Phase I Study of BI 831266 in Patients With Advanced Solid Tumours
Phase 1
Completed
- Conditions
- Neoplasms
- Interventions
- Drug: Arm ADrug: Arm B
- Registration Number
- NCT00756223
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Arm A BI 831266 24h infusion on day 1 and day 15 every 4 weeks Arm B Arm B BI 831266 24h infusion on day 1 every 3 weeks
- Primary Outcome Measures
Name Time Method Maximum tolerated dose 3-4 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (3)
1257.1.4303 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
1257.1.4301 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1257.1.4302 Boehringer Ingelheim Investigational Site
🇦🇹Salzburg, Austria