Status:
COMPLETED
A Study of BI 853520 in Japanese and Taiwanese Patients With Various Types of Advanced or Metastatic Cancer
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Neoplasms
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01905111
Start Date
July 1 2013
End Date
August 1 2014
Last Update
September 4 2014
Active Locations (2)
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1
1300.15.81001 Boehringer Ingelheim Investigational Site
Kashiwa-shi, Chiba, Japan
2
1300.15.88601 Boehringer Ingelheim Investigational Site
Taipei, Taiwan