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

Exelixis

Status and phase: Active, not recruiting; Phase 3

Conditions: Differentiated Thyroid Cancer

Treatments: Drug: Cabozantinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03690388

2024-516478-31-00 (EU Trial (CTIS) Number)

XL184-311

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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187 participants in 2 patient groups, including a placebo group

Cabozantinib

Experimental group

Description:

cabozantinib (60 mg) once daily orally (qd)

Treatment:

Drug: Cabozantinib

Placebo

Placebo Comparator group

Description:

placebo once daily orally (qd)

Treatment:

Drug: Placebo