Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials
CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2, AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN CLINICAL TRIALS
2 other identifiers
interventional
52
11 countries
34
Brief Summary
To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2003
Longer than P75 for not_applicable
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2003
CompletedFirst Submitted
Initial submission to the registry
January 23, 2009
CompletedFirst Posted
Study publicly available on registry
January 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2023
CompletedResults Posted
Study results publicly available
December 3, 2024
CompletedDecember 3, 2024
November 1, 2024
20.5 years
January 23, 2009
July 16, 2024
November 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness of an AE to study drug was based on investigator's assessment. AEs included both serious and non-serious AEs.
Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow-up to approximately 120.56 months)
Study Arms (1)
Treatment
EXPERIMENTALPatients continue the same treatment (axitinib monotherapy or in combination with crizotinib) as in prior axitinib study
Interventions
BID oral tablets. dose of axitinib (AG 013736) will be the same as they were taking in the previous trial
BID oral Capsules. Dose of crizotinib will be the same taken in previous axitinib trial.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients may not participate in this trial if the conditions for continuing treatment in the previous axitinib (AG-013736) protocol are not met
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (34)
UC Irvine Medical Center
Orange, California, 92868, United States
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
UCLA Hematology-Oncology-Santa Monica
Santa Monica, California, 90404, United States
University of Chicago Hospitals
Chicago, Illinois, 60637, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10022, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Providence Regional Medical Center Everett - Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
University of Wisconsin - Hospital and Clinics
Madison, Wisconsin, 53792, United States
Fakultni nemocnice Olomouc
Olomouc, Czech Republic, 77900, Czechia
Nemocnice Na Bulovce
Prague, 18081, Czechia
Hopital de la Pitie Salpetriere
Paris, 75651, France
Charité - Universitaetsmedizin Berlin, Charité Campus Mitte
Berlin, 10117, Germany
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
Budapest, 1083, Hungary
Fondazione IRCCS, Istituto Nazionale Tumori, Laboratorio
Milan, 20133, Italy
Fondazione IRCCS, Istituto Nazionale Tumori, S.S.D Oncologia Medica dei Tumori testa-collo
Milan, 20133, Italy
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Kinki University Hospital
Sayama, Osaka, 589-8511, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
FSBSI "N.N. Blokhin Russian Cancer Research Center"
Moscow, Russian Federation, 115478, Russia
Samsung Medical Center
Seoul, 06351, South Korea
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Nottingham City Hospital / Oncology Department
Nottingham, NG5 1PB, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2009
First Posted
January 26, 2009
Study Start
March 7, 2003
Primary Completion
August 14, 2023
Study Completion
August 14, 2023
Last Updated
December 3, 2024
Results First Posted
December 3, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.