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

Amgen

Status and phase: Terminated; Phase 1

Conditions: Relapsed/Refractory AML; Minimal Residual Disease Positive AML; Myelodysplastic Syndrome

Treatments: Drug: AMG 330

Study type: Interventional

Funder types: Industry

Identifiers

NCT02520427

20120252

2014-004462-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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95 participants in 5 patient groups

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

Experimental group

Treatment:

Drug: AMG 330

Group 2: Minimal Residual Disease Positive (MRD+) AML

Experimental group

Treatment:

Drug: AMG 330

Group 3: Myelodysplastic syndrome (MDS)

Experimental group

Treatment:

Drug: AMG 330

Group 4: R/R AML with alternative pretreatment

Experimental group

Treatment:

Drug: AMG 330

Group 5: R/R AML with alternative dose schedule

Experimental group

Treatment:

Drug: AMG 330