Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-01-08 @ 6:19 PM
Study NCT ID:
NCT01957995
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2013-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nanosomal Docetaxel Lipid Suspension in Treating Patients With Advanced Solid Tumors
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-01731 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 022-13 | None | None | View | |
| 0C-13-2 | OTHER | USC Norris Comprehensive Cancer Center | View | |
| P30CA014089 | NIH | None | https://reporter.nih.gov/quic… | View |