Status:
COMPLETED
To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
Lead Sponsor:
Sanofi
Conditions:
Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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 Thy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 8 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2024
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01496313
Start Date
June 8 2012
End Date
July 11 2024
Last Update
October 3 2025
Active Locations (30)
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1
Research Site
Houston, Texas, United States
2
Investigational Site Number : 1903
Olomouc, Czechia, 77900
3
Research Site
Olomouc, Czechia
4
Investigational Site Number : 1901
Prague, Czechia, 15006