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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: July 24, 2017
Last verified: July 2017
To allow continuation of treatment of patients experiencing benefit from AG 013736

Condition Intervention
Solid Tumors Drug: axitinib

Study Type: Interventional
Study Design: Masking: No masking
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 ]

Secondary Outcome Measures:
  • Secondary safety: Serious adverse events during treatment [ Time Frame: Baseline up to 5 years ]

Enrollment: 52
Actual Study Start Date: March 2003
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (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:   Child, Adult, Senior
Sexes Eligible for Study:   All
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 34 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT00828919     History of Changes
Other Study ID Numbers: A4061008
2005-000051-15 ( EudraCT Number )
Study First Received: January 23, 2009
Last Updated: July 24, 2017

Keywords provided by Pfizer:
VEGFR inhibitor
tyrosine kinase inhibitor

Additional relevant MeSH terms:
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 16, 2017