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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00828919
First received: January 23, 2009
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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: 10 Oct 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary safety: Serious adverse events during treatment [ Time Frame: 10 Oct 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2003
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: February 2015 (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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00828919

Locations
United States, California
Pfizer Investigational Site
Orange, California, United States, 92868
Pfizer Investigational Site
San Francisco, California, United States, 94115
Pfizer Investigational Site
Santa Monica, California, United States, 90404
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21231
Pfizer Investigational Site
Baltimore, Maryland, United States, 21205
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
Pfizer Investigational Site
New York, New York, United States, 10022
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Washington
Pfizer Investigational Site
Everett, Washington, United States, 98201
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792
France
Pfizer Investigational Site
Paris Cedex 13, France, 75651
Germany
Pfizer Investigational Site
Berlin, Germany, 10117
Italy
Pfizer Investigational Site
Milano, Italy, 20133
Japan
Pfizer Investigational Site
Kashiwa, Tiba, Japan
United Kingdom
Pfizer Investigational Site
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00828919     History of Changes
Other Study ID Numbers: A4061008
Study First Received: January 23, 2009
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
VEGFR inhibitor
angi-angiogenic
tyrosine kinase inhibitor

Additional relevant MeSH terms:
Axitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014