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CompletedNCT01905111Updated Sep 4, 2014

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

A Phase 1 interventional study of BI 853520 in Neoplasms, sponsored by Boehringer Ingelheim. Completed at 2 sites in 2 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-09-04.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
20 Years and older
Sex
All
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Study 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

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Conditions studied

  • Neoplasms
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In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    BI 853520

    BI 853520 once daily in a dose escalation schedule

    Drug: BI 853520

Interventions

  • DrugBI 853520

    BI 853520 once daily in a dose escalation schedule

06

What researchers measure

Primary outcomes

  1. Determination of the MTD. It will be defined by the occurrence of dose-limiting toxicities (DLT) during the first treatment cycle of each patient

    Time frame: After the first 28 days of treatment

Secondary outcomes

  1. Objective response rate

    Time frame: Every 8 weeks until end of study participation, assessed up to 12 months

  2. Disease control rate

    Time frame: Every 8 weeks until end of study participation, assessed up to 12 months

  3. Duration of disease control

    Time frame: Every 8 weeks until end of study participation, assessed up to 12 months

  4. 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

    Time frame: Every 8 weeks until end of study participation, assessed up to 12 months

07

Study locations

2 sites
  • 1300.15.81001 Boehringer Ingelheim Investigational Site
    Kashiwa-shi, Chiba, Japan
  • 1300.15.88601 Boehringer Ingelheim Investigational Site
    Taipei, Taiwan
08

References and documents

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. PubMed 30725402 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01905111
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 23, 2013
Start date
Jul 2013
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Sep 4, 2014

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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