Locally advanced or metastatic medullary thyroid cancer MedDRA version: 19.0 Level: PT Classification code 10027105 Term: Medullary thyroid cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Genzyme Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Provision of informed consent prior to any study specific procedures Female or male aged 18 years and over Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC. Documentation must be provided in patient's medical chart WHO or ECOG Performance status 0-2 Negative pregnancy test (urine or serum) for female patients of childbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Unstable brain metastases or spinal cord compression that require treatment, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days Major surgery within 4 weeks before randomization The last dose of prior chemotherapy received less than 3 weeks prior to randomization Radiation therapy not completed prior to the first dose of vandetanib Significant cardiac event, superior vena cava syndrome, NYHA classification of heart disease =2, within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases risk of ventricular arrhytmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate a decrease in the percentage of time patients with locally advanced or metastatic medullary thyroid cancer experience AEs of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of a patient outreach programme;Secondary Objective: To collect additional information on the safety and tolerability of vandetanib in patients with locally advanced or metastatic medullary thryroid cancer;Primary end point(s): Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program ;Timepoint(s) of evaluation of this end point: During the first 12 months on treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities;Timepoint(s) of evaluation of this end point: During the first 12 months on treatment | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, Germany, Greece, India, Israel, Italy, Korea, Republic of, Norway, Poland, Russian Federation, Sweden, Switzerland, United Kingdom
Contacts
Public ContactBrigitte De-witte
Sanofi-aventis Belgium
Outcome results
None listed