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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


Phase 1
18 Years
70 Years
Open (Enrolling)
Both
Neoplasms

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Trial Information

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

Inclusion Criteria


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 ┬Ámol/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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

area under the plasma concentration-time curve over the time interval from zero to 336 hours (AUC0-tz)

Outcome Time Frame:

up to 336 hours

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Hungary: National Institute of Pharmacy

Study ID:

1230.24

NCT ID:

NCT01772563

Start Date:

February 2013

Completion Date:

April 2014

Related Keywords:

  • Neoplasms
  • Neoplasms

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