Clinical Trials /

A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies

NCT02520427

Description:

The purpose of this First-in-Human Phase 1 study is to determine if AMG 330 given as a continuous IV infusion is safe and tolerable in adult subjects that have myeloid malignancies, and to determine the maximum tolerated dose and/or a biologically active dose. The study will be conducted in multiple sites and test increasing doses of AMG 330. The safety of subjects will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests.

Related Conditions:
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02520427

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies
  • Official Title: A Phase 1 First-in-human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 330 Administered as Continuous Intravenous Infusion in Subjects With Myeloid Malignancies

Clinical Trial IDs

  • ORG STUDY ID: 20120252
  • SECONDARY ID: 2014-004462-20
  • NCT ID: NCT02520427

Conditions

  • Relapsed/Refractory AML
  • Minimal Residual Disease Positive AML
  • Myelodysplastic Syndrome

Interventions

DrugSynonymsArms
AMG 330Group 1: Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Purpose

The purpose of this First-in-Human Phase 1 study is to determine if AMG 330 given as a continuous IV infusion is safe and tolerable in adult subjects that have myeloid malignancies, and to determine the maximum tolerated dose and/or a biologically active dose. The study will be conducted in multiple sites and test increasing doses of AMG 330. The safety of subjects will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests.

Trial Arms

NameTypeDescriptionInterventions
Group 1: Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)Experimental
  • AMG 330
Group 2: Minimal Residual Disease Positive (MRD+) AMLExperimental
  • AMG 330
Group 3: Myelodysplastic syndrome (MDS)Experimental
  • AMG 330
Group 4: R/R AML with alternative pretreatmentExperimental
  • AMG 330
Group 5: R/R AML with alternative dose scheduleExperimental
  • AMG 330

Eligibility Criteria

        Inclusion criteria:

          -  Informed consent provided

          -  18 years or older

          -  Relapsed/refractory AML: AML as defined by the WHO Classification persisting or
             recurring following one or more treatment courses except promyelocytic leukemia (APML)

        Exclusion criteria:

          -  Active extramedullary AML in testes or central nervous system (CNS)

          -  Known hypersensitivity to immunoglobulins or to any other component of the IP
             formulation (eg, sucrose, captisol, potassium, polysorbate 80, citrate, lysine)

          -  Prior malignancy (other than in situ cancer) unless treated with curative intent and
             without evidence of disease for > 1 years before screening
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Subject incidence of adverse events (AEs) as a measure of safety
Time Frame:36 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence of anti-AMG 330 antibody formation
Time Frame:36 months
Safety Issue:
Description:
Measure:Efficacy parameter: Response rate in subjects with relapsed/refractory acute myeloid leukemia
Time Frame:36 months
Safety Issue:
Description:
Measure:Efficacy parameter: Response rate in subjects with myelodysplastic syndrome
Time Frame:36 months
Safety Issue:
Description:
Measure:Efficacy parameter: Response rate in subjects with minimal residual disease (MRD) positive acute myeloid leukemia
Time Frame:36 months
Safety Issue:
Description:
Measure:Efficacy parameter: Duration of response
Time Frame:36 months
Safety Issue:
Description:
Measure:Efficacy parameter: Time to progression
Time Frame:36 months
Safety Issue:
Description:
Measure:Efficacy parameter: Time to response
Time Frame:36 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter: Half-life of AMG 330
Time Frame:32 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter: Steady state concentration of AMG 330
Time Frame:32 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter: Volume of distribution of AMG 330
Time Frame:32 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter: Clearance of AMG 330
Time Frame:32 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Amgen

Trial Keywords

  • Amgen
  • Phase 1
  • Clinical Trial
  • Oncology/Hematology
  • Relapsed/Refractory AML
  • Immunotherapy

Last Updated

July 1, 2021