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Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer

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NCT00094055

Last updated on December 4, 2019
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Study Location
Pfizer Investigational Site
Santa Monica, California, 90404 United States
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Contact
1-800-718-1021
[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

- Histologically documented thyroid cancer with metastases.

- Failure of radioactive iodine (131I) to control the disease or radioactive iodine
(131I) is not an appropriate therapy (e.g. due to lack of iodine uptake by the tumor)

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

- Central lung lesions involving major blood vessels (arteries or veins).(Central
lesions that maintain the structural integrity of vessels have the potential to bleed
if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any
case where there is any question as to whether blood vessels are involved.)

- Patients with a history of hemoptysis

NCT00094055
Pfizer
Completed
Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer

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Descriptive Information
Brief Title  ICMJE Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer
Official Title  ICMJE Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer Who Are Refractory to or Not Suitable Candidates for 131 I Treatment
Brief SummaryThis is a Phase 2 study being conducted at multiple centers in the United States. Patients having thyroid cancer that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that was not controlled by previous treatment with radioactive iodine (131I) or not be good candidates for such treatment. The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic thyroid cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thyroid Neoplasms
Intervention  ICMJE Drug: AG013736
AG013736, tablets 5 mg BID daily until tumor progression or toxicity
Study Arms  ICMJE Experimental: Axitinib [AG-013736]
Intervention: Drug: AG013736
Publications *Cohen EE, Tortorici M, Kim S, Ingrosso A, Pithavala YK, Bycott P. A Phase II trial of axitinib in patients with various histologic subtypes of advanced thyroid cancer: long-term outcomes and pharmacokinetic/pharmacodynamic analyses. Cancer Chemother Pharmacol. 2014 Dec;74(6):1261-70. doi: 10.1007/s00280-014-2604-8. Epub 2014 Oct 15.


*   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: January 30, 2009)		60
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion DateJanuary 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically documented thyroid cancer with metastases.
  • Failure of radioactive iodine (131I) to control the disease or radioactive iodine (131I) is not an appropriate therapy (e.g. due to lack of iodine uptake by the tumor)

Exclusion Criteria:

  • Central lung lesions involving major blood vessels (arteries or veins).(Central lesions that maintain the structural integrity of vessels have the potential to bleed if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any case where there is any question as to whether blood vessels are involved.)
  • Patients with a history of hemoptysis
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00094055
Other Study ID Numbers  ICMJE A4061014
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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