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NCT03886662 · ClinicalTrials.gov registry record · Phase 1
A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
A Phase 1 study of Myelodysplastic Syndromes, sponsored by Lixte Biotechnology Holdings.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 1
- Study location
NCT03886662 is a Phase 1 study of Myelodysplastic Syndromes that is actively recruiting participants, run by Lixte Biotechnology Holdings. The registered enrollment target is 47 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03886662, a Phase 1 study of Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Lixte Biotechnology Holdings.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG LB-100
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2019-04 |
| Est. Completion | 2021-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03886662
The ClinicalTrials.gov registry entry for NCT03886662 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (84% lower). The listed sponsor is Lixte Biotechnology Holdings, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention - of which LB-100 is the first listed.
NCT03886662 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT03886662 about?
NCT03886662 is a clinical study titled "A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)". 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 ...
What is the current status of trial NCT03886662?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2019-04. Estimated completion is 2021-07.
What conditions does trial NCT03886662 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes.
What interventions are being tested in trial NCT03886662?
The interventions under investigation include: LB-100 (DRUG).
Who is sponsoring clinical trial NCT03886662?
This trial is sponsored by Lixte Biotechnology Holdings, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03886662 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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