A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)

Part of paid clinical trials in Tampa, Florida.

Sponsor
Lixte Biotechnology Holdings, Inc.
Study ID
NCT03886662
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LB-100 — DRUG
    Phase Ib: Two escalating doses of LB-100 in two separate cohorts will be administered intravenously on days 1, 3 and 5 of a 21-day cycle over 120 minutes. Phase 2: Safe dose of LB-100 as determined from phase Ib will be administered intravenously on days 1, 3 and 5 of a 21-day cycle over 120 minutes.

Study Details

The purpose of this study is to test the safety and efficacy (benefits) of an investigational drug LB-100, for treatment of myelodysplastic syndromes. LB-100 has previously been administered to patients with various solid tumors. In this study, LB-100 will be administered as an intravenous infusion over 120 minutes. This study will be conducted in 2 phases. In phase Ib, escalating doses of LB-100 will be administered to patients to study the safety and to determine a safe dose of LB-100. In phase 2, patients will be administered LB-100 at the dose that was found to be safe in phase Ib. The efficacy (benefits) and safety of LB-100 will be determined in this phase of the study.

Key Dates

Start date
Apr 30, 2019
Status verified
Apr 2019
Primary completion
May 31, 2021
Completion
Jul 31, 2021

Study Design

Enrollment
47 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LB-100 for Intravenous administration
    Phase Ib: Escalating doses of LB-100 administered. Phase 2: Safe dose of LB-100 from phase Ib administered.

Primary Outcome Measure

For Phase Ib - Number of patients with adverse events related to the study treatment as a measure of safety and tolerability of LB-100 study drug [ Time Frame: From the first dose of the study drug to 30-days following last dose of the study drug ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612
Lisa Nardelli
[email protected]
813-745-4731
Rami Komrokji, MD (PRINCIPAL_INVESTIGATOR)

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By research site
H. Lee Moffitt Cancer Center & Research Institute· Tampa, FL

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