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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-16

Study Completion Date

2020-10-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

NCT01433965

Acute Myeloid Leukemia Myelodysplastic Syndrome

COMPLETED PHASE1

Lenalidomide In Patients With Acute Myeloid Leukemia

NCT00839059

Acute Myeloid Leukemia

TERMINATED PHASE1

Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia

NCT03441048

Acute Myeloid Leukemia

COMPLETED PHASE1

Lenalidomide and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT01246622

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) +4 more

COMPLETED PHASE1

Revlimid in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome

NCT00360672

Acute Myelogenous Leukemia Myelodysplastic Syndrome

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 cute Myeloid Leukemia (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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oncology Acute Myeloid Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Open Label, Dose-Escalation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LAM-003

Open label LAM-003 at three sequentially increasing starting dose levels of 200, 300 and 450 mg.

Group Type EXPERIMENTAL

Open Label LAM-003

Intervention Type DRUG

LAM-003

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Open Label LAM-003

LAM-003

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 × 10\^9/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 was 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No