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

Not Applicable

Completed

Conditions: Solid Tumors

Interventions: Drug: axitinib
Drug: crizotinib

Registration Number: NCT00828919

Lead Sponsor: Pfizer

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 52

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	axitinib	Patients continue the same treatment (axitinib monotherapy or in combination with crizotinib) as in prior axitinib study
Treatment	crizotinib	Patients continue the same treatment (axitinib monotherapy or in combination with crizotinib) as in prior axitinib study

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs	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)	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (33): Fondazione IRCCS, Istituto Nazionale Tumori, S.S.D Oncologia Medica dei Tumori testa-collo
🇮🇹
Milano, Italy
Nemocnice Na Bulovce
🇨🇿
Praha, Czechia
Hopital de la Pitie Salpetriere
🇫🇷
Paris Cedex 13, France
Chiba Cancer Center
🇯🇵
Chiba, Japan
Kyushu University Hospital
🇯🇵
Fukuoka, Japan
Fondazione IRCCS, Istituto Nazionale Tumori, Laboratorio
🇮🇹
Milano, Italy
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
🇭🇺
Budapest, Hungary
FSBSI "N.N. Blokhin Russian Cancer Research Center"
🇷🇺
Moscow, Russian Federation
Kinki University Hospital
🇯🇵
Osakasayama, Osaka, Japan
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸
San Francisco, California, United States
Charité - Universitaetsmedizin Berlin, Charité Campus Mitte
🇩🇪
Berlin, Germany
Nottingham City Hospital / Oncology Department
🇬🇧
Nottingham, United Kingdom
Fakultni nemocnice Olomouc
🇨🇿
Olomouc, Czech Republic, Czechia
The University of Texas M.D. Anderson Cancer Center
🇺🇸
Houston, Texas, United States
University of Chicago Hospitals
🇺🇸
Chicago, Illinois, United States
Johns Hopkins University
🇺🇸
Baltimore, Maryland, United States
The Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Taichung Veterans General Hospital
🇨🇳
Taichung, Taiwan
Memorial Sloan-Kettering Cancer Center
🇺🇸
New York, New York, United States
The University of Texas MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States
Nagasaki University Hospital
🇯🇵
Nagasaki, Japan
UCLA Hematology-Oncology-Santa Monica
🇺🇸
Santa Monica, California, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
🇺🇸
Baltimore, Maryland, United States
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
🇺🇸
Orange, California, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
Fox Chase Cancer Center
🇺🇸
Philadelphia, Pennsylvania, United States
National Cancer Center Hospital East
🇯🇵
Kashiwa, Tiba, Japan
Samsung Medical Center
🇰🇷
Seoul, Korea, Republic of
University of Michigan Health System
🇺🇸
Ann Arbor, Michigan, United States
Providence Regional Medical Center Everett
🇺🇸
Everett, Washington, United States
Providence Regional Medical Center Everett - Providence Regional Cancer Partnership
🇺🇸
Everett, Washington, United States
UC Irvine Medical Center
🇺🇸
Orange, California, United States
University of Wisconsin - Hospital and Clinics
🇺🇸
Madison, Wisconsin, United States