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Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00389441
First received: October 16, 2006
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  Purpose

The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer that is resistant to radioactive iodine


Condition Intervention Phase
Thyroid Neoplasms
 Drug: AG-013736
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Pivotal Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With 131I-Refractory Metastatic Or Unresectable Locally-Advanced Thyroid Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Objective response rate (ORR) according to RECIST criteria [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Duration of response (DR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Patient reported outcome: MD Anderson Symptom Inventory (MDASI) questionnaire [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety profile of AG0013736: Safety profile characterized by type, grade and frequency of all adverse events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety profile of AG0013736: Safety profile characterized by laboratory abnormalities [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: December 2006
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: AG-013736
AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity

Detailed Description:

Additional study details: assess safety and efficacy

  Eligibility

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

Inclusion Criteria:

  • Radioiodine-refractory metastatic or unresectable locally-advanced thyroid cancer
  • At least 1 measurable target lesion, as defined by RECIST 

Exclusion Criteria:

  • Thyroid lymphoma
  • Previous treatment with anti-angiogenesis agents
  • No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism within 12 months prior.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389441

  Show 26 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00389441     History of Changes
Other Study ID Numbers: A4061027
Study First Received: October 16, 2006
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
VEGFR inhibitor
tyrosine kinase inhibitor
anti-angiogenic
carcinoma
 papillary
follicular
medullary
anaplastic

Additional relevant MeSH terms:
Neoplasms
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013