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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-04

Study Completion Date

2021-04-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Volasertib + itraconazole then volasertib

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

Group Type EXPERIMENTAL

volasertib

Intervention Type DRUG

Solution for infusion

itraconazole

Intervention Type DRUG

capsules

Interventions

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volasertib

Solution for infusion

Intervention Type DRUG

itraconazole

capsules

Intervention Type DRUG

Other Intervention Names

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Orungal®

Eligibility Criteria

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Inclusion Criteria

1. Patients with histologically or cytologically confirmed diagnosis of advanced, non resectable and / or metastatic solid tumour, for whom conventional treatment has failed, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment based on the investigator's assessment
2. Male or female
3. Age =\>18 and =\<70 years
4. Eastern Cooperative Oncology Group (ECOG) performance score =\< 2
5. Recovery from Common Terminology Criteria for Adverse Events (CTCAE) Grade \>= 2 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapy (except alopecia)

Exclusion Criteria

1. Serious concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
2. Active infectious disease
3. Viral hepatitis, HIV infection
4. Clinical evidence of active brain metastasis or leptomeningeal disease during the past 6 months
5. Second malignancy currently requiring active therapy (except for hormonal / antihormonal treatment e.g. in prostate or breast cancer)
6. Absolute neutrophil count less than 1,500/mm3
7. Platelet count less than 100,000/mm3
8. Total bilirubin greater than 1.5 mg/dL (\> 26 µmol/L, SI unit equivalent)
9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
10. Serum creatinine greater than 2x upper limit of normal (ULN)
11. QTcF prolongation \> 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).The QTcF will be calculated as the mean of the 3 ECGs taken at screening
12. Female patients with childbearing potential and unwilling to use a medically acceptable method of contraception during the trial and for at least six months after end of active therapy. Woman of childbearing potential (premenopausal female) is defined as the female who is not surgically sterilised by hysterectomy or bilateral tubal ligation or post-menopausal for at least 12 months.
13. Treatment with other investigational drugs or participation in another clinical trial within the past four weeks prior to start of therapy or concomitantly with this trial
14. Chemo-, radio- immuno-, or molecular-targeted cancer-therapy within the past four weeks prior to start of therapy or concomitantly with this trial. This restriction does not apply to steroids, bisphosphonates hormonal / antihormonal treatment (e.g. in prostate or breast cancer).
15. Alcohol abuse more than an average 3 units of alcoholic beverages per day or more than 21 units per week (1 unit equals 0.5 pint \[285 mL\] of beer or lager, 1 glass \[125 mL\] of wine, 25 mL shot of 40% spirit) or drug abuse
16. Life expectancy less than 12 weeks
17. Potent CYP 3A4 and P-glycoprotein inhibitors other than the study drug or inducers between one week prior to first drug administration or expected treatment with a respective drug until the last PK sample is collected

1. Strong CYP 3A4 inhibitors: atazanavir, clarithromycin, indinavir, itraconazole (other then study drug), ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin
2. CYP 3A4 inducers: carbamazepine, rifampicin
3. P-gp inhibitors: cyclosporine, erythromycin, itraconazole (other then study drug), ketoconazole, quinidine, phenobarbital salt with quinidine, ritonavir, valspodar, verapamil
4. P-gp inducers: hypericum perforatum, rifampicin

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No