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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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.
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then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.
Peter Langmuir, MD
United States: Food and Drug Administration
|Research Site||Bentonville, Arkansas|
|Research Site||Anaheim, California|
|Research Site||Boulder, Colorado|
|Research Site||Danbury, Connecticut|
|Research Site||Washington, District of Columbia|
|Research Site||Boca Raton, Florida|
|Research Site||Arlington Heights, Illinois|
|Research Site||Ashland, Kentucky|
|Research Site||Beverly, Massachusetts|
|Research Site||Battle Kreek, Michigan|
|Research Site||Alexandria, Minnesota|
|Research Site||Branson, Missouri|
|Research Site||Albany, New York|
|Research Site||Akron, Ohio|
|Research Site||Bend, Oregon|
|Research Site||Charleston, South Carolina|
|Research Site||Abilene, Texas|
|Research Site||Bennington, Vermont|