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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
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.
Details
| Lead sponsor | Lixte Biotechnology Holdings, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 29 |
| Start date | 2013-02 |
| Completion | 2016-09 |
Conditions
- Tumors
- Neoplasms
- Cancer
Interventions
- LB-100 for Injection
- Docetaxel
Primary outcomes
- Number of patients with adverse events as a measure of safety and tolerability of LB-100 for Injection treatment plus docetaxel. — Starting from date of first dose up to 30 days after last dose.
Countries
United States