Clinical trial NCT01496313: To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thyroid Cancer
Keywords: medullary thyroid cancer
metastatic
thyroid cancer
carcinoma of the thyroid
receptor tyrosine kinase inhibitor
VEGFR
Unresectable locally advanced thyroid cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-12-21
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator
timeFrame: Randomisation to week 60 (maximum)
Secondary outcomes:
measure: Best Objective Response
timeFrame: Randomisation to week 60 (maximum)
measure: Duration of Objective Response (RECIST 1.1) by Treatment Arm
timeFrame: Randomization to Week 60 (maximum)
measure: Time to Objective Response (RECIST 1.1) by Treatment Arm
timeFrame: Randomization to Week 60 (maximum)
measure: Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
timeFrame: Randomization to Week 60 (maximum)
measure: Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.
timeFrame: Week 3 to week 60 (maximum)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Research Site
state: Texas
city: Olomouc
country: Czechia
facility: Investigational Site Number : 1903
city: Olomouc
country: Czechia
facility: Research Site
city: Praha 5
country: Czechia
facility: Research Site
city: Praha
country: Czechia
facility: Investigational Site Number : 1901
city: Bangalore Karnataka
country: India
facility: Research Site
city: Vellore
country: India
facility: Research Site
city: Beer Sheva
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Petach Tikva
country: Israel
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Siena
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Warsaw
country: Poland
facility: Investigational Site Number : 5704
state: Mazowieckie
city: Gliwice
country: Poland
facility: Investigational Site Number : 5703
city: Gliwice
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Zgierz
country: Poland
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Greater London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Tyne & Wear
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_CHAIR
References: