NCT00364676

Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease

A Phase 1 Study of Vinorelbine Liposomes Injection (VLI) for Treatment in Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1 study will determine the safety, tolerability, and pharmacokinetics of vinorelbine liposomes injection (VLI) in patients with advanced solid tumors, non-Hodgkin's lymphoma, or Hodgkin's disease.

Detailed description

The objectives of this study are: * To assess the safety and tolerability of treatment with VLI. * To determine the maximum tolerated dose (MTD) of VLI. * To characterize the pharmacokinetic (PK) profile of VLI. * To explore preliminary tumor response of VLI.

Conditions

• Tumors
• Hodgkins Disease
• Non-Hodgkins Lymphoma

Interventions

Type	Name	Description
DRUG	VLI	Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
DRUG	VLI	Patients are dosed on Day 1 of a 21-day cycle.

Timeline

• Start date: 2006-07-01
• Primary completion: 2015-06-01
• Completion: 2015-08-01
• First posted: 2006-08-16
• Last updated: 2015-09-22

Locations

3 sites across 2 countries: United States, Canada