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Expanded Access of Cabozantinib in Medullary Thyroid Cancer | Clinical Trials | Clareo Health

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Expanded Access of Cabozantinib in Medullary Thyroid Cancer

An Open-Label, Expanded Access Study of Cabozantinib (XL184) in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer

NCT01683110•Exelixis

View on ClinicalTrials.gov

Summary

The objective of this study is to provide access to cabozantinib for eligible subjects with medullary thyroid cancer (MTC) pending approval of Exelixis' New Drug Application (NDA) by the FDA and commercial availability of cabozantinib.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subject has histologically confirmed diagnosis of MTC that is unresectable, locally advanced, or metastatic
•The subject has documented progressive disease (PD) as determined by the investigator
•The subject has been previously treated with available standard therapy for unresectable, locally advanced, or metastatic MTC; or other currently available therapy is considered inappropriate for the subject as determined by the investigator
•The subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
•The subject has adequate organ and marrow function
•The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document
•Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 3 months after the last dose of cabozantinib received as part of this study, even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control.

Exclusion Criteria

•The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, antibodies) within 4 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of cabozantinib
•The subject has previously been enrolled in a clinical trial evaluating cabozantinib including placebo-controlled trials in which the subject may not have been treated with cabozantinib
•The subject has received radiation therapy:
•1. to the thoracic cavity, abdomen, or pelvis within 12 weeks before the first dose of study treatment , or has ongoing complications or is without complete recovery and healing from prior radiation therapy
•2. to bone or brain metastasis within 14 days before the first dose of cabozantinib
•3. to any other site(s) within 28 days before the first dose of cabozantinib
•The subject has received radionuclide treatment within 6 weeks before the first dose of cabozantinib
•The subject has received prior treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within 14 days or five half-lifes of the compound or active metabolites, whichever is longer, before the first dose of cabozantinib
•The subject has received any other type of investigational agent within 28 days before the first dose of cabozantinib
•The subject has not recovered to baseline or CTCAE ≤ Grade 1 from toxicity due to all prior therapies except alopecia and other clinically non-significant side effects
+15 more criteria

Locations (5)

Stanford, California, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Key Dates

Last Updated

January 16, 2013

Conditions

Medullary Thyroid Cancer

Interventions

cabozantinib

DRUG

Natural History Study of Children and Adults With Medullary Thyroid Cancer

NCT01660984

Medullary Thyroid Cancer

View study

RECRUITINGPHASE1/PHASE2

Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors

NCT06814496

MelanomaMedullary Thyroid Cancer+9 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Expanded Access of Cabozantinib in Medullary Thyroid Cancer

Inclusion Criteria

Exclusion Criteria

Natural History Study of Children and Adults With Medullary Thyroid Cancer

Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors

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