Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials
NCT00828919
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Patients who were assigned to an axitinib (AG-013736) containing treatment arm in a previous clinical trial
- Patients who were receiving axitinib (AG-013736) 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 axitinib (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
- Patients may not participate in this trial if the conditions for continuing treatment
in the previous axitinib (AG-013736) protocol are not met
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- St. Louis, Missouri
- Sacramento, California
- Chicago, Illinois
- Birmingham, Alabama
- Birmingham, Alabama
- Birmingham, Alabama
- Los Angeles, California
- Los Angeles, California
- San Francisco, California
- San Francisco, California
- Santa Monica,, California
- Aurora, Colorado
- Indianapolis, Indiana
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Ann Arbor, Michigan
- Detroit, Michigan
- Farmington Hills, Michigan
- Minneapolis, Minnesota
- St. Louis, Missouri
- Albuquerque, New Mexico
- Albuqurque, New Mexico
- New York, New York
- New York, New York
- New York, New York
- Durham, North Carolina
- Cleveland, Ohio
- Philadelphia, Pennsylvania
- Myrtle Beach, South Carolina
- Franklin, Tennessee
- Gallatin, Tennessee
- Hermitage, Tennessee
- Lebanon, Tennessee
- Murfreesboro, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Smyrna, Tennessee
- Dallas, Texas
- Houston, Texas
- Madison, Wisconsin
- Randwick, New South Wales
- East Melbourne, Victoria
- Heidelberg, Victoria
- Montreal, Quebec
- Villejuif Cedex,
- Thessaloniki,
- Milano,
- Milano,
- Nijmegen, Gld
- Singapore,
- Lund,
- Stockholm,
- St. Gallen,
- Leeds,
- London,
- London,
- Newcastle-Upon-Tyne,
Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title ICMJE | Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials | ||||
Official Title ICMJE | CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2, AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN CLINICAL TRIALS | ||||
Brief Summary | To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial | ||||
Detailed Description | This is a roll over study aimed to provide continued access to axitinib (monotherapy or combination, according to treatment received in prior axitinib study) to patients who have documented stable, or responding disease, or received clinical benefit (as defined by protocol) at the time of the prior study closure. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model Description: This is a continuing access, open label study for patients to receive monotherapy or combination therapy based on previous treatment received in parent protocol Masking: None (Open Label)Primary Purpose: Treatment | ||||
Condition ICMJE | Solid Tumors | ||||
Intervention ICMJE |
| ||||
Study Arms ICMJE | Experimental: Treatment
Patients continue the same treatment (axitinib monotherapy or in combination with crizotinib) as in prior axitinib study Interventions:
| ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE | 52 | ||||
Original Estimated Enrollment ICMJE | 100 | ||||
Estimated Study Completion Date ICMJE | May 1, 2022 | ||||
Estimated Primary Completion Date | May 1, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Sex/Gender ICMJE |
| ||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Czechia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Russian Federation, Taiwan, United Kingdom, United States | ||||
Removed Location Countries | Czech Republic | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00828919 | ||||
Other Study ID Numbers ICMJE | A4061008 2005-000051-15 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
| ||||
PRS Account | Pfizer | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |