Clinical trial NCT01905111: A Study of BI 853520 in Japanese and Taiwanese Patients With Various Types of Advanced or Metastatic Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-07-23
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Determination of the MTD. It will be defined by the occurrence of dose-limiting toxicities (DLT) during the first treatment cycle of each patient
timeFrame: After the first 28 days of treatment
Secondary outcomes:
measure: Objective response rate
timeFrame: Every 8 weeks until end of study participation, assessed up to 12 months
measure: Disease control rate
timeFrame: Every 8 weeks until end of study participation, assessed up to 12 months
measure: Duration of disease control
timeFrame: Every 8 weeks until end of study participation, assessed up to 12 months
measure: 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
timeFrame: Every 8 weeks until end of study participation, assessed up to 12 months
Other outcomes:
Locations:
city: Kashiwa-shi, Chiba
country: Japan
facility: 1300.15.81001 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1300.15.88601 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.