This trial is active, not recruiting.

Conditions locally advanced or metastatic medullary thyroid cancer, medullary thyroid cancer
Treatments patient outreach, vandetanib
Phase phase 3
Target VEGF
Sponsor AstraZeneca
Start date February 2011
End date April 2013
Trial size 217 participants
Trial identifier NCT01298323, 2010-023428-26, D4200C00088


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Control - treatment 300mg vandetanib opel label
Treatment 300mg vandetanib opel label.
Experimental - treatment 300mg vandetanib opel label
patient outreach
Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner
Treatment 300mg vandetanib opel label.

Primary Outcomes

Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program.
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized,Int.,Open-Label Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients With Locally Advanced or Metastatic MTC Experience Grade 2 or Higher AEs in the First 12 Months of Treatment With Vandetanib
Principal investigator Lars Bastholt, MD DPM
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by AstraZeneca.