An Extension Study of Onartuzumab in Patients With Solid Tumors on Study Treatment Previously Enrolled in a Company Sponsored Study
This trial is active, not recruiting.
|Treatments||control treatment, onartuzumab|
|Start date||August 2015|
|End date||August 2017|
|Trial size||12 participants|
|Trial identifier||NCT02488330, GO29646|
This extension study will provide continued onartuzumab and/or P-trial-designated control treatments to patients 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 59037||not available||no longer recruiting|
|Lyon, France 69008||not available||no longer recruiting|
|St Cloud, France 92210||not available||no longer recruiting|
|Torino, Italy 10126||not available||no longer recruiting|
|Ehime, Japan 791-0280||not available||no longer recruiting|
|Riga, Latvia LV 1079||not available||no longer recruiting|
|Ivanovo, Russian Federation 153040||not available||no longer recruiting|
|Kragujevac, Serbia 34000||not available||no longer recruiting|
|Johannesburg, South Africa 2193||not available||no longer recruiting|
|Sandton, South Africa 2196||not available||no longer recruiting|
|Barcelona, Spain 08035||not available||no longer recruiting|
|Madrid, Spain 28050||not available||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
Serious adverse events considered related to onartuzumab
time frame: From Day -14 to +30 of cycle 1 (14 or 21-day cycle)
Male or female participants at least 18 years old.
Inclusion Criteria: - Signed E-trial Informed Consent Form - 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 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 (≥ 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 < 1% per year during the treatment period and for at least 90 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 90 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.
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