Clinical trial NCT00389441: Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer
Official title: A Pivotal Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With 131I-Refractory Metastatic Or Unresectable Locally-Advanced Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Neoplasms
Keywords: VEGFR inhibitor
tyrosine kinase inhibitor
anti-angiogenic
carcinoma
papillary
follicular
medullary
anaplastic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer that is resistant to radioactive iodine

Detailed description: Additional study details: assess safety and efficacy

Eligibility criteria: Inclusion Criteria:

* Radioiodine-refractory metastatic or unresectable locally-advanced thyroid cancer
* At least 1 measurable target lesion, as defined by RECIST

Exclusion Criteria:

* Thyroid lymphoma
* Previous treatment with anti-angiogenesis agents
* No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism within 12 months prior.

Primary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)
measure: Duration of Response (DR)
timeFrame: Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)
measure: Overall Survival (OS)
timeFrame: Baseline to death due to any cause or at least 2 year after the first dose for the last participant
measure: Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score
timeFrame: Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)
measure: Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score
timeFrame: Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)
Other outcomes:
Locations:
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Witchita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Nanjing
country: China
facility: Pfizer Investigational Site
state: Jiangsu
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Praha 5
country: Czech Republic
facility: Pfizer Investigational Site
city: Vellore
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Gliwice
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Pamplona
country: Spain
facility: Pfizer Investigational Site
state: Navarra
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Locati LD, Licitra L, Agate L, Ou SH, Boucher A, Jarzab B, Qin S, Kane MA, Wirth LJ, Chen C, Kim S, Ingrosso A, Pithavala YK, Bycott P, Cohen EE. Treatment of advanced thyroid cancer with axitinib: Phase 2 study with pharmacokinetic/pharmacodynamic and quality-of-life assessments. Cancer. 2014 Sep 1;120(17):2694-703. doi: 10.1002/cncr.28766. Epub 2014 May 20.