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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
Not Enrolling
Both
Thyroid Neoplasms

Thank you

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