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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00389441
First received: October 16, 2006
Last updated: October 11, 2012
Last verified: October 2012
History of Changes

October 16, 2006
October 11, 2012
December 2006
September 2012   (final data collection date for primary outcome measure)
Objective response rate (ORR) according to RECIST criteria [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Objective response rate (ORR) according to RECIST criteria
Complete list of historical versions of study NCT00389441 on ClinicalTrials.gov Archive Site
  • Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Duration of response (DR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Patient reported outcome: MD Anderson Symptom Inventory (MDASI) questionnaire [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety profile of AG0013736: Safety profile characterized by type, grade and frequency of all adverse events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety profile of AG0013736: Safety profile characterized by laboratory abnormalities [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Safety profile of AG 013736 Progression-free survival (PFS) Duration of response (DR) Overall survival (OS) Patient reported outcomes (PRO)
Not Provided
Not Provided
 
Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer
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

Additional study details: assess safety and efficacy
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Thyroid Neoplasms
Drug: AG-013736
AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity
Experimental: A
Intervention: Drug: AG-013736
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   China,   Czech Republic,   India,   Italy,   Poland,   Spain,   United Kingdom
 
NCT00389441
A4061027
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP