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

Thyroid Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01496313
• Other study ID #: D4200C00097
• Secondary ID: 2011-004701-24LP
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 28, 2012
• Est. completion date: June 28, 2024

Study information

• Verified date: September 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 81
• Est. completion date: June 28, 2024
• Est. primary completion date: April 2, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• 300mg vandetanib
Oral blinded tablets taken once daily. At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment Dosing with unblinded study treatment can continue until 24 months after patient was randomised. At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (200mg/day). Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur.
• 150mg vandetanib
Oral blinded tablets taken once daily. At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment. Patients who have not dose reduced at the time of unblinding may have their dose increased to 300mg Dosing with unblinded study treatment can continue until 24 months after patient was randomised At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (100mg/day) [OR 300 reduced to 200mg/day if dose was increased at unblinding.] Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur.

Locations

Country	Name	City	State
Czechia	Research Site	Olomouc
Czechia	Research Site	Praha 5
India	Research Site	Bangalore Karnataka
India	Research Site	Vellore
Israel	Research Site	Beer Sheva
Israel	Research Site	Haifa
Israel	Research Site	Jerusalem
Israel	Research Site	Petach Tikva
Italy	Research Site	Catania
Italy	Research Site	Milano
Italy	Research Site	Palermo
Italy	Research Site	Pisa
Italy	Research Site	Roma
Italy	Research Site	Siena
Italy	Research Site	Torino
Netherlands	Research Site	Groningen
Netherlands	Research Site	Leiden
Poland	Research Site	Gliwice
Poland	Research Site	Warszawa
Poland	Research Site	Zgierz
Russian Federation	Research Site	Saint Petersburg
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Greater London
United Kingdom	Research Site	London
United Kingdom	Research Site	Tyne & Wear
United States	Research Site	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Czechia,  India,  Israel,  Italy,  Netherlands,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator	ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1	Randomisation to week 60 (maximum)
Secondary	Best Objective Response		Randomisation to week 60 (maximum)
Secondary	Duration of Objective Response (RECIST 1.1) by Treatment Arm		Randomization to Week 60 (maximum)
Secondary	Time to Objective Response (RECIST 1.1) by Treatment Arm		Randomization to Week 60 (maximum)
Secondary	Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm		Randomization to Week 60 (maximum)
Secondary	Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.		Week 3 to week 60 (maximum)

External Links

•   D4200C00097_CSR_Synopsis.pdf