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

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

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

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: BI 853520

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kashiwa-shi, Chiba, Japan
    • 1300.15.81001 Boehringer Ingelheim Investigational Site
• Taiwan
  • Taipei, Taiwan
    • 1300.15.88601 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 853520; BI 853520 once daily in a dose escalation schedule	Drug: BI 853520; BI 853520 once daily in a dose escalation schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• Doi T, Yang JC, Shitara K, Naito Y, Cheng AL, Sarashina A, Pronk LC, Takeuchi Y, Lin CC. Phase I Study of the Focal Adhesion Kinase Inhibitor BI 853520 in Japanese and Taiwanese Patients with Advanced or Metastatic Solid Tumors. Target Oncol. 2019 Feb;14(1):57-65. doi: 10.1007/s11523-019-00620-0.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 12, 2013
• First Submitted That Met QC Criteria: July 18, 2013
• First Posted (Estimate): July 23, 2013

Study Record Updates

• Last Update Posted (Estimate): September 4, 2014
• Last Update Submitted That Met QC Criteria: September 3, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1300.15