Investigation of Potential Drug-drug Interaction of Volasertib With Itraconazole in Patients With Various Tumours

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: volasertib; Drug: itraconazole

• Registration Number: NCT01772563
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-17
• Study First Posted: 2013-01-21
• Study Start: 2013-02-04
• Primary Completion: 2014-05-30
• Study Completion: 2021-04-22
• Results First Submitted: 2022-04-06
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-17
• Last Update Submitted: 2022-11-17
• Results First Posted: 2023-09-01
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volasertib + itraconazole then volasertib	itraconazole	Administration of volasertib in combination with itraconazole (Cycle 1) and afterwards alone (Cycle 2 and beyond).
Volasertib + itraconazole then volasertib	volasertib	Administration of volasertib in combination with itraconazole (Cycle 1) and afterwards alone (Cycle 2 and beyond).

Primary Outcome Measures

Name	Time	Method
Maximum Measured Concentration of Volasertib and Its Metabolite CD 10899 in Plasma (Cmax)	30 minutes before volasertib administration and 1 hour (h), 1.75h, 4h, 6h, 8h, 12h, 24, 36h, 48h, 72h, 168h, 336h, 504 h after volasertib administration on Day 1 of Cycle 1 (Volasertib+ Itraconazole) and of Cycle 2 (Volasertib).	Maximum measured concentration of the analyte (volasertib and its metabolite CD 10899) in plasma (Cmax) is reported.
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Last Quantifiable Drug Plasma Concentration After Dose Administration (AUC0-tz) of Volasertib and Its Metabolite CD 10899	30 minutes before volasertib administration and 1 hour (h), 1.75h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 168h, 336h, 504 h after volasertib administration on Day 1 of Cycle 1 (Volasertib+ Itraconazole) and of Cycle 2 (Volasertib).	Area under the plasma concentration-time curve over the time interval from zero to the last quantifiable drug plasma concentration after dose administration (AUC0-tz) of volasertib and its metabolite CD 10899 is reported.

Secondary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve Over the Time Interval From 0 to Infinity (AUC0-∞) of Volasertib and Its Metabolite CD 10899	30 minutes before volasertib administration and 1 hour (h), 1.75h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 168h, 336h, 504 h after volasertib administration on Day 1 of Cycle 1 (Volasertib+ Itraconazole) and of Cycle 2 (Volasertib).	Area under the plasma concentration-time curve over the time interval from 0 to infinity (AUC0-∞) of volasertib and its metabolite CD 10899 is reported.

Trial Locations

Locations (2)

National Institute of Oncology; 🇭🇺 Budapest, Hungary

PRA Hungary Ltd., Phase I. Clinical Pharmacology Unit; 🇭🇺 Budapest, Hungary