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

Sponsor
Exelixis
Study ID
NCT01896479
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Medullary Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 25, 2015
Status verified
Aug 2025
Primary completion
Jul 15, 2020
Completion
Jan 31, 2035

Study Design

Enrollment
247 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib (XL184) 60 mg
    Cabozantinib (XL184) 140 mg as capsules and placebo tablets administered orally once a day.
  • Experimental: Cabozantinib (XL184) 140 mg
    Cabozantinib (XL184) 140 mg as tablets and placebo capsules administered orally once a day.

Primary Outcome Measure

Progression Free Survival (PFS) Per Blinded Independent Radiology Committee (BIRC) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Median time of follow-up (from the date of randomization of the first participant through primary data cut off [15 July 2020]) was 30.2 months ]

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