At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 96 enrolled
Drug / intervention
BI 853520drug
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 I Dose Finding Study of BI 853520 Administered Orally in a Continuous Dosing Schedule in Patients With Various Advanced or Metastatic Non-hematologic Malignancies
In Brief
A Phase 1 clinical trial evaluating BI 853520 for Neoplasms. Completed, enrolled 96 participants across 5 sites in 2 countries.
Detailed Summary
The primary objective of this trial is to determine the safety and tolerability of BI 853520 monotherapy by defining the maximum tolerated dose (MTD) and recommending the dose for further trials in the development of this compound. Secondary objectives are * determination of the pharmacokinetic (PK) profile; * exploratory pharmacodynamic analysis; and * collection of preliminary data on anti-tumour efficacy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesCanada, Netherlands
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2011
Enrollment StartJul 2011
Primary CompletionSep 2015
Study CompletionDec 2015
TodayJul 2026
First PostedApr 14, 2011
Enrollment StartJul 1, 2011
Primary CompletionSep 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.2 years ago
Interventions
BI 853520drug
BI 853520 once daily in a dose escalation schedule