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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00364676
Study type Interventional
Source Spectrum Pharmaceuticals, Inc
Contact
Status Completed
Phase Phase 1
Start date July 2006
Completion date August 2015

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