A Study of LAM-003 in Patients With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT03426605|
Recruitment Status : Unknown
Verified December 2018 by AI Therapeutics, Inc..
Recruitment status was: Recruiting
First Posted : February 8, 2018
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Oncology Acute Myeloid Leukemia||Drug: Open Label LAM-003||Phase 1|
This clinical trial is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of LAM-003 across a range of LAM 003 dose levels when administered to subjects with previously treated relapsed or refractory AML.
Subjects will self-administer oral LAM 003 either once or twice per day as long as they are safely benefitting from therapy. Cohorts of 3 to 6 subjects will be sequentially enrolled at progressively higher dose levels of LAM 003 using a standard 3+3 dose-escalation design. Based on the pattern of dose-limiting toxicities observed in the first 4 weeks of therapy, escalation will proceed to define a recommended LAM-003 dosing regimen.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open Label, Dose-Escalation|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Dose-Escalation Study of LAM-003 in Patients With Acute Myeloid Leukemia|
|Actual Study Start Date :||January 16, 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||January 2020|
Open label LAM-003 at three increasing dose levels of 200, 300 and 450 mg.
Drug: Open Label LAM-003
- Maximum tolerated dose (MTD) [ Time Frame: At the end of the 28-day treatment cycle. ]MTD as determined by incidence of dose-limiting toxicities (DLTs)
- Adverse event assessment [ Time Frame: Weekly during the first 4 weeks and then every 4 weeks for up to 48 weeks. ]Incidence of adverse events
- Pharmacokinetics (PK) [ Time Frame: During Cycle 1 Visit Days 1, 2, and 8. ]Drug concentrations in plasma
- Anti-tumor activity [ Time Frame: Every 8 to 12 weeks for up to 48 weeks.. ]Tumor response by acute myeloid leukemia response criteria (Cheson 2003).
- Genetic profile of acute myeloid leukemia blasts [ Time Frame: During Cycle 1 Visits Days 1,2, 8 and 15. ]Changes in genetic profiles of acute myeloid leukemia blasts as measured by next-generation sequencing (NGS).
- Protein profile of acute myeloid leukemia blasts. [ Time Frame: During Cycle 1 Visits Days 1,2, 8 and 15. ]Changes in protein profiles of acute myeloid leukemia blasts as measured by protein immunoblotting.
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): NCT03426605
|Contact: Henri Lichenstein, PhDfirstname.lastname@example.org|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06511|
|Contact: Tanya Malak, CCRC 203-785-4699 email@example.com|
|Principal Investigator: Nikolai Podoltsev|
|United States, Maryland|
|University of Maryland||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Hongxia Li, MBBS, MS 410-328-8708 HongxiaLi@umm.edu|
|Principal Investigator: Maria Baer, MD|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Kelsey O'Day 617-632-5918 Kelsey_O'Day@dfci.harvard.edu|
|Principal Investigator: Marlise Luskin, MD|
|United States, New Jersey|
|Hackensack Meridien Health||Recruiting|
|Hackensack, New Jersey, United States, 07601|
|Contact: James McCloskey, MD 551-996-3925 James.McCloskey@HackensackMeridian.org|
|Principal Investigator: James McCloskey, MD|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10021|
|Contact: Rookmini Singh, MSN 212-746-4882 firstname.lastname@example.org|
|Principal Investigator: Sangmin Lee, MD|
|United States, Virginia|
|Virginia Cancer Specialists||Recruiting|
|Fairfax, Virginia, United States, 22031|
|Contact: Alexander Spira, MD 703-280-5390 Alexander.Spira@USOncology.com|
|Principal Investigator: Alexander Spira, MD|
|Study Director:||Langdon Miller, M.D.||LAM Therapeutics|