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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00389441

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 Carcinoma, Papillary, Follicular, Medullary, Anaplastic	Drug: AG-013736	Phase II

MedlinePlus related topics: Cancer Thyroid Cancer

Drug Information available for: Thyroid Axitinib Tyrosine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Objective response rate (ORR) according to RECIST criteria [ Time Frame: Dec 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety profile of AG 013736 [ Time Frame: Dec 2009 ] [ Designated as safety issue: No ]
Progression-free survival (PFS) [ Time Frame: Dec 2009 ] [ Designated as safety issue: No ]
Duration of response (DR) [ Time Frame: Dec 2009 ] [ Designated as safety issue: No ]
Patient reported outcomes (PRO) [ Time Frame: Dec 2009 ] [ Designated as safety issue: No ]
Overall survival (OS) [ Time Frame: Dec 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	52
Study Start Date:	December 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: AG-013736 AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity

Detailed Description:

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

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 26 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4061027
Study First Received:	October 16, 2006
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00389441
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

VEGFR inhibitor, tyrosine kinase inhibitor, anti-angiogenic

Study placed in the following topic categories:

Adenocarcinoma, Follicular
Thyroid Neoplasms
Endocrine System Diseases
Carcinoma
Head and Neck Neoplasms
Carcinoma, Papillary, Follicular
Carcinoma, Papillary

Neoplasms, Squamous Cell
Endocrinopathy
Adenocarcinoma
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Adenocarcinoma, Papillary
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009