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Vandetanib 150mg vs 300mg in medullary thyroid carcinoma

NCT01496313Phase 4

Key facts

Status: Completed
Start: Jun 2012
Primary completion: Apr 2014
Countries: 9
Sponsor: Sanofi
Modality: Small Molecules

Drugs: vandetanib
Conditions: medullary thyroid carcinoma (MTC)

Overview

Phase 4, randomised, double-blind trial of vandetanib in medullary thyroid carcinoma (MTC) (2 arms), sponsored by Sanofi. Primary endpoint: Overall Response Rate at 60 weeks. Started Jun 2012; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

300mg vandetanib
Vandetanib 300mg oral tablets once daily
150mg vandetanib
Vandetanib 150mg oral tablets once daily

Who it enrols

Adults 18+ with histologically confirmed unresectable locally advanced or metastatic medullary thyroid carcinoma with objective disease progression within 14 months or symptomatic disease, ECOG 0-2, measurable disease, adequate organ function, and no significant cardiac abnormalities

Endpoints

Primary

Overall Response Rate60 weeks

Secondary

Best Objective Response60 weeks
Duration of Objective Response60 weeks
Time to Objective Response60 weeks
Percentage Change From Baseline in Target Lesion Size60 weeks
Plasma Concentration of Vandetanib60 weeks

Results

Not all primary endpoints met

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