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.)

Tracking Information
First Submitted Date  ICMJE January 5, 2018
First Posted Date  ICMJE February 8, 2018
Last Update Posted Date December 11, 2018
Actual Study Start Date  ICMJE January 16, 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03426605 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LAM-003 in Patients With Acute Myeloid Leukemia
Official Title  ICMJE A Phase 1 Dose-Escalation Study of LAM-003 in Patients With Acute Myeloid Leukemia
Brief Summary A Phase 1 Dose-Escalation Study of LAM-003 in Patients with Acute Myeloid Leukemia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Open Label, Dose-Escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Oncology
  • Acute Myeloid Leukemia
Intervention  ICMJE Drug: Open Label LAM-003
LAM-003
Study Arms  ICMJE Experimental: LAM-003
Open label LAM-003 at three increasing dose levels of 200, 300 and 450 mg.
Intervention: Drug: Open Label LAM-003
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Henri Lichenstein, PhD 203-458-7100 hlichens@ai-thera.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03426605
Other Study ID Numbers  ICMJE LAM-003-HEM-CLN02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AI Therapeutics, Inc (formerly known as LAM Therapeutics, Inc.)
Study Sponsor  ICMJE AI Therapeutics, Inc (formerly known as LAM Therapeutics, Inc.)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Langdon Miller, M.D. LAM Therapeutics
PRS Account AI Therapeutics, Inc (formerly known as LAM Therapeutics, Inc.)
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP