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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Thyroid Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Objective Response (OR)

Outcome Description:

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Outcome Time Frame:

Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 206 weeks

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:

A4061014

NCT ID:

NCT00094055

Start Date:

September 2004

Completion Date:

January 2009

Related Keywords:

  • Thyroid Neoplasms
  • Neoplasms
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535