Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer
September 24, 2013 updated by: Pfizer
A Pivotal Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With 131I-Refractory Metastatic Or Unresectable Locally-Advanced Thyroid Cancer
The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer that is resistant to radioactive iodine
Study Overview
Detailed Description
Additional study details: assess safety and efficacy
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Pfizer Investigational Site
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Ontario
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London, Ontario, Canada, N6A 4L6
- Pfizer Investigational Site
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
- Pfizer Investigational Site
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Beijing, China, 100021
- Pfizer Investigational Site
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Shanghai, China, 200233
- Pfizer Investigational Site
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Shanghai, China, 20001/200127
- Pfizer Investigational Site
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Jiangsu
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Nanjing, Jiangsu, China, 210002
- Pfizer Investigational Site
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Praha 5, Czech Republic, 150 06
- Pfizer Investigational Site
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Tamil Nadu
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Vellore, Tamil Nadu, India, 632 004
- Pfizer Investigational Site
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Milano, Italy, 20133
- Pfizer Investigational Site
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Pisa, Italy, 56124
- Pfizer Investigational Site
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Gliwice, Poland, 44-101
- Pfizer Investigational Site
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Warszawa, Poland, 02-781
- Pfizer Investigational Site
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Madrid, Spain, 28033
- Pfizer Investigational Site
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Navarra
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Pamplona, Navarra, Spain, 31008
- Pfizer Investigational Site
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Glasgow, United Kingdom, G12 0YN
- Pfizer Investigational Site
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California
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Orange, California, United States, 92868
- Pfizer Investigational Site
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Colorado
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Aurora, Colorado, United States, 80010
- Pfizer Investigational Site
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Florida
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Tampa, Florida, United States, 33612
- Pfizer Investigational Site
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Illinois
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Chicago, Illinois, United States, 60637-1470
- Pfizer Investigational Site
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Kansas
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Wichita, Kansas, United States, 67226
- Pfizer Investigational Site
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Witchita, Kansas, United States, 67220
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Pfizer Investigational Site
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Boston, Massachusetts, United States, 02115
- Pfizer Investigational Site
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Boston, Massachusetts, United States, 02215
- Pfizer Investigational Site
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New York
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Buffalo, New York, United States, 14263
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A
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AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Objective Response (OR)
Time Frame: 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)
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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.
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression Free Survival (PFS)
Time Frame: 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)
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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.
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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)
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Duration of Response (DR)
Time Frame: 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)
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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.
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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)
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Overall Survival (OS)
Time Frame: Baseline to death due to any cause or at least 2 year after the first dose for the last participant
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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).
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Baseline to death due to any cause or at least 2 year after the first dose for the last participant
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Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score
Time Frame: Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)
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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.
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Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)
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Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score
Time Frame: Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)
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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.
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Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
October 16, 2006
First Submitted That Met QC Criteria
October 17, 2006
First Posted (Estimate)
October 18, 2006
Study Record Updates
Last Update Posted (Estimate)
November 25, 2013
Last Update Submitted That Met QC Criteria
September 24, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A4061027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.