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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: BI 853520

• Registration Number: NCT01335269
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial is to determine the safety and tolerability of BI 853520 monotherapy by defining the maximum tolerated dose (MTD) and recommending the dose for further trials in the development of this compound.

Secondary objectives are

* determination of the pharmacokinetic (PK) profile;

* exploratory pharmacodynamic analysis; and

* collection of preliminary data on anti-tumour efficacy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Study Start: 2011-07
• Primary Completion: 2015-09
• Status Verified: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	BI 853520	BI 853520 once daily in a dose escalation schedule

Primary Outcome Measures

Name	Time	Method
Determination of the MTD. It will be defined by the occurrence of dose-limiting toxicities (DLT) during the first treatment cycle of each patient in the dose finding phase	After the first 28 days of treatment

Secondary Outcome Measures

Name	Time	Method
AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)	up to 48 hours
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after the last dose in cycle 1	up to 24 hours
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the last dose in cycle 1	up to 24 hours
Disease control rate (CR or PR or SD per RECIST v1.1) )	up to 39 months
Duration of disease control (measured from drug start date to the date of disease progression for patients who had CR or PR or SD during treatment)	up to 39 months
Objective response rate (CR or PR per RECIST v1.1)	up to 39 months
Tumour shrinkage (in millimetre) defined as change from baseline to the minimum post-baseline sum of diameters of target lesions.	up to 39 months
Pharmacodynamic assessment: phosphorylated and total PTK2 (FAK) modulation in tumour biopsies	baseline, day 22 and day 28
Cmax (maximum measured concentration of the analyte in plasma) after first dose	up to 48 hours

Trial Locations

Locations (5)

1300.2.31002 Boehringer Ingelheim Investigational Site; 🇳🇱 Utrecht, Netherlands

1300.2.1001 Boehringer Ingelheim Investigational Site; 🇨🇦 Toronto, Ontario, Canada

1300.2.31003 Boehringer Ingelheim Investigational Site; 🇳🇱 Amsterdam, Netherlands

1300.2.31001 Boehringer Ingelheim Investigational Site; 🇳🇱 Rotterdam, Netherlands

1300.2.1002 Boehringer Ingelheim Investigational Site; 🇨🇦 Hamilton, Ontario, Canada