Last updated on August 2019

BI 894999 First in Human Dose Finding Study in Advanced Malignancies


Brief description of study

The aim of the phase Ia (dose escalation) part of this trial is to assess-> determine the Maximum Tolerated Dose (MTD) using a continuous dosing schedule A, using an intermittent Schedule B (2 weeks on, one week off in 3-week cycles) and the MTD using an intermittent Schedule C (one week on followed by one week off treatment, repeated every two weeks in 4-week cycles) in patients with solid tumours.

In the phase Ib expansion part, the aim is to further evaluate the safety profile of BI 894999 at the dose recommended by the data monitoring committee (DMC). Once the MTD has been determined for both schedules A and B in patients with solid tumours, the MTD will be determined as well in patients with diffuse large B-cell lymphoma (DLBCL), using the DMC recommended schedule for solid tumours

Clinical Study Identifier: NCT02516553

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INS Gustave Roussy

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