drug metabolism / cancer
Conditions
Interventions
None listed
Sponsors
Eisai
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Histologically or cytologically confirmed advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy) • Adequate renal function as evidenced by serum creatinine = 40 mL/minute per the Cockcroft and Gault formula • Adequate liver function as evidenced by bilirubin 3 times the ULN (in the absence of liver metastasis) or > 5 times the ULN (in the presence of liver metastasis), and the subject is also known to have bone metastasis, the liver specific ALP must be separated from the total and used to assess the liver function instead of the total ALP. - Age >=18 years. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion criteria
Exclusion criteria: • Subjects with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative or a hypersensitivity to rifampicin • Subjects with prior participation in an eribulin clinical study, even if not previously assigned to eribulin treatment • Subjects with pre-existing neuropathy > Grade 2 • Subjects receiving any medication, dietary supplements or other compounds or substances known to inhibit or induce CYP3A4 at the time the study starts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic - Primary Endpoint: PK parameters AUC0-* and Cmax for eribulin will be estimated in the presence and absence of rifampicin. PK parameters will be calculated by non-compartmental analysis of the plasma concentration-time data. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events both by means of laboratory reserach and by means of physical research and information of the patient. | — |
Countries
Netherlands
Outcome results
None listed