NCT01837667

Phase I Study of LB-100 With Docetaxel in Solid Tumors

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Lixte Biotechnology Holdings, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tumors
• Neoplasms
• Cancer

Interventions

Type	Name	Description
DRUG	LB-100 for Injection	Part 1 and Part 2: LB-100 for Injection infusion on Days 1,2,3 of each 21 day cycle.
DRUG	Docetaxel	Part 2: Docetaxel infusion on Day 2 of each 21 day cycle.

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2013-04-23
• Last updated: 2017-01-24

Locations

5 sites across 1 country: United States