NCT01772563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

February 4, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2014

Completed
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2021

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

September 1, 2023

Completed
Last Updated

September 1, 2023

Status Verified

November 1, 2022

Enrollment Period

1.3 years

First QC Date

January 17, 2013

Results QC Date

April 6, 2022

Last Update Submit

November 17, 2022

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    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).

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

    Maximum measured concentration of the analyte (volasertib and its metabolite CD 10899) in plasma (Cmax) is reported.

    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).

Secondary Outcomes (1)

  • 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).

Study Arms (1)

Volasertib + itraconazole then volasertib

EXPERIMENTAL

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

Drug: volasertibDrug: itraconazole

Interventions

volasertibDRUG

Solution for infusion

Volasertib + itraconazole then volasertib
itraconazoleDRUG

capsules

Also known as: Orungal®
Volasertib + itraconazole then volasertib

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Male or female
  • Age =\>18 and =\<70 years
  • Eastern Cooperative Oncology Group (ECOG) performance score =\< 2
  • Recovery from Common Terminology Criteria for Adverse Events (CTCAE) Grade \>= 2 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapy (except alopecia)

You may not qualify if:

  • Serious concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
  • Active infectious disease
  • Viral hepatitis, HIV infection
  • Clinical evidence of active brain metastasis or leptomeningeal disease during the past 6 months
  • Second malignancy currently requiring active therapy (except for hormonal / antihormonal treatment e.g. in prostate or breast cancer)
  • Absolute neutrophil count less than 1,500/mm3
  • Platelet count less than 100,000/mm3
  • Total bilirubin greater than 1.5 mg/dL (\> 26 µmol/L, SI unit equivalent)
  • 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)
  • Serum creatinine greater than 2x upper limit of normal (ULN)
  • 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
  • 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.
  • 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
  • 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).
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

PRA Hungary Ltd., Phase I. Clinical Pharmacology Unit

Budapest, 1077, Hungary

Location

National Institute of Oncology

Budapest, 1122, Hungary

Location

Related Publications (1)

  • Lang I, Liu D, Fritsch H, Taube T, Chizhikov E, Liptai B. Potential Drug-Drug Interactions with Combination Volasertib + Itraconazole: A Phase I, Fixed-sequence Study in Patients with Solid Tumors. Clin Ther. 2020 Nov;42(11):2214-2224. doi: 10.1016/j.clinthera.2020.09.015. Epub 2020 Nov 1.

    PMID: 33139055DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

BI 6727Itraconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 21, 2013

Study Start

February 4, 2013

Primary Completion

May 30, 2014

Study Completion

April 22, 2021

Last Updated

September 1, 2023

Results First Posted

September 1, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

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

Locations

HU(2)