Clinical trialNCT01837667CompletedPhase 1Interventional

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

SponsorLixte Biotechnology Holdings, Inc.Enrollment29CancerNeoplasmsTumors

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Aaron Mansfield, MD
Mayo Clinic
Principal Investigator
clinicaltrials.gov ↗
Carlos Becerra, MD
Texas Oncology - Baylor Charles A Sammons Cancer Center
Principal Investigator
clinicaltrials.gov ↗
Donald Richards, MD
Texas Oncology - Tyler
Principal Investigator
clinicaltrials.gov ↗
Fadi Braiteh, MD
Comprehensive Cancer Centers of Nevada
Principal Investigator
clinicaltrials.gov ↗
Vincent Chung, MD, FACP
City of Hope National Medical Center
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

City of Hope National Medical Center
Duarte, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Docetaxel →LB-100 for Injection

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 28 Feb 2013
Primary completion: 30 Sept 2016
Completion: 30 Sept 2016
Last update posted: 24 Jan 2017
Registered enrollment: 29
Registry id: NCT01837667

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.