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

NCT01837667 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-01-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Lixte Biotechnology Holdings, Inc.

    lead INDUSTRY

Principal Investigators

  • Vincent Chung, MD, FACP · City of Hope National Medical Center

  • Aaron Mansfield, MD · Mayo Clinic

  • Fadi Braiteh, MD · Comprehensive Cancer Centers of Nevada

  • Carlos Becerra, MD · Texas Oncology - Baylor Charles A Sammons Cancer Center

  • Donald Richards, MD · Texas Oncology - Tyler

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01837667 on ClinicalTrials.gov