Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-30 @ 5:47 AM
Study NCT ID:
NCT01837667
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2013-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of LB-100 With Docetaxel in Solid Tumors
Sponsor:
Lixte Biotechnology Holdings, Inc.
Organization:
Study Overview
Official Title:
A Phase I Study of Intravenous LB-100 for Injection as a Single Agent and in Combination With Docetaxel in the Treatment of Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2016-09
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:
The purpose of this study is to test the safety of an investigational drug called LB-100 for Injection for treatment of solid tumors, when given with or without docetaxel. LB-100 is a small molecule that in laboratory and animal studies has shown activity when used by itself or together with drugs approved to treat some types of cancer (chemotherapeutic agents). Docetaxel is a drug that has been approved for the treatment of some types of cancer; one of the trade names for docetaxel is Taxotere®. The study is in 2 parts. Part 1: Patients will receive injections of LB-100. Part 2: Patients will receive injections of LB-100 and docetaxel. This is the first study where LB-100 for Injection will be used in humans.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: