Overview

This trial is active, not recruiting.

Condition solid tumor
Treatments control treatment, onartuzumab
Phase phase 3
Target c-MET
Sponsor Hoffmann-La Roche
Start date August 2015
End date August 2017
Trial size 12 participants
Trial identifier NCT02488330, GO29646

Summary

This extension study will provide continued onartuzumab and/or P-trial-designated control treatments to patients 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Placebo Comparator)
Patients will receive treatment with either the control treatment 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).\nOnly patients previously enrolled and currently receiving treatment in the P-trials are eligible for this trial. Patients may be enrolled into the E-trial upon notification from the Sponsor to the investigator that the P-trial is completed.\nAll patients will continue on the same dose and schedule of onartuzumab or control treatment as specified in their respective P-trial. Data will be collected for administration of onartuzumab and any serious adverse event deemed related to onartuzumab treatment and Sponsor manufactured control drugs.
control treatment
Patients on treatment at the completion of the P-trial, defined as when relevant efficacy and safety analyses for the trial are completed by the Sponsor, should be enrolled immediately thereafter into this E-trial. Patients will receive treatment with either the control treatment 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).
(Experimental)
Patients on treatment at the completion of the P-trial, defined as when relevant efficacy and safety analyses for the trial are completed by the Sponsor, should be enrolled immediately thereafter into this E-trial. Patients will receive treatment with either the control treatment 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).\nAll patients will continue on the same dose and schedule of onartuzumab or control treatment as specified in their respective P-trial. Data will be collected for administration of onartuzumab and any serious adverse event deemed related to onartuzumab treatment and Sponsor manufactured control drugs.
onartuzumab
Onartuzumab will be administered intravenously at either a dose of 10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks.\nPatients on treatment at the completion of the P-trial, defined as when relevant efficacy and safety analyses for the trial are completed by the Sponsor, should be enrolled immediately thereafter into this E-trial. Patients will receive treatment with either the control treatment 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).

Primary Outcomes

Measure
Serious adverse events considered related to onartuzumab
time frame: From Day -14 to +30 of cycle 1 (14 or 21-day cycle)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Signed E-trial Informed Consent Form - 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 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 (≥ 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. 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.

Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.