Clinical trial NCT00828919: Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials
Official title: CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2, AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN CLINICAL TRIALS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Tumors
Keywords: VEGFR inhibitor
angi-angiogenic
tyrosine kinase inhibitor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
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
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients may not participate in this trial if the conditions for continuing treatment in the previous axitinib (AG-013736) protocol are not met

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology-Oncology-Santa Monica
state: California
city: Chicago
country: United States
facility: University of Chicago Hospitals
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Everett
country: United States
facility: Providence Regional Medical Center Everett - Providence Regional Cancer Partnership
state: Washington
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Madison
country: United States
facility: University of Wisconsin - Hospital and Clinics
state: Wisconsin
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
state: Czech Republic
city: Praha
country: Czechia
facility: Nemocnice Na Bulovce
city: Paris Cedex 13
country: France
facility: Hopital de la Pitie Salpetriere
city: Berlin
country: Germany
facility: Charité - Universitaetsmedizin Berlin, Charité Campus Mitte
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar
city: Milano
country: Italy
facility: Fondazione IRCCS, Istituto Nazionale Tumori, Laboratorio
city: Milano
country: Italy
facility: Fondazione IRCCS, Istituto Nazionale Tumori, S.S.D Oncologia Medica dei Tumori testa-collo
city: Osakasayama
country: Japan
facility: Kinki University Hospital
state: Osaka
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Tiba
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Moscow
country: Russian Federation
facility: FSBSI "N.N. Blokhin Russian Cancer Research Center"
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital / Oncology Department
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: