To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
NCT ID: NCT01496313
Last Updated: 2025-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
81 participants
INTERVENTIONAL
2012-06-08
2024-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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300mg vandetanib
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_CHAIR
Sanofi
Locations
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Research Site
Houston, Texas, United States
Investigational Site Number : 1903
Olomouc, , Czechia
Research Site
Olomouc, , Czechia
Investigational Site Number : 1901
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Bangalore Karnataka, , India
Research Site
Vellore, , India
Research Site
Beersheba, , Israel
Research Site
Haifa, , Israel
Research Site
Jerusalem, , Israel
Research Site
Petah Tikva, , Israel
Research Site
Catania, , Italy
Research Site
Milan, , Italy
Research Site
Palermo, , Italy
Research Site
Pisa, , Italy
Research Site
Roma, , Italy
Research Site
Siena, , Italy
Research Site
Torino, , Italy
Research Site
Groningen, , Netherlands
Research Site
Leiden, , Netherlands
Investigational Site Number : 5704
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 5703
Gliwice, , Poland
Research Site
Gliwice, , Poland
Research Site
Warsaw, , Poland
Research Site
Zgierz, , Poland
Research Site
Saint Petersburg, , Russia
Research Site
Cardiff, , United Kingdom
Research Site
Greater London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Tyne & Wear, , United Kingdom
Countries
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Related Links
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Other Identifiers
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LPS14809
Identifier Type: OTHER
Identifier Source: secondary_id
2011-004701-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4200C00097
Identifier Type: -
Identifier Source: org_study_id
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