Clinical trial NCT02488330: An Extension Study of Onartuzumab in Participants With Solid Tumors on Study Treatment Previously Enrolled in a Company Sponsored Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Solid Tumor
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-07-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab
timeFrame: Baseline through the end of trial (approximately 3 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro
city: Torino
country: Italy
facility: Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino
state: Piemonte
city: Ehime
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Riga
country: Latvia
facility: Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Kragujevac
country: Serbia
facility: Clin Hospital Center - Kragujevac; Pulmonary Diseases
city: Johannesburg
country: South Africa
facility: University of the Witwatersrand Research
city: Sandton
country: South Africa
facility: Sandton Oncology Medical Group
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
city: Madrid
country: Spain
facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: