BI 811283 in Various Solid Tumours

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: BI 811283

• Registration Number: NCT00701324
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of this trial is to provide safety data in terms of drug-related adverse events (AE) for the recommendation of the dose for further trials in the development of BI 811283.

Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic profile of BI 811283.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-06-18
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-21
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm A	BI 811283	BI 811283, 24h infusion d1 and d15 every 4 weeks
Arm B	BI 811283	BI 811283, 24h infusion d1 every 3 weeks

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose	3-4 weeks

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS), Objective response, Response duration, Pharmacodynamic analysis, Basic pharmacokinetics	throughout the study period
Safety profile: incidence and intensity of AEs graded according to the common terminology criteria for AEs, incidence of DLT	throughout the study period

Trial Locations

Locations (2)

1247.1.49001 Boehringer Ingelheim Investigational Site; 🇩🇪 Freiburg/Breisgau, Germany

1247.1.49002 Boehringer Ingelheim Investigational Site; 🇩🇪 Essen, Germany