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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: BI 853520

• Registration Number: NCT01905111
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-23
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-03
• Last Update Posted: 2014-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 853520	BI 853520	BI 853520 once daily in a dose escalation schedule

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

1300.15.88601 Boehringer Ingelheim Investigational Site; 🇨🇳 Taipei, Taiwan

1300.15.81001 Boehringer Ingelheim Investigational Site; 🇯🇵 Kashiwa-shi, Chiba, Japan