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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00828919
Recruitment Status : Active, not recruiting
First Posted : January 26, 2009
Last Update Posted : April 11, 2018
Information provided by (Responsible Party):

Brief Summary:
To allow continuation of treatment of patients experiencing benefit from AG 013736

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: axitinib Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Masking: None (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
Actual Study Start Date : March 2003
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Axitinib
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Secondary safety: Serious adverse events during treatment [ Time Frame: Baseline up to 5 years ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00828919

  Show 34 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT00828919     History of Changes
Other Study ID Numbers: A4061008
2005-000051-15 ( EudraCT Number )
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Keywords provided by Pfizer:
VEGFR inhibitor
tyrosine kinase inhibitor

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