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Administration of volasertib in combination with itraconazole (Cycle 1) and afterwards alone (Cycle 2 and beyond).

volasertib

itraconazole

Boehringer Ingelheim

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.

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

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

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

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.

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 0 to infinity (AUC0-∞) of volasertib and its metabolite CD 10899 is reported.

Treated set (TS): All patients who received at least 1 dose of volasertib. This was the full analysis set; it was mainly used for safety analyses.

Patients were administered from Day-3 to Day 15 of Cycle 1 (cycle duration=21 days) once daily two capsules of 100 milligram (mg) of itraconazole (Orungal®) (total daily dose=200 mg) orally. On Day 1 of Cycle 1 patients were also administered intravenously a single dose of 300 mg of solution for infusion of volasertib as a 2 hour (h) infusion. In case of unexpected toxicity the dose of volasertib was to be reduced to 250 mg or 200 mg.

Volasertib + Itraconazole (Cycle 1)

This group included all patients who were administered volasertib from Cycle 2 onwards.

On Day 1 of Cycle 2 (cycle duration=21 days) patients were administered intravenously a single dose of 300 mg of solution for infusion of volasertib as a 2 hour (h) infusion. In case of unexpected toxicity the dose of volasertib was to be reduced to 250 mg or 200 mg.

After Cycle 2 (i.e cycles ≥3): Patients with clinical benefits were administered intravenously on Day 1 of each cycle (cycles ≥3) solution for infusion of volasertib.

Monotherapy Volasertib (Cycle>=2)

Patients were administered from Day-3 to Day 15 of Cycle 1 (cycle duration=21 days) once daily two capsules of 100 milligram (mg) of itraconazole (Orungal®) (total daily dose=200 mg) orally. On Day 1 of Cycle 1 patients were also administered intravenously a single dose of 300 mg of solution for infusion of volasertib as a 2 hour (h) infusion. In case of unexpected toxicity the dose of volasertib was to be reduced to 250 mg or 200 mg.

On Day 1 of Cycle 2 (cycle duration=21 days) patients were administered intravenously a single dose of 300 mg of solution for infusion of volasertib as a 2 hour (h) infusion. In case of unexpected toxicity the dose of volasertib was to be reduced to 250 mg or 200 mg.

After Cycle 2 (i.e cycles ≥3): Patients with clinical benefits were administered intravenously on Day 1 of each cycle (cycles ≥3) solution for infusion of volasertib.

Volasertib + Itraconazole Then Volasertib

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Boehringer Ingelheim, Call Center

Statistical analysis of Volasertib:

AUC0-tz was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR).

Statistical analysis of CD 10899:

AUC0-tz was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR).

CD 10899

Volasertib+ Itraconazole (Cycle 1)

On Day 1 of Cycle 2 (cycle duration=21 days) patients were administered intravenously a single dose of 300 mg of solution for infusion of volasertib as a 2 hour (h) infusion. In case of unexpected toxicity the dose of volasertib was to be reduced to 250 mg or 200 mg.

Volasertib (Cycle 2)

Primary pharmacokinetic set (pPKS) 250 mg: All patients in the treated set (TS) who were treated with volasertib 250 mg in Cycle 1 and Cycle 2 and who provided complete pharmacokinetic (PK) measures without important protocol violations.

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

Statistical analysis of volasertib:

Cmax was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR).

Statistical analysis of CD 10899:

Cmax was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR).

Primary pharmacokinetic set (pPKS) 250 mg: All patients in the treated set (TS) who were treated with volasertib 250 mg in Cycle 1 and Cycle 2 and who provided complete pharmacokinetic set (PK) measures without important protocol violations.

Maximum Measured Concentration of Volasertib and Its Metabolite CD 10899 in Plasma (Cmax)

Statistical analysis of volasertib:

AUC0-∞ was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR).

Statistical analysis of CD 10899:

AUC0-∞ was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR).

Primary pharmacokinetic set (pPKS) 250 mg: All patients in the Treated Set (TS) who were treated with volasertib 250 mg in Cycle 1 and Cycle 2 and who provided complete pharmacokinetic (PK) measures without important protocol violations.

Spots Global Cancer Trial Database for Investigation of Potential Drug-drug Interaction of Volasertib With Itraconazole in Patients With Various Tumours

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