Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment

Sanofi

Status and phase: Completed; Phase 3

Conditions: Medullary Thyroid Cancer; Locally Advanced or Metastatic Medullary Thyroid Cancer

Treatments: Drug: Vandetanib; Behavioral: Patient outreach

Study type: Interventional

Funder types: Industry

Identifiers

NCT01298323

D4200C00088

LPS14815 (Other Identifier)

2010-023428-26 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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 arrhythmia
• Creatinine clearance <30 ml/min (calculated by Cockcroft-Gault formula),Patients with moderate renal impairment, defined as creatinine clearance ≥30 to <50 ml/min, must start vandetanib at a reduced dose of 200 mg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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205 participants in 2 patient groups

Vandetanib Control

Active Comparator group

Description:

Control - treatment 300mg vandetanib opel label

Treatment:

Drug: Vandetanib

Experimental

Experimental group

Description:

Experimental - treatment 300mg vandetanib opel label

Treatment:

Behavioral: Patient outreach

Drug: Vandetanib