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

NCT ID: NCT01905111

Last Updated: 2014-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-08-31

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

Conditions

Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BI 853520

BI 853520 once daily in a dose escalation schedule

Group Type: EXPERIMENTAL

BI 853520

Intervention Type: DRUG

BI 853520 once daily in a dose escalation schedule

Interventions

BI 853520

BI 853520 once daily in a dose escalation schedule

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1300.15.81001 Boehringer Ingelheim Investigational Site

Kashiwa-shi, Chiba, , Japan

1300.15.88601 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Countries

Japan; Taiwan

References

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.

Reference Type: DERIVED

PMID: 30725402 (View on PubMed)

Other Identifiers

1300.15

Identifier Type: -

Identifier Source: org_study_id