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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
247
Progression Free Survival (PFS) Per Blinded Independent Radiology Committee (BIRC) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS per BIRC per RECIST 1.1 was measured from randomization until the date of first documented disease progression or date of death from any cause, whichever came first, and was assessed for up to 31 months. The prespecified primary analysis was triggered by the required number of at least 150 events occurring in the ITT population, The data cutoff date for this event-driven analysis in the ITT population was when a total of 155 events were reported. Median PFS was calculated using the Kaplan-Meier estimates.
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
Objective Response Rate (ORR) Per BIRC Per RECIST 1.1
ORR per BIRC per RECIST 1.1 is the percentage of ITT participants who experienced a best overall response of complete response (CR) or partial response (PR), confirmed ≥ 28 days later, CR defined as disappearance of all non-target lesions. All lymph nodes must have been non-pathological in size (\<10 mm short axis). PR defined as unequivocal progression of non-target lesions. Unequivocal progression was to trump target lesion status. It must have been representative of overall disease status change, not a single lesion increase.
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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St Leonards, New South Wales, Australia
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Herston, Queensland, Australia
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Kurralta Park, South Australia, Australia
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Parkville, Victoria, Australia
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Québec, Quebec, Canada
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Toronto, Canada
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Osijek, Croatia
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Zagreb, Croatia
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Zagreb, Croatia
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Bordeaux, Gironde, France
...and 39 more locations