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

Myelodysplastic Syndrome Clinical Trial

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 Details — Status: Terminated

Administrative data

• NCT number: NCT02520427
• Other study ID #: 20120252
• Secondary ID: 2014-004462-20
• Status: Terminated
• Phase: Phase 1
• Start date: October 20, 2015
• Est. completion date: January 9, 2022

Study information

• Verified date: November 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: January 9, 2022
• Est. primary completion date: January 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Minimal Residual Disease Positive AML
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Neoplasm, Residual
• Relapsed/Refractory AML

Intervention

Drug:
• AMG 330
0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Germany	Universitätsklinikum Schleswig-Holstein	Kiel
Germany	Klinikum der Universität München Campus Grosshadern	München
Germany	Universitatsklinikum Ulm	Ulm
Netherlands	Research Site	Amsterdam
Netherlands	Erasmus Medisch Centrum	Rotterdam
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Research Site	Duarte	California
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject incidence of adverse events (AEs) as a measure of safety		36 months
Primary	Subject incidence of dose-limiting toxicities (DLTs) as a measure of safety		36 months
Secondary	Incidence of anti-AMG 330 antibody formation		36 months
Secondary	Efficacy parameter: Response rate in subjects with relapsed/refractory acute myeloid leukemia		36 months
Secondary	Efficacy parameter: Response rate in subjects with myelodysplastic syndrome		36 months
Secondary	Efficacy parameter: Response rate in subjects with minimal residual disease (MRD) positive acute myeloid leukemia		36 months
Secondary	Efficacy parameter: Duration of response		36 months
Secondary	Efficacy parameter: Time to progression		36 months
Secondary	Efficacy parameter: Time to response		36 months
Secondary	Pharmacokinetic parameter: Half-life of AMG 330		32 months
Secondary	Pharmacokinetic parameter: Steady state concentration of AMG 330		32 months
Secondary	Pharmacokinetic parameter: Volume of distribution of AMG 330		32 months
Secondary	Pharmacokinetic parameter: Clearance of AMG 330		32 months

External Links

•   AmgenTrials clinical trials website