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Study of LB-100 for Myelodysplastic Syndromes

This study is testing a drug called LB-100 for people with low or intermediate-1 risk Myelodysplastic Syndromes (MDS). MDS is a condition where your bone marrow doesn't make enough healthy blood cells. The study aims to find out if LB-100 is safe and how well it works. LB-100 will be given through an IV (into a vein) over 120 minutes. The study has two parts: first, a small group will receive increasing doses of LB-100 to find a safe dose. Then, a larger group will receive that safe dose to see how effective it is. To join, you must be at least 18 years old and have good organ function. The study will measure how many patients have side effects and how well their MDS responds to the treatment.

Study design
This is an interventional study with an unclear status, planning to enroll 47 participants. It has two phases: Phase 1b to determine safety and Phase 2 to assess effectiveness.
What's involved
You would receive LB-100 intravenously on days 1, 3, and 5 of a 21-day cycle. Your safety will be monitored from the first dose until 30 days after your last dose. Your response to treatment will be checked at the start, and at the end of cycles 3 and 6.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for 30 days after your last dose of the study drug.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03886662

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Lixte Biotechnology Holdings, Inc.
~47 participants
Updated 2019-04-08 on ClinicalTrials.gov
What's tested:LB-100

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over From the first dose of the study drug to 30-days following last dose of the study drug
+1 more outcome measured

Conditions

Myelodysplastic Syndromes

Explore related trials

Myelodysplastic Syndrome

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Rami Komrokji, MD · PRINCIPAL_INVESTIGATOR · H. Lee Moffitt Cancer Center and Research Institute

Who to contact

Lisa Nardelli
[email protected]
813-745-4731
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Creatinine clearance (CrCl) ≥ 60ml/min
Total serum bilirubin \< 1.5 x Upper Limit of Normal (ULN) or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range only in patients with well documented Gilbert's syndrome or hemolysis or who required regular blood transfusions
Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) \< 3.0 x ULN 3. Age ≥18 years at the time of signing the informed consent form. 4. Documented diagnosis of MDS or MDS/myeloproliferative neoplasm (MPN) by World Health Organization (WHO) criteria that require treatment due to cytopenias and meet the International Prognostic Scoring System (IPSS) criteria for low or int-1 risk. 5. For non-del(5q) patients, failed prior treatment with at least 2 cycles started of azacitidine or decitabine or lenalidomide defined as no response to treatment, loss of response at any time point while on treatment or within 6 months of treatment discontinuation, or progressive disease/intolerance to therapy. 6. For del(5q) patients, failed prior treatment with at least 2 cycles started of lenalidomide defined as no response to treatment, loss of response at any time point, or progressive disease/intolerance to therapy. 7. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. 8. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence; tubal ligation, partner's vasectomy) prior to Cycle 1 Day 1 (C1D1) and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion

symptomatic congestive heart failure
myocardial infarction ≤ 6 months prior to enrollment
unstable angina pectoris as designated by the treating physician
serious uncontrolled cardiac arrhythmia as designated by the treating physician
QTcF (Fridericia's correction formula) ≥ 450 msec 3. Concomitant malignancies or previous malignancies with less than a 1-year disease free interval at the time of enrollment. Patients with adequately resected basal or squamous cell carcinoma of the skin, or adequately resected carcinoma in situ (i.e. cervix) may enroll irrespective of the time of diagnosis. 4. Use of chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 14 days of the first day of study drug treatment. 5. No concurrent use of erythroid stimulating agents, Granulocyte-colony stimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GM-CSF) is allowed during study except in cases of febrile neutropenia where G-CSF can be used for short term. Growth factors must be stopped two weeks prior to study. 6. Pregnant women are excluded from this study because LB-100 has not been studied in pregnant subjects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LB-100, breastfeeding should be discontinued if the mother is treated with LB-100.

What this trial measures

  • 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 drugFrom the first dose of the study drug to 30-days following last dose of the study drug

    Number of patients with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0)

  • For Phase 2 - Best overall response rate of patients to the study treatment as a measure of efficacy of LB-100 study drugAt screening and then at the end of Cycle 3 and Cycle 6. (Each cycle is 21 days)

    Best overall response rate of the patients to the study treatment as assessed by International Working Group (IWG) 2006 criteria