A Pivotal Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With 131I-Refractory Metastatic Or Unresectable Locally-Advanced Thyroid Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Thyroid Neoplasms
Both
Thyroid Neoplasms
Trial Information
A Pivotal Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With 131I-Refractory Metastatic Or Unresectable Locally-Advanced Thyroid Cancer
Additional study details: assess safety and efficacy
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Objective response rate (ORR) according to RECIST criteria
Outcome Time Frame:
4 years
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A4061027
NCT ID:
NCT00389441
Start Date:
December 2006
Completion Date:
September 2012
Related Keywords:
- Thyroid Neoplasms
- VEGFR inhibitor
- tyrosine kinase inhibitor
- anti-angiogenic
- carcinoma
- papillary
- follicular
- medullary
- anaplastic
- Neoplasms
- Thyroid Neoplasms
- Thyroid Diseases
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Aurora, Colorado 80012 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Kansas City, Kansas 66112 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
