At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 69 enrolled
Drug / intervention
day 1 to day 5 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Phase Ia/Ib Study of Two Dosing Schedules of BI 847325, Orally Administered Once a Day in Patients With Advanced Solid Tumours, With Repeated Cyclic Administration in Patients With Clinical Benefit
In Brief
A Phase 1 clinical trial evaluating day 1 to day 5 and day 1 to day 14 for Neoplasms. Completed, enrolled 69 participants across 2 sites.
Detailed Summary
The aim of the Phase Ia (dose escalation) part of this trial is to assess the maximum tolerated dose (MTD) of BI 847325 administered at escalating doses in 2 treatment arms. In the Phase Ib expansion part of the trial, the aim is to further evaluate the safety profile of BI 847325 at the recommended dose and schedule and to assess target modulation and the potential antitumour efficacy in patients with selected tumour types.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesBelgium
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2011
Enrollment StartApr 2011
Primary CompletionJun 2013
Study CompletionOct 2013
TodayJul 2026
First PostedMar 29, 2011
Enrollment StartApr 15, 2011
Primary CompletionJun 6, 2013
Study CompletionOct 10, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.3 years ago
Interventions
day 1 to day 5drug
low to high dose
day 1 to day 14drug
low to high dose