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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: BI 853520

Study type

Interventional

Funder types

Industry

Identifiers

NCT01905111

1300.15

Details and patient eligibility

About

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

Enrollment

21 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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