Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer
NCT00389441
Last updated date
ABOUT THIS STUDY
The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer
that is resistant to radioactive iodine
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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
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ALL GENDERS
18 Years+
years
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Thyroid NeoplasmsStudy of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer
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- Santa Monica, California
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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 | 52 | |||
| Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||