Status:
COMPLETED
A Study of LAM-003 in Patients With Acute Myeloid Leukemia
Lead Sponsor:
OrphAI Therapeutics
Conditions:
Oncology
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Men and women of age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Presence of measurable AML that has progressed during or relapsed after prior therapy
- All acute toxic effects of any prior antitumor therapy resolved to Grade 1.
- Adequate hepatic profile.
- Adequate renal function.
- Adequate coagulation profile.
- Negative antiviral serology for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
- For female subjects of childbearing potential, a negative serum pregnancy test.
- For both male and female subjects, willingness to use adequate contraception.
- Willingness and ability of the subject to comply with study activities.
- Evidence of a personally signed informed consent document.
Exclusion
- Leukemic blast cell count \>50 × 10\^9/L before the start of study therapy and despite the use hydroxyurea, cytarabine, and/or cyclophosphamide.
- Presence of known central nervous system (CNS) leukemia.
- Presence of another major cancer.
- Ongoing Grade \>1 proliferative or nonproliferative retinopathy.
- Significant cardiovascular disease or ECG abnormalities.
- Significant gastrointestinal disease
- Uncontrolled ongoing infection.
- Pregnancy or breastfeeding.
- Major surgery within 4 weeks before the start of study therapy.
- Subject was a candidate for hematopoietic stem cell transplantation (HSCT).
- 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.
- Prior solid organ transplantation.
- Ongoing immunosuppressive therapy other than corticosteroids.
- Use of a strong inhibitor or inducer of cytochrome P450 (CYP) 3A4.
- Use of a drug known to prolong the cardiac QT interval.
- Concurrent participation in another therapeutic or imaging clinical trial.
- 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.
Key Trial Info
Start Date :
January 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03426605
Start Date
January 16 2018
End Date
October 5 2020
Last Update
May 3 2024
Active Locations (6)
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1
Yale University
New Haven, Connecticut, United States, 06511
2
University of Maryland
Baltimore, Maryland, United States, 21201
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
Hackensack Meridien Health
Hackensack, New Jersey, United States, 07601