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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00094055
Other study ID # A4061014
Secondary ID
Status Completed
Phase Phase 2
First received October 8, 2004
Last updated June 21, 2012
Start date September 2004
Est. completion date January 2009

Study information

Verified date June 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
AG013736
AG013736, tablets 5 mg BID daily until tumor progression or toxicity

Locations

Country Name City State
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Objective Response (OR) 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. 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 No
Secondary Progression-Free Survival (PFS) Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). Baseline to disease progression or death due to any cause, assessed every 8 weeks up to 206 weeks No
Secondary Duration of Response (DR) Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response. Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 206 weeks No
Secondary Overall Survival (OS) Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact. Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant No
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