NCT01905111

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2013

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 4, 2014

Status Verified

September 1, 2014

Enrollment Period

1.1 years

First QC Date

July 12, 2013

Last Update Submit

September 3, 2014

Conditions

Neoplasms

Outcome Measures

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

    After the first 28 days of treatment

Secondary Outcomes (4)

  • 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

Study Arms (1)

BI 853520

EXPERIMENTAL

BI 853520 once daily in a dose escalation schedule

Drug: BI 853520

Interventions

BI 853520DRUG

BI 853520 once daily in a dose escalation schedule

BI 853520

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

1300.15.81001 Boehringer Ingelheim Investigational Site

Kashiwa-shi, Chiba, Japan

Location

1300.15.88601 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 30725402DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2013

First Posted

July 23, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 4, 2014

Record last verified: 2014-09

Locations

TW(1)JP(1)