Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Thyroid Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Axitinib [AG-013736]

Group Type EXPERIMENTAL

AG013736

Intervention Type DRUG

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

Interventions

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AG013736

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No