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

NCT00389441

Last updated date
Study Location
Pfizer Investigational Site
Orange, California, 92868, United States
Contact
1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Thyroid Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Radioiodine-refractory metastatic or unresectable locally-advanced thyroid cancer

- At least 1 measurable target lesion, as defined by RECIST

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Thyroid NeoplasmsStudy Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer NCT00389441
  1. Orange, California
  2. Aurora, Colorado
  3. Tampa, Florida
  4. Chicago, Illinois
  5. Wichita, Kansas
  6. Witchita, Kansas
  7. Boston, Massachusetts
  8. Boston, Massachusetts
  9. Boston, Massachusetts
  10. Buffalo, New York
  11. Edmonton, Alberta
  12. London, Ontario
  13. Montreal, Quebec
  14. Nanjing, Jiangsu
  15. Beijing,
  16. Shanghai,
  17. Shanghai,
  18. Praha 5,
  19. Vellore, Tamil Nadu
  20. Milano,
  21. Pisa,
  22. Gliwice,
  23. Warszawa,
  24. Pamplona, Navarra
  25. Madrid,
  26. Glasgow,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Thyroid NeoplasmsStudy of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer NCT00094055
  1. Santa Monica, California
  2. Aurora, Colorado
  3. Denver, Colorado
  4. Chicago, Illinois
  5. Baltimore, Maryland
  6. Baltimore, Maryland
  7. Ann Arbor, Michigan
  8. Philadelphia, Pennsylvania
  9. Houston, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer
Official Title  ICMJE A Pivotal Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With 131I-Refractory Metastatic Or Unresectable Locally-Advanced Thyroid Cancer
Brief Summary The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer that is resistant to radioactive iodine
Detailed Description Additional study details: assess safety and efficacy
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Thyroid Neoplasms
Intervention  ICMJE Drug: AG-013736
AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity
Study Arms  ICMJE Experimental: A
Intervention: Drug: AG-013736
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2008)
52
Original Enrollment  ICMJE
 (submitted: October 17, 2006)
100
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   China,   Czech Republic,   India,   Italy,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries Israel
 
Administrative Information
NCT Number  ICMJE NCT00389441
Other Study ID Numbers  ICMJE A4061027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP