drugset / Trial / NCT01945710
An Open-label, Multicenter, Multiple Dose, Phase 1 Study to Establish the Maximum Tolerated Dose of E7389 Liposomal Formulation in Patients With Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Study E7389-E044-112 is a Phase 1 study designed to assess the safety, tolerability and preliminary efficacy of eribulin-liposomal formulation (E7389-LF) in patients with solid tumors. This dose-escalation study will determine the maximum tolerated dose, dosing schedules tested, the dose schedule regimen with a more favorable tolerability profile, and a preliminary indication of efficacy.
Timeline
- Start
- 2012-12-11
- Primary completion
- 2015-10
- Completion
- 2016-05-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eribulin | Small molecule | 1 mg/m2 | Intravenous |
| Subject | Eribulin | Small molecule | 3.5 mg/m2 | Intravenous |