Weekly BI 836880 in Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: BI 836880

• Registration Number: NCT02689505
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a Phase I, multi-centre, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously once a week. The eligible patient population will be patients with advanced solid tumors.

The primary objective of this trial is to determine the maximum tolerated dose (MTD) and recommended Phase II doses for BI 836880 in patients with solid tumors. Preliminary safety data will be evaluated as secondary objectives.

Subsequently, pharmacokinetic profile, pharmacodynamic changes in circulating biomarkers and Dynamic Contrast-Enhanced Magnetic Resonance Imaging ( DCE-MRI), anti-tumor activity and the immunogenicity of BI 836880 will be explored up to a total of 40 patients with advanced solid tumors.

Dose escalation will be guided by a Bayesian logistic regression model with over dose control (EWOC) using at least 2 patients per dose cohorts.

Safety criteria will be followed, including adverse events according to Common Terminology Criteria (CTCAE version 4.03), incidence of dose limiting toxicities, physical examination, vital signs, safety laboratory parameters and Eastern Cooperative Oncology Group (ECOG).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-24
• Study Start: 2016-04-04
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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
BI 836880	BI 836880	-

Primary Outcome Measures

Name	Time	Method
The primary endpoint is to determine the maximum tolerated dose (MTD) based on the number of patients presenting dose limiting toxicity (DLT) using CTCAE V4.03, during the first course and judged to be related to the study medication	up to 6 months

Secondary Outcome Measures

Name	Time	Method
Drug related Adverse Events (AEs) leading to dose reduction or discontinuation during treatment period	up to 6 months

Trial Locations

Locations (2)

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

CTR Georges-François Leclerc; 🇫🇷 Dijon, France