CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12 enrolled
Drug / intervention
Onartuzumab +2 moredrug
Likely dose
Onartuzumab 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02488330
NCT02488330Phase 3Completed

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

Hoffmann-La Roche·interventional·Posted Jul 2, 2015·Updated Jul 23, 2019

In Brief

A Phase 3 clinical trial evaluating Onartuzumab, Bevacizumab, and 1 other intervention for Solid Tumor. Completed, enrolled 12 participants across 10 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor
CountriesFrance, Italy, Japan, Latvia, Russia, Serbia, South Africa, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2, 2015
Enrollment StartAug 27, 2015
Primary CompletionJun 29, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11 years ago

Interventions

Onartuzumabdrug

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).

Bevacizumabdrug

All participants will continue on the same dose and schedule of control treatment (bevacizumab) as specified in their respective P-trial.

Erlotinibdrug

All participants will continue on the same dose and schedule of control treatment (erlotinib) as specified in their respective P-trial.