An Open-Label, Phase I Study to Evaluate the Pharmacokinetics and Tolerance of Co-administration of Oral Multiple Dose of Ketoconazole and an IV (bolus) Infusion of Eribulin in Patients with Advanced Solid Tumors - NVT

Eisai0 sites12 target enrollmentTBD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Eisai
Enrollment: 12
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Investigators

Sponsor

Eisai

Eligibility Criteria

Inclusion Criteria

•1\. Patients must have a histologically or cytologically confirmed solid tumour in an advanced stage that showed progression when standard therapy was followed or for which there is no standard therapy (including surgery or radiotherapy).
•2\. Resolution of all chemotherapy\- or radiotherapy\-related toxicities with a severity of class 1 or lower, except for stable sensory neuropathy \<\= class 2 and alopecia.
•3\. Patients must be \>\= 18 years old.
•4\. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2\.
•5\. A life expectancy of \>\= 3 months.
•6\. Patients must have adequate renal function that must be apparent from serum creatinine \<\= 2\.0 mg/dl (\<\= 176 µmol/l) or calculated creatinine clearance \>\= 40 ml/minute (min) according to the Cockcroft and Gault formula.
•7\. Patients must have adequate hepatic function that must be apparent from bilirubin \<\= 1\.5 times the upper limit of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<\= 3 times the ULN, (in the case of liver metastases \<\= 5 times the ULN or in the case of bone metastases, the liver\-specific alkaline phosphatase \<\= 3 times the ULN).
•8\. Patients must have adequate bone marrow function as demonstrated by means of absolute neutrophil count (ANC) \>\= 1\.5 x 109/l, haemoglobin \>\= 10\.0 g/dl or \>\= 6\.2 mmol/l (a haemoglobin \< 10\.0 g/dl or \< 6,2 mmol/l is acceptable if it is corrected by growth factor or transfusion) and blood platelets \>\= 100 x 109/l.
•9\. Patients must be willing and able to keep to the study protocol for the duration of the study.
•10\. Prior to any study\-specific screening procedures whatsoever, patients must give written consent after receipt of information, on condition that the patient may withdraw his consent at any time without this having any consequences.

Exclusion Criteria

•1\. Patients who have received any of the following treatments within the specified period before the start of treatment with eribulin:
•a) Chemotherapy, radiotherapy or biological therapy within 2 weeks.
•b) Hormonal treatment within 1 week.
•c) Any study drug whatsoever within 4 weeks.
•2\. Patients receiving anticoagulant therapy with warfarin or related compounds, other than for good flow in the infusion line and who cannot be switched to heparin\-based treatment cannot be considered. If a patient has to remain on a minidose of warfarin, the prothrombin time (PT) or international normalised ratio (INR) must be closely monitored.
•3\. Patients who at the time of the start of the study are receiving any medication, food supplements or other compounds or substances known to induce or inhibit the effect of CYP3A4, with the exception of ketoconazole.
•4\. Patients for whom the use of ketoconazole is contraindicated.
•5\. Patients receiving medications that might influence the metabolism of ketoconazole.
•6\. Pregnant or breast\-feeding women; women of child\-bearing age with a positive pregnancy test during screening or without a pregnancy test; women of child\-bearing age unless (1\) they have been surgically sterilised or (2\) in the opinion of the investigator are taking adequate contraceptive measures. To be able to say of women that they are unable to have children, women who are perimenopausal must have been amenorrhoeic for at least 12 months.
•7\. Fertile men who are not willing to use contraception or fertile men with a female partner who is not willing to use contraception.