Dose Finding Study of BI 836880 in Patients With Solid Tumors
Phase 1
Completed
- Conditions
- Neoplasms
- Interventions
- Drug: BI 836880
- Registration Number
- NCT02674152
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is a Phase I, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously. The eligible patient population will be patients with advanced solid tumours. At any time during the trial, it will not be permitted to escalate to a dose which does not fulfil the escalation with overdose control (EWOC) criterion
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
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 to assess the maximum tolerated dose (MTD) is based on the number of patients presenting dose-limiting toxicities (DLTs) using CTCAE v4.03, judged to be related to the study medication evaluated over the first cycle of treatment. 3 weeks
- Secondary Outcome Measures
Name Time Method Number of patients experiencing drug related AE leading to dose reduction or discontinuation from start of treatment until end of treatment up to 24 weeks Disposition kinetic measures (t1/2 ) after the first dose 36 weeks Exposure measures (AUC0-tz) after the first dose 36 weeks
Trial Locations
- Locations (3)
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Universitätsklinikum Augsburg
🇩🇪Augsburg, Germany
INS Curie
🇫🇷Paris, France