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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: Recruiting Phase 1 study of Myelodysplastic Syndromes, sponsored by Lixte Biotechnology Holdings.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of patients with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0)
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 |
What NCT03886662 shows while recruiting
NCT03886662 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndromes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03886662's enrollment target sits among peer trials
47 93rd of 173 higher than 81 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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