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

Completed · Phase 4

Conditions studied: Thyroid Cancer

In brief

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.

Key facts

Study ID

NCT01496313

Run by

Sanofi

People needed

81

Starts

2012-06-08

Expected to finish

2024-07-11

Last updated by the study team

2025-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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