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: May 1, 2016
Last verified: May 2016
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: 53
Study Start Date: March 2003
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2017 (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 to 99 Years
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 
Study First Received: January 23, 2009
Last Updated: May 1, 2016
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 May 04, 2016