Continuing Access To AG- 013736 (A406) For Patients Previously Receiving AG 013736 In Clinical Trials

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: January 23, 2009
Last updated: August 10, 2015
Last verified: August 2015

To allow continuation of treatment of patients experiencing benefit from AG 013736

Condition Intervention
Solid Tumors
Drug: axitinib

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuing Access To The Tyrosine Kinase Inhibitor Of VEGFR 2, AG 013736 (A406) For Patients Previously Receiving AG 013736 In Clinical Trials

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety, especially thyroid gland abnormalities will be assessed using regular measurements of thyroid stimulating hormone in blood. [ Time Frame: Baseline up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary safety: Serious adverse events during treatment [ Time Frame: Baseline up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: March 2003
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
axitinib Drug: axitinib
BID oral tablets. dose of AG 013736 will be the same as they were taking in the previous trial
Other Name: AG-013736


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who were assigned to an axitinib containing treatment arm in a previous clinical trial
  • Patients who were receiving axitinib tablets at the time their previous trial ended
  • Patients who have stable (SD) or responding disease (PR or CR) documented by the appropriate radiological, clinical, or laboratory assessments within 12 weeks before enrollment (Note: response criteria from the previous AG-013736 protocol should be used to determine stable or responding disease).
  • Patients who have progressive disease (PD) but have experienced "clinical benefit" as defined in the study protocol

Exclusion Criteria:

  • Patients may not participate in this trial if the conditions for continuing treatment in the previous AG-013736 protocol are not met
  Contacts and Locations
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Please refer to this study by its identifier: NCT00828919

  Show 23 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT00828919     History of Changes
Other Study ID Numbers: A4061008, 2005-000051-15
Study First Received: January 23, 2009
Last Updated: August 10, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
VEGFR inhibitor
tyrosine kinase inhibitor

Additional relevant MeSH terms:
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors processed this record on October 09, 2015