An Extension Study of Onartuzumab in Participants With Solid Tumors on Study Treatment Previously Enrolled in a Company Sponsored Study
This trial is active, not recruiting.
|Treatments||onartuzumab, bevacizumab, erlotinib|
|Start date||August 2015|
|End date||August 2017|
|Trial size||12 participants|
|Trial identifier||NCT02488330, 2014-005438-69, GO29646|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Lille, France||Hopital Roger Salengro||no longer recruiting|
|Lyon, France||Centre Leon Berard||no longer recruiting|
|St Cloud, France||Centre Rene Huguenin; CONSULT SPECIALISEES||no longer recruiting|
|Torino, Italy||Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino||no longer recruiting|
|Ehime, Japan||National Hospital Organization Shikoku Cancer Center||no longer recruiting|
|Riga, Latvia||Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs||no longer recruiting|
|Ivanovo, Russian Federation||Ivanovo Regional Oncology Dispensary||no longer recruiting|
|Kragujevac, Serbia||Clin Hospital Center - Kragujevac; Pulmonary Diseases||no longer recruiting|
|Johannesburg, South Africa||University of the Witwatersrand Research||no longer recruiting|
|Sandton, South Africa||Sandton Oncology Centre||no longer recruiting|
|Barcelona, Spain||Hospital Univ Vall d'Hebron; Servicio de Oncologia||no longer recruiting|
|Madrid, Spain||HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia||no longer recruiting|
|Intervention model||single group assignment|
Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab
time frame: Baseline up to 2 years
All participants at least 18 years old.
Inclusion Criteria: - Enrolled and receiving either control treatment or onartuzumab-based study treatment in an eligible P-trial - Has not met the treatment discontinuation criteria specified in their P-trial protocol at the time of enrollment into the extension trial (E-trial) - Ability to begin treatment in the extension (rollover) protocol within 15 days following the last day of the study in the antecedent protocol - For women who are not postmenopausal (greater than or equal to [>/=] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined non-hormonal contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year during the treatment period and for at least 180 days after the last dose of study drug - For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 180 days after the last dose of study drug and agreement to refrain from donating sperm during this same period Exclusion Criteria: - Pregnancy or lactation or intention to become pregnant during the study (serum pregnancy test required before enrollment) - Any non-protocol anti-cancer therapy started between discontinuation from treatment in P-trial and start of enrollment in E-trial.
|Official title||An Open-label, Multicenter Extension Study of Onartuzumab in Patients With Solid Tumors on Study Treatment Previously Enrolled in an F.Hoffmann-la Roche- and/or Genentech- Sponsored Study|
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