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

NCT ID: NCT00389441

Last Updated: 2013-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2012-09-30

Brief Summary

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

Detailed Description

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Additional study details: assess safety and efficacy

Conditions

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Thyroid Neoplasms

Keywords

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VEGFR inhibitor tyrosine kinase inhibitor anti-angiogenic carcinoma papillary follicular medullary anaplastic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

AG-013736

Intervention Type DRUG

AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity

Interventions

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AG-013736

AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Orange, California, United States

Site Status

Pfizer Investigational Site

Aurora, Colorado, United States

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Pfizer Investigational Site

Tampa, Florida, United States

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Chicago, Illinois, United States

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Wichita, Kansas, United States

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Witchita, Kansas, United States

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Boston, Massachusetts, United States

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Pfizer Investigational Site

Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Buffalo, New York, United States

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Edmonton, Alberta, Canada

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London, Ontario, Canada

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Montreal, Quebec, Canada

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Nanjing, Jiangsu, China

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Beijing, , China

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Shanghai, , China

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Shanghai, , China

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Prague, , Czechia

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Vellore, Tamil Nadu, India

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Milan, , Italy

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Pisa, , Italy

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Gliwice, , Poland

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Warsaw, , Poland

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Madrid, Madrid, Spain

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Pfizer Investigational Site

Pamplona, Navarre, Spain

Site Status

Pfizer Investigational Site

Glasgow, , United Kingdom

Site Status

Countries

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Israel United States Canada China Czechia India Italy Poland Spain United Kingdom

References

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Locati LD, Licitra L, Agate L, Ou SH, Boucher A, Jarzab B, Qin S, Kane MA, Wirth LJ, Chen C, Kim S, Ingrosso A, Pithavala YK, Bycott P, Cohen EE. Treatment of advanced thyroid cancer with axitinib: Phase 2 study with pharmacokinetic/pharmacodynamic and quality-of-life assessments. Cancer. 2014 Sep 1;120(17):2694-703. doi: 10.1002/cncr.28766. Epub 2014 May 20.

Reference Type DERIVED
PMID: 24844950 (View on PubMed)

Related Links

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Other Identifiers

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A4061027

Identifier Type: -

Identifier Source: org_study_id