Neoplasms
Conditions
Brief summary
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
Interventions
DRUGBI 853520
BI 853520 once daily in a dose escalation schedule
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a confirmed diagnosis of advanced, measurable or evaluable, non-resectable and/or metastatic non-hematologic malignancy, which has shown to be progressive in the last 6 months * Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options * Recovery from reversible toxicities (alopecia excluded) of prior anti-cancer therapies (Common Terminology Criteria for Adverse Events grade \<2) * Age \>= 20 years * Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation * Eastern Cooperative Oncology Group (ECOG), performance score 0-1
Exclusion criteria
* Serious concomitant non-oncological disease/illness * Active/symptomatic brain metastases * Second malignancy * Pregnancy or breastfeeding * Women or men who are sexually active and unwilling to use a medically acceptable method of contraception. * Treatment with cytotoxic anti-cancer-therapies or investigational drugs within four weeks of the first treatment with the study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the MTD. It will be defined by the occurrence of dose-limiting toxicities (DLT) during the first treatment cycle of each patient | After the first 28 days of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate | Every 8 weeks until end of study participation, assessed up to 12 months |
| Disease control rate | Every 8 weeks until end of study participation, assessed up to 12 months |
| Duration of disease control | 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 | Every 8 weeks until end of study participation, assessed up to 12 months |
Countries
Japan, Taiwan
Outcome results
None listed