Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068172
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2003-09-09
Brief Title:
Study of PI-88 in Patients With Advanced Melanoma
Sponsor:
Cellxpert Biotechnology Corp
Organization:
Cellxpert Biotechnology Corp
Study Overview
Official Title:
A Phase III Study of PI-88 in Advanced Malignancies Phase I and in Advanced Melanoma Phase II
Status:
COMPLETED
Status Verified Date:
2022-06
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 determine whether PI-88 is safe and effective in the treatment of advanced melanoma
Detailed Description:
PI-88 is an investigational drug that works by a novel mechanism which may reduce the rate of growth of tumors and also the spread of cancer cells around the body It also has an effect upon blood clotting The purpose of this study is to assess if PI-88 has any benefit to patients with advanced melanoma as well as to gain further information on the safety of the drug All patients in the study will receive the study drug at the same dose level The dose of PI-88 that will be given is based on the dose that was found to be the best in the phase I portion of this study The drug will be injected subcutaneously under the skin once daily for 4 days every week Patients will be treated with PI-88 for up to 6 months but if the drug is well tolerated and effective patients may be offered further treatment with the drug
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PR88201A | None | None | None |