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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00389441
Recruitment Status : Completed
First Posted : October 18, 2006
Results First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Thyroid Neoplasms Drug: AG-013736 Phase 2

Detailed Description:
Additional study details: assess safety and efficacy

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Start Date : December 2006
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Axitinib

Arm Intervention/treatment
Experimental: A Drug: AG-013736
AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity




Primary Outcome Measures :
  1. 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) ]
    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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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 ]
    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).

  4. 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) ]
    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.

  5. 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) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389441


Locations
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United States, California
Pfizer Investigational Site
Orange, California, United States, 92868
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80010
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33612
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637-1470
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67226
Pfizer Investigational Site
Witchita, Kansas, United States, 67220
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
United States, New York
Pfizer Investigational Site
Buffalo, New York, United States, 14263
Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6A 4L6
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H2L 4M1
China, Jiangsu
Pfizer Investigational Site
Nanjing, Jiangsu, China, 210002
China
Pfizer Investigational Site
Beijing, China, 100021
Pfizer Investigational Site
Shanghai, China, 20001/200127
Pfizer Investigational Site
Shanghai, China, 200233
Czech Republic
Pfizer Investigational Site
Praha 5, Czech Republic, 150 06
India
Pfizer Investigational Site
Vellore, Tamil Nadu, India, 632 004
Italy
Pfizer Investigational Site
Milano, Italy, 20133
Pfizer Investigational Site
Pisa, Italy, 56124
Poland
Pfizer Investigational Site
Gliwice, Poland, 44-101
Pfizer Investigational Site
Warszawa, Poland, 02-781
Spain
Pfizer Investigational Site
Pamplona, Navarra, Spain, 31008
Pfizer Investigational Site
Madrid, Spain, 28033
United Kingdom
Pfizer Investigational Site
Glasgow, United Kingdom, G12 0YN
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00389441    
Other Study ID Numbers: A4061027
First Posted: October 18, 2006    Key Record Dates
Results First Posted: November 25, 2013
Last Update Posted: November 25, 2013
Last Verified: September 2013
Keywords provided by Pfizer:
VEGFR inhibitor
tyrosine kinase inhibitor
anti-angiogenic
carcinoma
papillary
follicular
medullary
anaplastic
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Axitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action