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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.


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Thyroid Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



- Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or
sporadic Medullary Thyroid Cancer.

- Presence of measurable tumor

- Able to swallow medication

Exclusion Criteria:

- Major surgery within 4 weeks before randomization

- Last dose of prior chemotherapy received less than 4 weeks prior to randomization

- Radiation therapy within the last 4 weeks prior to randomization(with exception of
palliative radiotherapy)

- Brain metastases or spinal cord compression, unless treated at least 4 weeks before
first dose and stable without steroid treatment for 10 days

- Significant cardiac events

- Previous ZD6474 treatment

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then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.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

Name

Location
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