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

• Register: EUCTR
• Last refreshed on: 3 September 2018
• Main ID: EUCTR2014-005438-69-LV
• Date of registration: 19/05/2015
• Prospective Registration: Yes
• Primary sponsor: F. Hoffman-La Roche Ltd.
• Public title: 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
• Scientific 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
• Date of first enrolment: 01/06/2015
• Target sample size: 21
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005438-69
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd.

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd.

Key inclusion & exclusion 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 <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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

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 Sponsor code: RO5490258/PRO143966
Other descriptive name: ONARTUZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-

Trade Name: Tarceva®
Product Code: RO050-8231/V03-05
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ERLOTINIB
CAS Number: 183321-74-6
Current Sponsor code: RO050-8231
Other descriptive name: erlotinib hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: Tarceva®
Product Code: RO050-8231/V02-05
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ERLOTINIB
CAS Number: 183321-74-6
Current Sponsor code: RO050-8231
Other descriptive name: erlotinib hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Avastin®
Product Name: Bevacizumab
Product Code: RO4876646/F02
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Current Sponsor code: RO4876646
Other descriptive name: rhuMAb VEGF, anti-VEGF
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Primary end point(s): Incidence of serious adverse events considered related to onartuzumab

Secondary Objective: Not applicable

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

Timepoint(s) of evaluation of this end point: Up to 2 years

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

2014-005438-69-ES

GO29646

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd.