Continuing Access To AG- 013736 (A406) For Patients Previously Receiving AG 013736 In Clinical Trials
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00828919
First received: January 23, 2009
Last updated: May 7, 2013
Last verified: May 2013
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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: | December 2015 |
| Estimated Primary Completion Date: | January 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828919
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | |
| Contact: Pfizer Oncology Clinical Trial Information Service | 1-877-369-9753 | PfizerCancerTrials@emergingmed.com |
Locations
| United States, California | |
| Pfizer Investigational Site | Recruiting |
| Orange, California, United States, 92868 | |
| Pfizer Investigational Site | Recruiting |
| San Francisco, California, United States, 94115 | |
| Pfizer Investigational Site | Completed |
| Santa Monica,, California, United States, 90404 | |
| United States, Illinois | |
| Pfizer Investigational Site | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| United States, Maryland | |
| Pfizer Investigational Site | Completed |
| Baltimore, Maryland, United States, 21231 | |
| Pfizer Investigational Site | Completed |
| Baltimore, Maryland, United States, 21205 | |
| United States, Michigan | |
| Pfizer Investigational Site | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, New York | |
| Pfizer Investigational Site | Completed |
| New York, New York, United States, 10021 | |
| Pfizer Investigational Site | Completed |
| New York, New York, United States, 10022 | |
| United States, Ohio | |
| Pfizer Investigational Site | Completed |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| United States, Texas | |
| Pfizer Investigational Site | Completed |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Pfizer Investigational Site | Recruiting |
| Everett, Washington, United States, 98201 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | Completed |
| Madison, Wisconsin, United States, 53792 | |
| France | |
| Pfizer Investigational Site | Completed |
| Paris Cedex 13, France, 75651 | |
| Germany | |
| Pfizer Investigational Site | Completed |
| Berlin, Germany, 10117 | |
| Italy | |
| Pfizer Investigational Site | Recruiting |
| Milano, Italy, 20133 | |
| Japan | |
| Pfizer Investigational Site | Completed |
| Kashiwa, Tiba, Japan | |
| United Kingdom | |
| Pfizer Investigational Site | Completed |
| 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: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
VEGFR inhibitor angi-angiogenic tyrosine kinase inhibitor |
ClinicalTrials.gov processed this record on May 23, 2013