Cabozantinib for Thyroid Cancer

Recruiting in Palo Alto (17 mi)

+165 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Exelixis

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults with differentiated thyroid cancer that's gotten worse after treatment with specific drugs targeting blood vessel growth. They must have tried or be ineligible for Iodine-131 therapy, and can't have had more than two such prior treatments. Good physical health (ECOG 0 or 1) is required, and they shouldn't have received recent anticancer therapies or radiation, nor should they have certain brain metastases.

Inclusion Criteria

You have received treatment with Iodine-131 for differentiated thyroid cancer (DTC) in the past, or you are not eligible for this treatment.

You have already been treated with a specific type of medication for your thyroid cancer, and you may have been treated with up to two different medications of this type.

You should be able to carry out all your normal activities without any restrictions or only have a little restriction in physically strenuous activity.

Exclusion Criteria

Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization

You have had radiation treatment for cancer within the past few weeks.

You have cancer that has spread to your brain, unless it has been treated well.

Treatment Details

Interventions

• Cabozantinib (Tyrosine Kinase Inhibitor)
• Placebo (Chemotherapy)

Trial Overview The study tests Cabozantinib against a placebo in patients whose thyroid cancer has not responded to previous treatments aimed at blocking blood vessel growth. It aims to see if Cabozantinib can slow the disease's progression and improve response rates compared to no active treatment.

Participant Groups

Group I: Cabozantinib Experimental Treatment 1 Intervention

cabozantinib (60 mg) once daily orally (qd)

Group II: Placebo Placebo Group 1 Intervention

placebo once daily orally (qd)

Cabozantinib is already approved in Canada, Japan for the following indications:

Approved in Canada as Cabometyx for:

• Renal cell carcinoma
• Hepatocellular carcinoma

Approved in Japan as Cabometyx for:

• Renal cell carcinoma

Who Is Running the Clinical Trial?

Exelixis

Lead Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Ipsen

Industry Sponsor

Trials

358

Recruited

74,600+

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD