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A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer

NCT01896479 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2025-09-02

Study results available
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Summary

The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a 60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will test if the lower dose results in similar progression free survival (PFS) and overall response rate (ORR) with fewer adverse events compared to the PFS, ORR and adverse events found in previous clinical trials of 140 mg.

Conditions

Interventions

DRUG

Cabozantinib (XL184) 140 mg

DRUG

Cabozantinib (XL184) 60 mg

DRUG

Placebo tablet

DRUG

Placebo capsule

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-25
Primary Completion
2020-07-15
Completion
2035-01-31

Countries

  • Australia
  • Canada
  • Croatia
  • France
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01896479 on ClinicalTrials.gov