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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005438-69-ES

Enrollment

Registered

2015-04-27

Start date

2015-07-10

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors MedDRA version: 18.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Onartuzumab (600mg/10ml) Product Code: Ro 549-0258/F01-01 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Onartuzumab CAS Number: 1133766-06-9 Current Spo

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 - To collect safety data with regard to administration of continued onartuzumab therapy;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	—

Measure

Time frame

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 - To collect safety data with regard to administration of continued onartuzumab therapy;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

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

France, Italy, Japan, Korea, Republic of, Latvia, Malaysia, Poland, Russian Federation, Serbia, South Africa, Spain, United States

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd.

global.rochegenentechtrials@roche.com+34913257300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026