Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00364676
Status:
COMPLETED
Last Update Posted:
2015-09-22
First Post:
2006-08-14
Brief Title:
Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors Non-Hodgkins Lymphoma or Hodgkins Disease
Sponsor:
Spectrum Pharmaceuticals Inc
Organization:
Spectrum Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Study of Vinorelbine Liposomes Injection VLI for Treatment in Patients With Advanced Solid Tumors Non-Hodgkins Lymphoma or Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2015-09
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 Phase 1 study will determine the safety tolerability and pharmacokinetics of vinorelbine liposomes injection VLI in patients with advanced solid tumors non-Hodgkins lymphoma or Hodgkins 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
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 Oversight
Has Oversight DMC:
None
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?:
None