The primary objective of this trial is to explore the safety and tolerability of BI 853520 monotherapy and determine the maximum tolerated dose (MTD) for Japanese and Taiwanese patients with advanced or metastatic solid tumours. Secondary objective is collection of preliminary data on anti-tumour efficacy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
BI 853520 once daily in a dose escalation schedule
1300.15.81001 Boehringer Ingelheim Investigational Site
Kashiwa-shi, Chiba, Japan
1300.15.88601 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Determination of the MTD. It will be defined by the occurrence of dose-limiting toxicities (DLT) during the first treatment cycle of each patient
Time frame: After the first 28 days of treatment
Objective response rate
Time frame: Every 8 weeks until end of study participation, assessed up to 12 months
Disease control rate
Time frame: Every 8 weeks until end of study participation, assessed up to 12 months
Duration of disease control
Time frame: Every 8 weeks until end of study participation, assessed up to 12 months
Tumour shrinkage (in millimetre) defined as the difference between the minimum post-baseline sum of longest diameters of target lesions and the baseline sum of longest diameters of the same set of target lesions
Time frame: Every 8 weeks until end of study participation, assessed up to 12 months
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