drugset / Trial / NCT01000376
Evaluating 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
Non-randomizedCrossoverOpen-labelTreatment
Summary
The purpose of this study is to investigate whether ketoconazole, taken orally, influences the level of eribulin in the blood when the two drugs are given at the same time. The study will enroll patients with solid tumors whose cancer became worse even after standard treatment, or for whom there is no standard treatment available. The study will also investigate whether eribulin given together with ketoconazole is safe (has few side-effects) and is effective against cancer.
Timeline
- Start
- 2009-02
- Primary completion
- 2009-08
- Completion
- 2009-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eribulin | Small molecule | 0.7 mg/m2 | Intravenous |
| Subject | Eribulin | Small molecule | 1.4 mg/m2 | Intravenous |
| Subject | Ketoconazole | Small molecule | 200 mg | Oral |