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An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
This study is ongoing, but not recruiting participants.
First Received: December 6, 2006   Last Updated: April 30, 2009   History of Changes
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00410761
  Purpose

The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.


Condition Intervention Phase
Thyroid Cancer
 Drug: ZD6474 (Vandetanib)
 Phase II

MedlinePlus related topics: Cancer Thyroid Cancer
Drug Information available for: Vandetanib Thyroid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: An International, Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMA™ ) Versus Placebo in Subjects With Unresectable, Locally Advanced or Metastatic Medullary Thyroid Cancer.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To demonstrate an improvement in progression-free survival with ZD6474 as compared to placebo in subjects with unresectable locally advanced or metastatic medullary thyroid cancer. [ Time Frame: time to progression and death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To demonstrate an improvement in the overall objective response rate, disease control rate, duration of response, overall survival with ZD6474 as compared to placebo. [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Enrollment: 328
Study Start Date: November 2006
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
Placebo vandetanib
2: Experimental
Vandetanib
Drug: ZD6474 (Vandetanib)
once daily oral tablet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410761

  Show 73 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Peter Langmuir, MD AstraZeneca
Principal Investigator: Samuel Wells, MD Duke University
  More Information

Additional Information:
AstraZeneca Clinical Trial Information - Outside US  This link exits the ClinicalTrials.gov site
US and Canada Only  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: D4200C00058
Study First Received: December 6, 2006
Last Updated: April 30, 2009
ClinicalTrials.gov Identifier: NCT00410761     History of Changes
Health Authority: United States: Food and Drug Administration;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Canada: Health Canada;   Spain: Spanish Agency of Medicines;   Switzerland: Swissmedic;   Italy: The Italian Medicines Agency;   Romania: National Medicines Agency;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Germany: Federal Institute for Drugs and Medical Devices;   Mexico: Ministry of Health;   Portugal: National Pharmacy and Medicines Institute;   Sweden: Medical Products Agency;   Hungary: National Institute of Pharmacy;   France: Afssaps - French Health Products Safety Agency;   Austria: Agency for Health and Food Safety;   Denmark: Danish Medicines Agency;   Poland: Ministry of Health;   Belgium: Directorate general for the protection of Public health: Medicines;   Korea: Food and Drug Administration;   China: State Food and Drug Administration;   India: Ministry of Health;   Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Brazil: Ministry of Health

Keywords provided by AstraZeneca:
ZD6474
MTC
Hereditary Medullary Thyroid Cancer
Sporadic Medullary Thyroid Cancer
Medullary Thyroid Cancer

Study placed in the following topic categories:
Thyroid Neoplasms
Head and Neck Neoplasms
Thyroid Cancer, Medullary
Endocrine System Diseases
 Endocrinopathy
Thyroid Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Thyroid Neoplasms
Head and Neck Neoplasms
 Endocrine System Diseases
Thyroid Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009



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