An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMATM) Versus Placebo in Subjects With Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival(PFS)

Outcome Description:

Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.

Outcome Time Frame:

RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.

Safety Issue:

No

Principal Investigator

Peter Langmuir, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D4200C00058

NCT ID:

NCT00410761

Start Date:

November 2006

Completion Date:

December 2016

Related Keywords:

• Thyroid Cancer
• ZD6474
• MTC
• Hereditary Medullary Thyroid Cancer
• Sporadic Medullary Thyroid Cancer
• Medullary Thyroid Cancer
• Thyroid Neoplasms
• Thyroid Diseases