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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905111
• Other study ID #: 1300.15
• Status: Completed
• Phase: Phase 1
• First received: July 12, 2013
• Last updated: September 3, 2014
• Start date: July 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareTaiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• BI 853520
BI 853520 once daily in a dose escalation schedule

Locations

Country	Name	City	State
Japan	1300.15.81001 Boehringer Ingelheim Investigational Site	Kashiwa-shi, Chiba
Taiwan	1300.15.88601 Boehringer Ingelheim Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Japan,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Objective response rate		Every 8 weeks until end of study participation, assessed up to 12 months	No
Secondary	Disease control rate		Every 8 weeks until end of study participation, assessed up to 12 months	No
Secondary	Duration of disease control		Every 8 weeks until end of study participation, assessed up to 12 months	No
Secondary	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	No