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Clinical trial

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

ID
Name
20120252
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.
Trial arms
Trial start
2015-10-20
Estimated PCD
2022-01-09
Trial end
2022-01-09
Status
Terminated
Phase
Early phase I
Treatment
AMG 330
0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.
Arms:
Group 1: Relapsed/Refractory Acute Myeloid Leukemia (R/R AML), Group 2: Minimal Residual Disease Positive (MRD+) AML, Group 3: Myelodysplastic syndrome (MDS), Group 4: R/R AML with alternative pretreatment, Group 5: R/R AML with alternative dose schedule
Size
96
Primary endpoint
Subject incidence of adverse events (AEs) as a measure of safety
36 months
Subject incidence of dose-limiting toxicities (DLTs) as a measure of safety
36 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 96, 'type': 'ACTUAL'}}
Updated at
2022-11-14

1 organization

1 product

3 indications

Organization
Amgen
Product
AMG 330
Indication
Relapsed/Refractory Acute Myeloid Leukemia
Indication
Acute Myeloid Leukemia
Indication
Myelodysplastic Syndrome