An Extension Study of Onartuzumab in Participants With Solid Tumors on Study Treatment Previously Enrolled in a Company Sponsored Study

Solid Tumor Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488330
• Other study ID #: GO29646
• Secondary ID: 2014-005438-69
• Status: Completed
• Phase: Phase 3
• Start date: August 27, 2015
• Est. completion date: June 29, 2018

Study information

• Verified date: July 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 29, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• Onartuzumab
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).
• Bevacizumab
All participants will continue on the same dose and schedule of control treatment (bevacizumab) as specified in their respective P-trial.
• Erlotinib
All participants will continue on the same dose and schedule of control treatment (erlotinib) as specified in their respective P-trial.

Locations

Country	Name	City	State
France	Hopital Roger Salengro	Lille
Italy	Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino	Torino	Piemonte
Japan	National Hospital Organization Shikoku Cancer Center	Ehime
Latvia	Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs	Riga
Russian Federation	Ivanovo Regional Oncology Dispensary	Ivanovo
Serbia	Clin Hospital Center - Kragujevac; Pulmonary Diseases	Kragujevac
South Africa	University of the Witwatersrand Research	Johannesburg
South Africa	Sandton Oncology Medical Group	Sandton
Spain	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Barcelona
Spain	HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

France,  Italy,  Japan,  Latvia,  Russian Federation,  Serbia,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline through the end of trial (approximately 3 years)