Conditions: Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 69
Healthy volunteers: no

Brief summary:
The aim of the Phase Ia (dose escalation) part of this trial is to assess the maximum tolerated dose (MTD) of BI 847325 administered at escalating doses in 2 treatment arms. In the Phase Ib expansion part of the trial, the aim is to further evaluate the safety profile of BI 847325 at the recommended dose and schedule and to assess target modulation and the potential antitumour efficacy in patients with selected tumour types.

Detailed description:

Arms:
arm 1: 14 days once a day oral intake of BI 847325 followed by 7 days break in 3-week cycles arm 2: 5 days once daily oral intake of BI 847325 followed by 2 days break, repeated every week

Interventions: intervention 1: day 1 to day 5 intervention 2: day 1 to day 14
Intervention descriptions: intervention 1: low to high dose intervention 2: low to high dose

Protocol document: