At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
volasertib +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 Fixed Sequence Trial to Investigate the Potential Drug-drug Interaction of Intravenous Volasertib Co-administered With a P-gp and CYP3A4 Inhibitor (Itraconazole p.o.) in Patients With Various Solid Tumours
In Brief
A Phase 1 clinical trial evaluating volasertib and itraconazole for Neoplasms. Completed, enrolled 28 participants across 2 sites.
Detailed Summary
The primary objective of the present study is to investigate the influence of co-administration of itraconazole and volasertib on the pharmacokinetic profile of volasertib without co-administration of itraconazole. Secondary objectives are to investigate safety, tolerability and preliminary therapeutic effects following intravenous administration of volasertib.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesHungary
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartFeb 2013
Primary CompletionMay 2014
Study CompletionApr 2021
TodayJul 2026
First PostedJan 21, 2013
Enrollment StartFeb 4, 2013
Primary CompletionMay 30, 2014
Study CompletionApr 22, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.4 years ago
Interventions
volasertibdrug
Solution for infusion
itraconazoledrug
capsules