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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00828919
First received: January 23, 2009
Last updated: October 1, 2014
Last verified: October 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: 36
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

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 22 Study Locations
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, 2005-000051-15
Study First Received: January 23, 2009
Last Updated: October 1, 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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014