This extension study will provide continued onartuzumab and/or parent trial (P-trial) designated control treatments to participants with cancer who were previously enrolled in a company-sponsored onartuzumab P-trial and who derived benefit, as assessed by the responsible investigator, from the therapy administered in the P-trial. The study will also collect safety data with regard to administration of continued onartuzumab therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Onartuzumab 10 mg/kg or 15 mg/kg will be administered intravenously on Day 1 of each 14- or 21-day cycle as specified in the P-trial and as per clinical judgment and discretion of the investigator. The actual dose of onartuzumab will be determined on the bases of participants weight at the time of enrollment in extension trial (E-trial).
All participants will continue on the same dose and schedule of control treatment (bevacizumab) as specified in their respective P-trial.
All participants will continue on the same dose and schedule of control treatment (erlotinib) as specified in their respective P-trial.
Hopital Roger Salengro
Lille, France
Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino
Turin, Piedmont, Italy
National Hospital Organization Shikoku Cancer Center
Ehime, Japan
Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Baseline through the end of trial (approximately 3 years)
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Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs
Riga, Latvia
Ivanovo Regional Oncology Dispensary
Ivanovo, Russia
Clin Hospital Center - Kragujevac; Pulmonary Diseases
Kragujevac, Serbia
University of the Witwatersrand Research
Johannesburg, South Africa
Sandton Oncology Medical Group
Sandton, South Africa
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid, Spain