At a glance
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An Open-label Phase I Dose Escalation Trial of Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours
In Brief
A Phase 1 clinical trial evaluating 750 milligram Xentuzumab, 1000 milligram Xentuzumab, and 1 other intervention for Neoplasms. Completed, enrolled 21 participants across 1 site.
Detailed Summary
This open-label dose escalation phase I trial, 1280.15, is with the first administration of BI 836845 in Japanese patients with various types of advanced solid tumours. The rationale behind this study is to identify the maximum tolerated dose (MTD) of BI 836845 in Japanese patients with advanced solid tumours as weekly intravenous administration.
Study Details
Timeline
Interventions
750 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.
1000 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.
1400 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.