Cancer Drug metabolism
Conditions
Interventions
At Cycle 1, Day 1 patients will receive a single 2 mg flat dose of 14C-eribulin
(approximately 80 - 90 µCi) as an intravenous infusion over 2 - 5 minutes.
Thereafter patients will be given 1.4 mg/m2
Sponsors
Eisai
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients must have a histologically or cytologically confirmed advanced solid tumor that has progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy). Patients with measurable tumours according to RECIST are desirable but not essential for inclusion. 2. Patients must be aged >= 18 years 3. Patients must have an ECOG Performance Status of 0, 1, or 2 4. Patients must have adequate renal function as evidenced by serum creatinine = 40 mL/minute (min) 5. Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >= 1.5 x 109/L and platelet count >= 100 x 109/L 6. Patients must have adequate hepatic function as evidenced by bilirubin
Exclusion criteria
Exclusion criteria: 1. Patients who have received any of the following treatments within the specified period before treatment start: - chemotherapy, radiation, or biological therapy within three weeks - hormonal therapy within one week - any investigational drug within 4 weeks - Systemic unconventional or alternative therapies including, but not limited to, herbal remedies within 4 weeks 2. Have had radiation therapy encompassing > 30% of marrow 3. Have received prior treatment with mitomycin C or nitrosourea 4. Have had major surgery within 4 weeks before starting study treatment 5. Patients with pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen 6. Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g. radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks 7. Patients with meningeal carcinomatosis 8. Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy, are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) or international normalized ratio (INR) must be closely monitored 9. Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Peri-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential 10. Patients with severe/uncontrolled intercurrent illness/infection 11. Significant cardiovascular impairment (history of congestive heart failure > NYHA grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia) 12. Patients with organ allografts requiring immunosuppression 13. Patients with known positive HIV status 14. Patients with pre-existing neuropathy > Grade 2 15. Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative 16. Patients who participated in a prior eribulin clinical trial, whether or not they received eribulin (E7389). 17. Patients with other significant disease or disorders that, in the Investigator*s opinion, would exclude the patient from the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Safety, tolerability and efficacy of eribulin. | — |
Primary
| Measure | Time frame |
|---|---|
| Excretion balance and metabolic pathway of 14C-eribulin as determined by PK analysis of 14C-eribulin and parent eribulin mesylate in blood, plasma, urine and faeces.. | — |
Countries
Netherlands
Outcome results
None listed