Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer
Status:
Active, not recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
Primary Objective:
To determine the efficacy (as assessed by progression-free survival [PFS]) of vandetanib when
compared to placebo in participants with differentiated thyroid cancer that is either locally
advanced or metastatic who are refractory or unsuitable for radioiodine therapy.
Secondary Objectives:
- To determine the efficacy of vandetanib when compared to placebo in this participant
population as assessed by efficacy variables including duration of response (DOR),
objective response rate (ORR), change in tumour size (TS) and overall survival (OS).
- To evaluate the pharmacokinetics (PK) of vandetanib in this participant population and
potentially investigate any influence of participant demography and pathophysiology on
vandetanib PK.
- To demonstrate an improvement in time to worsening of pain (TWP) in participants treated
with vandetanib when compared to placebo in this participant population.
- To evaluate the safety and tolerability of vandetanib treatment in this participant
population.