An Extension Study of Onartuzumab in Patients with Solid Tumors at the end of a F. Hoffmann-La Roche and/or Genentech Sponsored Onartuzumab Parent Study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 21

Inclusion Criteria

- Enrolled and receiving either control treatment or onartuzumab-based study treatment in an eligible P study
- Has not met the treatment discontinuation criteria specified in their P study protocol at the time of enrollment into the extension study (E study)
- Ability to begin treatment in the extension (rollover) protocol within 15 days following the last day of the parent study
- 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

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 study and start of enrollment in E study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To provide continued onartuzumab and/or parent study (P study)-designated control treatments to patients with cancer who were previously enrolled in a Roche/Genentech-sponsored onartuzumab P study and who derived benefit, as assessed by the responsible investigator, from the therapy administered in the P study<br>•To collect safety data with regard to administration of continued onartuzumab therapy<br>;Secondary Objective: Not applicable;Primary end point(s): Incidence of serious adverse events considered related to onartuzumab;Timepoint(s) of evaluation of this end point: Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

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