Phase 2
N=60
Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer
Thyroid Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00094055 ↗Enrolled (actual)
60
Serious AEs
53.3%
Results posted
Mar 2012
Primary outcome: Primary: Percentage of Participants With Objective Response (OR) — 38.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AG013736 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR) |
38.3 | — |
| SECONDARY Progression-Free Survival (PFS) |
459 | — |
| SECONDARY Duration of Response (DR) |
625 | — |
| SECONDARY Overall Survival (OS) |
1068 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00094055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.