Clinical trial NCT00094055: Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-10-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: 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
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline to disease progression or death due to any cause, assessed every 8 weeks up to 206 weeks
measure: Duration of Response (DR)
timeFrame: Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 206 weeks
measure: Overall Survival (OS)
timeFrame: Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant
Other outcomes:
measure: Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations
timeFrame: Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 206 weeks
measure: Plasma Concentrations of Soluble Proteins
timeFrame: Day 1 (pre-dose) and then every 8 weeks up to 206 weeks
Locations:
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Cohen EE, Tortorici M, Kim S, Ingrosso A, Pithavala YK, Bycott P. A Phase II trial of axitinib in patients with various histologic subtypes of advanced thyroid cancer: long-term outcomes and pharmacokinetic/pharmacodynamic analyses. Cancer Chemother Pharmacol. 2014 Dec;74(6):1261-70. doi: 10.1007/s00280-014-2604-8. Epub 2014 Oct 15.