Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145041
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2005-09-01
Brief Title:
Pharmacokinetic Study of Liposomal Vincristine in Patients With Malignant Melanoma Hepatic Dysfunction
Sponsor:
Acrotech Biopharma Inc
Organization:
Acrotech Biopharma Inc
Study Overview
Official Title:
An Evaluation of the Pharmacokinetic Profile of VSLI Vincristine Sulfate Liposome Injection 016 mgmL in Patients With Malignant Melanoma and Hepatic Dysfunction Secondary to Metastases
Status:
COMPLETED
Status Verified Date:
2019-12
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:
The purpose of this study is to see how vincristine when placed in an oil droplet called a liposome VSLI is absorbed distributed moved around and excreted from the the body pharmacokinetics This study will also assess the safety of VSLI and to see if VSLI will slow the growth or shrink tumors in patients with metastatic melanoma that has resulted in liver impairment and who have relapsed after previous therapies
Detailed Description:
OBJECTIVES
Primary To assess the pharmacokinetics of VSLI administered intravenously to patients with malignant melanoma and hepatic dysfunction secondary to metastases
Secondary To assess the safety and antitumor activity of VSLI in this population
Primary To assess the pharmacokinetics of VSLI administered intravenously to patients with malignant melanoma and hepatic dysfunction secondary to metastases
Secondary To assess the safety and antitumor activity of VSLI in this population
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