NCT01957995

Nanosomal Docetaxel Lipid Suspension in Treating Patients With Advanced Solid Tumors

An Open Label, Randomized Study to Evaluate Safety and Pharmacokinetics of Intravenous Infusion of Nanosomal Docetaxel Lipid Suspension for Injection in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase I trial studies the side effects and best dose of nanosomal docetaxel lipid suspension in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as nanosomal docetaxel lipid suspension, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description

PRIMARY OBJECTIVES: I. To assess the pharmacokinetics profile of nanosomal docetaxel lipid suspension (NDLS) in patients with advanced solid tumors. SECONDARY OBJECTIVES: I. To assess the safety and toxicity of NDLS in patients with advanced solid tumors. OUTLINE: Patients are randomized to 1 of 4 treatment arms. ARM I: Patients receive lowest dose nanosomal docetaxel lipid suspension intravenously (IV) over 1 hour. ARM II: Patients receive low dose nanosomal docetaxel lipid suspension IV over 1 hour. ARM III: Patients receive high dose nanosomal docetaxel lipid suspension IV over 1 hour. ARM IV: Patients receive highest dose nanosomal docetaxel lipid suspension IV over 1 hour. In all arms, treatment may repeat every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	nanosomal docetaxel lipid suspension	Given IV
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2013-11-08
• Primary completion: 2014-05-29
• Completion: 2016-07-14
• First posted: 2013-10-08
• Last updated: 2017-04-11

Locations

1 site across 1 country: United States