Actively Recruiting
A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
Led by Lixte Biotechnology Holdings, Inc. · Updated on 2019-04-08
47
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has signed the Informed Consent Form and can follow study rules
- Creatinine clearance of 60 ml/min or higher
- Total serum bilirubin less than 1.5 times the upper normal limit, or up to 3 times if direct bilirubin is normal in specific conditions
- AST and ALT less than 3 times the upper normal limit
- Age 18 years or older at consent
- Diagnosis of MDS or MDS/myeloproliferative neoplasm by WHO criteria requiring treatment and classified as low or intermediate-1 risk by IPSS
- For non-del(5q) patients: failed prior treatment with at least 2 cycles of azacitidine, decitabine, or lenalidomide due to no response, loss of response, progression, or intolerance
- For del(5q) patients: failed prior treatment with at least 2 cycles of lenalidomide due to no response, loss of response, progression, or intolerance
- ECOG performance status score of 0, 1, or 2
- Women of child-bearing potential and men must agree to use effective contraception before and during the study
You will not qualify if you...
- Known HIV infection
- Symptomatic congestive heart failure
- Myocardial infarction within 6 months before enrollment
- Unstable angina as determined by physician
- Serious uncontrolled cardiac arrhythmia as determined by physician
- QTcF interval of 450 milliseconds or more
- Other cancers with less than 1-year disease-free interval, except certain skin or cervical cancers properly treated
- Use of chemotherapy or experimental agents for MDS within 14 days before study drug treatment
- Concurrent use of erythroid stimulating agents or colony-stimulating factors except short-term use for febrile neutropenia
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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