Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Locally Advanced or Metastatic Medullary Thyroid Cancer, Medullary Thyroid Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

AEs will be collected over 52 weeks on treatment

Safety Issue:

Yes

Principal Investigator

Lars Bastholt, MD DPM

Investigator Role:

Principal Investigator

Investigator Affiliation:

Odense University Hospital

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

D4200C00088

NCT ID:

NCT01298323

Start Date:

February 2011

Completion Date:

May 2013

Related Keywords:

  • Locally Advanced or Metastatic Medullary Thyroid Cancer
  • Medullary Thyroid Cancer
  • Medullary Thyroid Cancer
  • Locally advanced
  • Metastatic
  • Vandetanib
  • Patient Outreach
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location