Phase I Trial of BI 836845 for Various Solid Cancer

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: BI 836845

• Registration Number: NCT01403974
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This study is a phase I, open-label, dose escalation trial to determine the maximum tolerated dose (MTD) or the relevant biological dose (RBD) in the absence if a MTD of a new drug BI 836845 which blocks the insulin-like 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 Start: 2011-07
• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Primary Completion: 2015-07
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 week, monotherapy

Primary Outcome Measures

Name	Time	Method
Investigator defined dose limiting toxicity (DLT) during first treatment course	3 weeks
Maximum tolerated dose (MTD) or relevant biological dose (RBD) in the absence of MTD	3 weeks

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS) [Days]	every 6 weeks for 18 weeks then every 9 weeks until last administration of BI 836845
Pharmacokinetic (PK) parameters: - Maximum measured plasma concentration (Cmax) - Time from dosing to the maximum plasma concentration (tmax) - Area under the plasma concentration-time curve from 0 hour to the last sampling time point (AUC0-tz)	up to 28 days after end of treatment visit
Disease control (Best overall response of complete response (CR), partial response (PR) or confirmed stable disease (SD) > 24 weeks according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1)	every 6 weeks for 18 weeks then every 9 weeks until last administration of BI 836845 18 weeks
Maximum grade (severity) of Adverse Events according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03	up to 4 months after last administration of BI 836845
Duration of objective response [Days] (Objective response: Best overall response of complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1)	every 6 weeks for 18 weeks then every 9 weeks until last administration of BI 836845 18 weeks
Partial response according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1	every 6 weeks for 18 weeks then every 9 weeks until last administration of BI 836845

Trial Locations

Locations (3)

1280.1.88603 Boehringer Ingelheim Investigational Site; 🇨🇳 Taichung, Taiwan

1280.1.88602 Boehringer Ingelheim Investigational Site; 🇨🇳 Tainan, Taiwan

1280.1.88601 Boehringer Ingelheim Investigational Site; 🇨🇳 Taipei, Taiwan