A Randomized, Double-blind Study To Evaluate the Efficacyand Safety of Cabozantinib (XL184) at 60 mg/Day Comparedto 140 mg/Day in Progressive, Metastatic Medullary ThyroidCancer Patients - EXAMINER

Exelixis, Inc.0 sites188 target enrollmentDecember 1, 2014

ConditionsProgressive Metastatic Medullary Thyroid Cancer MedDRA version: 20.0Level: PTClassification code 10027105Term: Medullary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsCABOMETYX COMETRIQ

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Progressive Metastatic Medullary Thyroid Cancer
Sponsor: Exelixis, Inc.
Enrollment: 188
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 1, 2014

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Exelixis, Inc.

Eligibility Criteria

Inclusion Criteria

•1\. The subject has a histologically confirmed diagnosis of MTC.
•2\. Availability of tumor tissue for shipment to the central laboratory according to prior
•determination of RET mutation status:
•a. For subjects lacking evidence of a RET or RAS mutation, a recent tumor tissue sample (defined as collected within the 6 months prior to randomization) will be required. Tissue shall come from a progressive tumor location, preferably from the most recently progressed metastatic site if feasible. If a recent tumor sample is
•not available, a tumor biopsy will be obtained during screening.
•b. Subjects with documentation of a RET or RAS mutation found in tumor tissue will not be required to submit a recent tumor tissue sample; however, the report demonstrating the subject’s RET or RAS mutation must be reviewed and approved by the sponsor prior to subject randomization.
•c. For subjects with documentation of a hereditary RET mutation (ie, pathology report showing presence of a specific RET mutation identified in a blood sample), a tumor sample will not be required. Review and approval of the RET mutation report by the sponsor is required prior to randomization of the subject.
•3\. The subject has MTC that is metastatic as determined by the investigator based upon computerized tomography (CT), magnetic resonance imaging (MRI), bone scan, PET scan, or X\-ray taken within 28 days before randomization.
•4\. The subject has disease that is measurable per RECIST 1\.1 as determined by the investigator based upon CT or MRI images taken within 28 days before randomization.
•5\. The subject has documented progressive disease (PD) on CT, MRI, PET scan, bone scan, or X\-ray as determined by the investigator per RECIST 1\.1 on qualifying images taken within 4 months prior to randomization as compared to previous images taken within 14 months before the qualifying images (see Protocol Section 5\.5\.6\.2\).

Exclusion Criteria

•1\. The subject has previously received cabozantinib
•2\. The subject has received prior treatment with a small molecule kinase inhibitor or a hormonal therapy (incl. investigational kinase inhibitors or hormones) within 28 days or five half\-lives of the compound or active metabolites, whichever is shorter before randomization or at any time after the date of the qualifying images used to document PD for eligibility
•3\. The subject has received prior systemic anti\-tumor therapy (eg, chemotherapy, biologic modifiers, or anti\-angiogenic therapy) within 28 days of randomization (42 days for nitrosoureas or/ mitomycin C) or at any time after the date of the qualifying images used to document PD for eligibility
•4\. The subject has received any other type of investigational agent within 28 days before randomization or at any time after the date of the qualifying images used to document PD for eligibility
•5\. The subject has received radiation therapy within 28 days (14 days for radiation for bone metastases) or radionuclide treatment within 42 days of randomization. Subject is ineligible if there are any clinically relevant ongoing complications from prior radiation therapy
•6\. The subject has untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) central nervous system (CNS) metastasis. Must have completed radiation therapy \= 28 days prior to randomization and stable without corticosteroids or anti\-convulsant treatment for \= 10 days
•7\. Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors
•8\. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
•a. Cardiovascular disorders incl.
•i. Symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias