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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: 750 milligram Xentuzumab; Drug: 1000 milligram Xentuzumab; Drug: 1400 milligram Xentuzumab

• 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
• Study Completion: 2023-07-14
• Results First Submitted: 2025-05-14
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Results First Posted: 2025-06-19
• Last Update Posted: 2025-06-19

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
750 milligram Xentuzumab	750 milligram Xentuzumab	750 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.
1000 milligram Xentuzumab	1000 milligram Xentuzumab	1000 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.
1400 milligram Xentuzumab	1400 milligram Xentuzumab	1400 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of Xentuzumab in Japanese Patients With Advanced Solid Tumours, as Identified by the Number of Patients With Dose-limiting Toxicities (DLTs)	During the first cycle of treatment, up to 21 days of treatment.	MTD of xentuzumab in Japanese patients with advanced solid tumours, as identified by the number of patients with DLTs. The MTD of xentuzumab was defined as the highest dose tested with DLT occurring in not more than 1 out of 6 evaluable patients.; DLTs were defined as: Haematological toxicities: Common Terminology Criteria for Adverse Events (CTCAE) grade (g) 4 neutropenia ≥7 days (d), select cases of Febrile neutropenia, Infections or CTCAE g4 thrombocytopenia or CTCAE g3 thrombocytopenia.; Non-haematological toxicities: CTCAE grade 3 or 4 non-haematologic toxicity, with exceptions CTCAE grade≥2 infusion reaction or nausea and/or vomiting with exceptions CTCAE grade ≥3 skin toxicity, hyperglycaemia, any electrolyte adverse events (AE), fatigue or asthenia with exceptions No recovery from a non-DLT CTCAE g≥3 toxicity to g≤1 within 14 d of administered dose Other drug-related AEs (CTCAE g2), might qualify as a DLT, which will be determined on a case by case bases.

Trial Locations

Locations (1)

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

National Cancer Center Hospital East

🇯🇵Chiba, Kashiwa, Japan