A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

Part of paid clinical trials in Newport Beach, California.

Sponsor
Exelixis
Study ID
NCT03690388
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Differentiated Thyroid Cancer

Eligibility Criteria

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

Interventions

  • Cabozantinib — DRUG
    Tablets containing 60-mg or 20-mg cabozantinib once daily orally.
  • Placebo — DRUG
    Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.

Study Details

The objective of this study is to evaluate the effect of cabozantinib compared with placebo on progression free survival (PFS) and objective response rate (ORR) in subjects with Radioiodine-Refractory Differentiated Thyroid Cancer (DTC) who have progressed after prior vascular endothelial growth factor receptor (VEGFR)-Targeted therapy.

Key Dates

Start date
Oct 5, 2018
Status verified
Sep 2025
Primary completion
Aug 19, 2020
Completion
Jul 31, 2026

Study Design

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

Arms

  • Experimental: Cabozantinib
    cabozantinib (60 mg) once daily orally (qd)
  • Placebo Comparator: Placebo
    placebo once daily orally (qd)

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to approximately twenty months after the first subject is randomized. Time from randomization to the earlier of the following events: radiographic PD as determined by the blinded independent central review (BIRC) or death due to any cause. ]

Locations (31)

FacilityCityStateZIPSite coordinators
Exelixis Clinical Site #2Newport BeachCalifornia92658-
Exelixis Clinical Site #98SacramentoCalifornia95817-
Exelixis Clinical Site #69San FranciscoCalifornia94115-
Exelixis Clinical Site #10StanfordCalifornia94305-
Exelixis Clinical Site #3TorranceCalifornia90502-
Exelixis Clinical Site #9AuroraColorado80045-
Exelixis Clinical Site #21New HavenConnecticut06510-
Exelixis Clinical Site #4Washington D.C.District of Columbia20010-
Exelixis Clinical Site #94MiamiFlorida33136-
Exelixis Clinical Site #93OrlandoFlorida32804-
Exelixis Clinical Site #6TampaFlorida33612-
Exelixis Clinical Site #164ChicagoIllinois60637-
Exelixis Clinical Site #54LexingtonKentucky40536-
Exelixis Clinical Site #153BostonMassachusetts02114-
Exelixis Clinical Site #80Ann ArborMichigan48109-
Exelixis Clinical Site #22DetroitMichigan48202-
Exelixis Clinical Site #78DetroitMichigan48201-
Exelixis Clinical Site #63ColumbiaMissouri65212-
Exelixis Clinical Site #42St LouisMissouri63110-
Exelixis Clinical Site #11OmahaNebraska68114-
Exelixis Clinical Site #118MorristownNew Jersey07962-
Exelixis Clinical Site #76CharlotteNorth Carolina28204-
Exelixis Clinical Site #19DurhamNorth Carolina27710-
Exelixis Clinical Site #7CincinnatiOhio45219-
Exelixis Clinical Site #5BethlehemPennsylvania18015-
Exelixis Clinical Site #1PhiladelphiaPennsylvania19104-
Exelixis Clinical Site #75PittsburghPennsylvania15232-
Exelixis Clinical Site #134CharlestonSouth Carolina29425-
Exelixis Clinical Site #68NashvilleTennessee37232-
Exelixis Clinical Site #8HoustonTexas77030-
Exelixis Clinical Site #113SeattleWashington98109-

Find similar trials in Newport Beach, CA

By research site
Exelixis Clinical· Newport Beach, CAExelixis Clinical· Sacramento, CAExelixis Clinical· San Francisco, CAExelixis Clinical· Stanford, CAExelixis Clinical· Torrance, CAExelixis Clinical· Aurora, CO

Related Studies