Trial to Determine MTD of BI 836845 Administered Intravenously Once Every Three Weeks in Patients With Advanced Solid Tumours and Later a Weekly Dosing Schedule in Selected Tumour Types

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: BI 836845

• Registration Number: NCT01317420
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This study is a phase I, open-label, dose escalation trial to determine the maximum tolerated dose (MTD) of a new drug BI 836845 which blocks the insulin growth factor (IGF) pathway believed to be involved in cancer growth. BI 836845 will be administered for the very first time into cancer patients.

The study will also look at the overall safety of the drug, and examine the drug levels in the body at specific timepoints during the trial (pharmacokinetic profile); the effect the drug may have on tumours will also be examined (pharmacodynamics).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-16
• Study First Posted: 2011-03-17
• Study Start: 2011-04
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-27
• Last Update Posted: 2016-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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
Monotherapy	BI 836845	BI 836845 dose escalation, infusion, once every three weeks, monotherapy

Primary Outcome Measures

Name	Time	Method
Occurence of drug related dose limiting toxicities for determination of Maximum Tolerated Dose (MTD) (Part I)	12 months
Duration of objective response (CR/PR), defined as time from first objective response to the time to progression or death (Part II).	up to 44 months
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Part II)	up to 44 months
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Part I)	12 months
Intensity of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Part I)	12 months
Response rate (CR/PR/SD) according to RECIST criteria 1.1 (Part II).	up to 44 months
Intensity of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Part II)	up to 44 months

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve over one dosing interval (AUC0-t). (Part I and II)	up to 168 hours
Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC0-inf). (Part I and II)	up to 336 hours
Terminal half-life (t1/2). (Part I and II)	up to 336 hours
Mean residence time after intravenous infusion (MRT). (Part I and II)	up to 336 hours
Total plasma clearance (CL). (Part I and II)	up to 336 hours
Apparent volume of distribution during the terminal phase (Vz). (Part I and II)	up to 336 hours
Volume of distribution after intravenous infusion at steady state (Vss). (Part II)	up to 336 hours
Time from dosing to the maximum plasma concentration (tmax). (Part I and II)	up to 336 hours
Area under the plasma concentration-time curve over the time interval of one week (AUC0-168). (Part I and II)	up to 168 hours
Maximum measured plasma concentration (Cmax). (Part I and II)	up to 336

Trial Locations

Locations (2)

1280.2.4401 Boehringer Ingelheim Investigational Site; 🇬🇧 Sutton, United Kingdom

1280.2.4402 Boehringer Ingelheim Investigational Site; 🇬🇧 Leeds, United Kingdom