To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer

Phase 4

Completed

Brief Summary: The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.

Detailed Description: An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease

Recruitment & Eligibility

Inclusion Criteria

Written consent from Female or male patients aged 18 years and over. Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC Objective disease progression within the previous 14 months prior to enrolment, and/or
Have one or more symptoms that the Investigator believes to be related to the patient's MTC.
World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
Has measurable disease (at least one lesion, not irradiated within 12 weeks of study randomisation, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI).
Lesions must be amenable to accurate and repeat measurement.

Exclusion Criteria

Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before randomization.
Abnormal liver function tests (bilirubin more than 1.5xULRR, and ALT, AST, or ALP more than 2.5xULRR or 5.0xULRR if related to liver metastases).
Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or more than 450 ms.
Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
For women only - currently pregnant or breast feeding.

Arm && Interventions

Group	Intervention	Description
300mg vandetanib	300mg vandetanib	-
150mg vandetanib	150mg vandetanib	-

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator	Randomisation to week 60 (maximum)	ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1

Secondary Outcome Measures

Name	Time	Method
Time to Objective Response (RECIST 1.1) by Treatment Arm	Randomization to Week 60 (maximum)
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm	Randomization to Week 60 (maximum)
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.	Week 3 to week 60 (maximum)
Duration of Objective Response (RECIST 1.1) by Treatment Arm	Randomization to Week 60 (maximum)
Best Objective Response	Randomisation to week 60 (maximum)

Locations (5): Investigational Site Number : 1903
🇨🇿
Olomouc, Czechia
Investigational Site Number : 1901
🇨🇿
Praha, Czechia
Investigational Site Number : 5704
🇵🇱
Warsaw, Mazowieckie, Poland
Investigational Site Number : 5703
🇵🇱
Gliwice, Poland
Research Site
🇬🇧
Tyne & Wear, United Kingdom