A Study of BI 853520 in Japanese and Taiwanese Patients With Various Types of Advanced or Metastatic Cancer

Study Overview
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Brief Summary
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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

Official Title
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An Open-label Phase I Dose Finding Study of BI 853520 Administered Orally in a Continuous Dosing Schedule in Japanese and Taiwanese Patients With Various Advanced or Metastatic Solid Tumours

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: BI 853520


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 853520<br>BI 853520 once daily in a dose escalation schedule | Drug: BI 853520<br>* BI 853520 once daily in a dose escalation schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |