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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02488330
• Date of registration: 30/06/2015
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: An Extension Study of Onartuzumab in Participants With Solid Tumors on Study Treatment Previously Enrolled in a Company Sponsored 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: August 27, 2015
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02488330
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Solid Tumor

Intervention(s)

Drug: Erlotinib

Drug: Bevacizumab

Drug: Onartuzumab

Primary Outcome(s)

Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab [Time Frame: Baseline through the end of trial (approximately 3 years)]

Secondary ID(s)

GO29646

2014-005438-69

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02488330