Last updated on February 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 the Maximum Tolerated Dose (MTD) of BI 894999 administered at escalating doses in two treatment schedules (schedule A of continuous dosing, schedule B with two weeks on treatment followed by one week off in 3-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 recommended dose and schedule in patients with solid tumours and to assess target modulation and the potential antitumour efficacy in patients with selected types of tumours. Once the MTD has been determined for both schedules in patients with solid tumours, the MTD will be determined as well in patients with diffuse large B-cell lymphoma (DLBCL), using the recommended schedule for solid tumours.The PK profile will be determined from the first cycle in all patients in both phases.

Clinical Study Identifier: NCT02516553

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Boehringer Ingelheim Call Center

INS Gustave Roussy
Villejuif, France
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Recruitment Status: Open

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