Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of LAM-003 in Patients With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03426605
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
AI Therapeutics, Inc (formerly known as LAM Therapeutics, Inc.)

Brief Summary:
A Phase 1 Dose-Escalation Study of LAM-003 in Patients with Acute Myeloid Leukemia

Condition or disease Intervention/treatment Phase
Oncology Acute Myeloid Leukemia Drug: Open Label LAM-003 Phase 1

Detailed Description:

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.


Layout table for study information
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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: LAM-003
Open label LAM-003 at three increasing dose levels of 200, 300 and 450 mg.
Drug: Open Label LAM-003
LAM-003




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. Pharmacokinetics (PK) [ Time Frame: During Cycle 1 Visit Days 1, 2, and 8. ]
    Drug concentrations in plasma

  3. 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).

  4. 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).

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women of age ≥18 years.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  3. Presence of measurable AML that has progressed during or relapsed after prior therapy
  4. All acute toxic effects of any prior antitumor therapy resolved to Grade 1.
  5. Adequate hepatic profile.
  6. Adequate renal function.
  7. Adequate coagulation profile.
  8. Negative antiviral serology for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
  9. For female subjects of childbearing potential, a negative serum pregnancy test.
  10. For both male and female subjects, willingness to use adequate contraception.
  11. Willingness and ability of the subject to comply with study activities.
  12. Evidence of a personally signed informed consent document.

Exclusion Criteria:

  1. Leukemic blast cell count >50 × 109/L before the start of study therapy and despite the use hydroxyurea, cytarabine, and/or cyclophosphamide.
  2. Presence of known central nervous system (CNS) leukemia.
  3. Presence of another major cancer.
  4. Ongoing Grade >1 proliferative or nonproliferative retinopathy.
  5. Significant cardiovascular disease or ECG abnormalities.
  6. Significant gastrointestinal disease
  7. Uncontrolled ongoing infection.
  8. Pregnancy or breastfeeding.
  9. Major surgery within 4 weeks before the start of study therapy.
  10. Subject is a candidate for hematopoietic stem cell transplantation (HSCT).
  11. Ongoing severe graft-versus-house disease (GVHD) with Grade ≥2 serum bilirubin, Grade ≥3 skin involvement, or Grade ≥3 diarrhea at the start of study therapy.
  12. Prior solid organ transplantation.
  13. Ongoing immunosuppressive therapy other than corticosteroids.
  14. Use of a strong inhibitor or inducer of cytochrome P450 (CYP) 3A4.
  15. Use of a drug known to prolong the cardiac QT interval.
  16. Concurrent participation in another therapeutic or imaging clinical trial.
  17. Presence of a concomitant medical condition that (in the judgement of the investigator) interferes with the ability of the subject to participate in the study.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Henri Lichenstein, PhD 203-458-7100 hlichens@ai-thera.com

Locations
Layout table for location information
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06511
Contact: Tanya Malak, CCRC    203-785-4699    tanya.malak@yale.edu   
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    ros9120@med.cornell.edu   
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         
Sponsors and Collaborators
AI Therapeutics, Inc (formerly known as LAM Therapeutics, Inc.)
Investigators
Layout table for investigator information
Study Director: Langdon Miller, M.D. LAM Therapeutics

Additional Information:
Layout table for additonal information
Responsible Party: AI Therapeutics, Inc (formerly known as LAM Therapeutics, Inc.)
ClinicalTrials.gov Identifier: NCT03426605     History of Changes
Other Study ID Numbers: LAM-003-HEM-CLN02
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms