Phase 3
Completed N=12
An Extension Study of Onartuzumab in Participants With Solid Tumors on Study Treatment Previously Enrolled in a Company Sponsored Study
Source: ClinicalTrials.gov NCT02488330 ↗Enrolled (actual)
12
Serious AEs
41.7%
Results posted
Jul 2019
Primary outcomePrimary: Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab — 0 Percent
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab |
— | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02488330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.