A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
Recruiting
Phase 1
Phase 2
Interventional Study
Myelodysplastic Syndromes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 47 (estimated)
- Sponsor
- Lixte Biotechnology Holdings, Inc. · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patient has signed the Informed Consent Form (ICF) and is able to comply with protocol requirements.
2. Patient has adequate organ function as defined by the following laboratory values:
* Creatinine clearance (CrCl) ≥ 60ml/min
* Total serum bilirubin \< 1.5 x Upper Li…
Contacts
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