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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
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 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 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.
National Cancer Center Hospital East
Chiba, Kashiwa, Japan
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)
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.
Time frame: During the first cycle of treatment, up to 21 days of treatment.
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