Overview

Condition solid tumor
Treatments onartuzumab, bevacizumab, erlotinib
Phase phase 3
Target c-MET
Sponsor Hoffmann-La Roche
Start date August 2015
End date August 2017
Trial size 17 participants
Trial identifier NCT02488330, 2014-005438-69, GO29646

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.

Recruiting in the following locations…

United States No locations recruiting
Other countries France, Italy, Latvia, Russian Federation, South Africa, and Spain

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
Participants will receive treatment with either the control treatment (erlotinib, bevacizumab) and/or onartuzumab-based study treatment (as during their P-trial) until progression of disease, unacceptable treatment related toxicity, withdrawal of consent, or death (whichever occurs first). All participants will continue on the same dose and schedule of control treatment as specified in their respective P-trial. The dose of onartuzumab will be calculated based on the participant's weight at the screening visit for the E-trial.
onartuzumab
Onartuzumab 10 mg/kg or 15 mg/kg will be administered intravenously on Day 1 of each 14- or 21-day cycle as specified in the P-trial and as per clinical judgment and discretion of the investigator. The actual dose of onartuzumab will be determined on the bases of participants weight at the time of enrollment in extension trial (E-trial).
bevacizumab Avastin
All participants will continue on the same dose and schedule of control treatment (bevacizumab) as specified in their respective P-trial.
erlotinib Tarceva
All participants will continue on the same dose and schedule of control treatment (erlotinib) as specified in their respective P-trial.

Primary Outcomes

Measure
Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab
time frame: Baseline up to 2 years

Eligibility Criteria

All participants at least 18 years old.

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.

Additional Information

Official 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
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.