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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Eisai Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Eribulin alone	Group 1 Cycle 1 (28 days): Eribulin IV 1.4 mg/m\^2 alone on Day 1, then eribulin IV 0.7 mg/m\^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16. Subsequently, subjects were able to receive eribulin 1.4 mg/m\^2 on Days 1 and 8 every 21 days.
DRUG	Eribulin plus Ketoconazole	Group 2 Cycle 1 (28 days): Eribulin IV 0.7 mg/m\^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m\^2 alone on Day 15. Subsequently, subjects were able to receive eribulin 1.4 mg/m\^2 on Days 1 and 8 every 21 days.

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-08-01
• Completion: 2009-09-01
• First posted: 2009-10-23
• Last updated: 2013-09-23
• Results posted: 2013-09-23

Locations

1 site across 1 country: Netherlands