NCT00756223CompletedPhase 1
An Open-label Phase I Single Dose Escalation Trial of Two Dosing Schedules of BI 831266 Administered Intravenously Over 24 h Continuously in Patients With Advanced Solid Tumours
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 25
- Locations
- 3
- Primary Endpoint
- Maximum tolerated dose
Study Overview
Brief Summary
The main objective of this trial is to provide safety data in terms of drug-related adverse events for the recommendation of the dose for further trials in the development of BI 831266.
Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic and pharmacodynamic profile of BI 831266.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A
Experimental
BI 831266 24h infusion on day 1 and day 15 every 4 weeks
Intervention: Arm A (Drug)
Arm B
Experimental
BI 831266 24h infusion on day 1 every 3 weeks
Intervention: Arm B (Drug)
Outcomes
Primary Outcomes
Maximum tolerated dose
Time Frame: 3-4 weeks
Secondary Outcomes
- Safety parameters (incidence and intensity of AEs graded according to the common terminology criteria for AEs and incidence of DLT)(throughout the study period)
- Pharmacokinetic parameters(throughout the study period)
- Pharmacodynamic analysis(3-4 weeks)
- Efficacy data (progression free survival, objective response rate, response duration)(throughout the study period)
Investigators
Study Sites (3)
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