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

NCT03426605 | Completed Phase 1 Results FDA Drug

• 1 other identifier: LAM-003-HEM-CLN02
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Oncology; Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  A primary objective was to determine the LAM-003 MTD and/or recommended dosing regimen (RDR) based on the pattern of dose-limiting toxicities (DLTs) in Cycle 1 of therapy. MTD as determined by DLTs.

  At the end of the 28-day observation period for Cycle 1.

Secondary Outcomes (6)

• Adverse Event Assessment

  Weekly during the first 4 weeks and then every 4 weeks for up to 48 weeks.

• Maximum Plasma Concentration (Cmax)

  Cycle 1 Days 1, 2 and 8 (1 cycle = 28 days)

• Time of Maximum Concentration [Tmax]

  Cycle 1 Days 1, 2 and 8 (1 cycle = 28 days)

• Area Under the Curve [AUC]

  Cycle 1 Days 1, 2 and 8 (1 cycle = 28 days)

• Objective Response Rate

  Every 8 to 12 weeks for up to 48 weeks.

Study Arms (1)

LAM-003

EXPERIMENTAL

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

Drug: Open Label LAM-003

Interventions

Open Label LAM-003 DRUG

LAM-003

LAM-003

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OrphAI Therapeutics: lead

Study Sites (6)

Yale University

New Haven, Connecticut, 06511, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Hackensack Meridien Health

Hackensack, New Jersey, 07601, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Related Links

• Trial information can be found on AI Therapeutics website

MeSH Terms

Conditions

Neoplasms; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Esther Nkrumah
• Organization: OrphAI Therapeutics

enkrumah@orphai-therapeutics.com

2675121750

Study Officials

• Langdon Miller, M.D.

  AI Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label, Dose-Escalation

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: February 8, 2018
• Study Start: January 16, 2018
• Primary Completion: February 20, 2020
• Study Completion: October 5, 2020
• Last Updated: May 3, 2024
• Results First Posted: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)