteria

  1. 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)
  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

Locations

FACILITYZIPCITYSTATE
Exelixis Clinical Site #292658Newport BeachCalifornia
Exelixis Clinical Site #9895817SacramentoCalifornia
Exelixis Clinical Site #6994115San FranciscoCalifornia
Exelixis Clinical Site #1094305StanfordCalifornia
Exelixis Clinical Site #390502TorranceCalifornia
Exelixis Clinical Site #980045AuroraColorado
Exelixis Clinical Site #2106510New HavenConnecticut
Exelixis Clinical Site #420010Washington D.C.District of Columbia
Exelixis Clinical Site #9433136MiamiFlorida
Exelixis Clinical Site #9332804OrlandoFlorida

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