Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer

Thyroid Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389441
• Other study ID #: A4061027
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2006
• Last updated: September 24, 2013
• Start date: December 2006
• Est. completion date: September 2012

Study information

• Verified date: September 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

Additional study details: assess safety and efficacy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• AG-013736
AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Nanjing	Jiangsu
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Shanghai
Czech Republic	Pfizer Investigational Site	Praha 5
India	Pfizer Investigational Site	Vellore	Tamil Nadu
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Pisa
Poland	Pfizer Investigational Site	Gliwice
Poland	Pfizer Investigational Site	Warszawa
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Pamplona	Navarra
United Kingdom	Pfizer Investigational Site	Glasgow
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Witchita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  China,  Czech Republic,  India,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Objective Response (OR)	Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST). CR: disappearance of all target/non-target lesions and no appearance of new lesions. PR: at least (>=)30 percent(%) decrease in sum of the longest dimensions (LDs) of the target lesions (taking as a reference the baseline sum), without progression of non-target lesions and no appearance of new lesions. Confirmed responses: those persist on repeat imaging study >=4 weeks after initial documentation of response.	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)	No
Secondary	Progression Free Survival (PFS)	PFS: Time in weeks from the start of study treatment to first documentation of objective disease progression or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study treatment plus 1) divided by 7. Progression is defined using RECIST, as >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since start of study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.	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)	No
Secondary	Duration of Response (DR)	Time in weeks 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 any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.	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)	No
Secondary	Overall Survival (OS)	Time in weeks 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) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).	Baseline to death due to any cause or at least 2 year after the first dose for the last participant	No
Secondary	Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score	Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.	Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)	No
Secondary	Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score	Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life). Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Total average score range: 0 to 10. Lower scores indicated better outcome.	Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)	No

External Links

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