Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: Xentuzumab, low dose, every week (qw); Drug: Xentuzumab, middle dose, qw; Drug: Xentuzumab, high dose, qw

• Registration Number: NCT02145741
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This open-label dose escalation phase I trial, 1280.15, is with the first administration of BI 836845 in Japanese patients with various types of advanced solid tumours. The rationale behind this study is to identify the maximum tolerated dose (MTD) of BI 836845 in Japanese patients with advanced solid tumours as weekly intravenous administration.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-23
• Study Start: 2014-06-11
• Primary Completion: 2015-07-01
• Status Verified: 2023-07
• Study Completion: 2023-07-14
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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
Xentuzumab	Xentuzumab, low dose, every week (qw)	Patients to receive low, middle, and high doses of Xentuzumab intravenously (IV)
Xentuzumab	Xentuzumab, middle dose, qw	Patients to receive low, middle, and high doses of Xentuzumab intravenously (IV)
Xentuzumab	Xentuzumab, high dose, qw	Patients to receive low, middle, and high doses of Xentuzumab intravenously (IV)

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of BI 836845 in Japanese patients with advanced solid tumours (as identified by the number of patients with dose-limiting toxicities(DLTs))	21 days

Trial Locations

Locations (1)

National Cancer Center Hospital East; 🇯🇵 Chiba, Kashiwa, Japan