A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
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|ClinicalTrials.gov Identifier: NCT03886662|
Recruitment Status : Unknown
Verified April 2019 by Lixte Biotechnology Holdings, Inc..
Recruitment status was: Recruiting
First Posted : March 22, 2019
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes||Drug: LB-100||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2 Study Evaluating the Safety and Efficacy of Intravenous LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Had Disease Progression or Are Intolerant to Prior Therapy|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: LB-100 for Intravenous administration
Phase Ib: Escalating doses of LB-100 administered. Phase 2: Safe dose of LB-100 from phase Ib administered.
Phase Ib: Two escalating doses of LB-100 in two separate cohorts will be administered intravenously on days 1, 3 and 5 of a 21-day cycle over 120 minutes.
Phase 2: Safe dose of LB-100 as determined from phase Ib will be administered intravenously on days 1, 3 and 5 of a 21-day cycle over 120 minutes.
- 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 [ Time Frame: From 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 drug [ Time Frame: At 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886662
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Lisa Nardelli 813-745-4731 Lisa.Nardelli@moffitt.org|
|Principal Investigator: Rami Komrokji, MD|
|Principal Investigator:||Rami Komrokji, MD||H. Lee Moffitt Cancer Center and Research Institute|