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NCT00828919 Clinical Trial

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

Solid Tumors Clinical Trial

Official title:
CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2, AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN CLINICAL TRIALS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00828919
Other study ID # A4061008
Secondary ID 2005-000051-15
Status Completed
Phase N/A
First received
Last updated
Start date March 7, 2003
Est. completion date August 14, 2023

Study information
Verified date October 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial

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 information / eligibility
Status Completed
Enrollment 52
Est. completion date August 14, 2023
Est. primary completion date August 14, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• axitinib
BID oral tablets. dose of axitinib (AG 013736) will be the same as they were taking in the previous trial
• crizotinib
BID oral Capsules. Dose of crizotinib will be the same taken in previous axitinib trial.

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

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Czechia,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Russian Federation,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Summary of Treatment Emergent Adverse Events (AEs) by Preferred Term Occurring In >20% Patients (All causality) An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Baseline (Day 0) up to 28 days after last dose of study medication
Primary Number of Participants With Treatment Emergent Adverse Events (AEs) (Treatment Related) of axitinib Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Baseline (Day 0) up to 28 days after last dose of study medication
Primary Number of Participants With Treatment Emergent Adverse Events (AEs) (Treatment Related) of crizotinib Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Baseline (Day 0) up to 28 days after last dose of study medication
Primary Summary of Treatment Emergent Serious Adverse Events (SAEs) by Preferred Term (All causality) 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. Baseline (Day 0) up to 28 days after last dose of study medication
Primary Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (Treatment Related) of axitinib 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. Baseline (Day 0) up to 28 days after last dose of study medication
Primary Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (Treatment Related) of crizotinib 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. Baseline (Day 0) up to 28 days after last dose of study medication
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