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

Sponsor

Amgen (Industry)

Overall Status

Terminated

CT.gov ID

NCT02520427

Collaborator

(none)

Enrollment

Locations

Arms

75.3

Actual Duration (Months)

8.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Relapsed/Refractory AML Minimal Residual Disease Positive AML Myelodysplastic Syndrome	Drug: AMG 330	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 31, 2015

Actual Primary Completion Date :

Dec 9, 2021

Actual Study Completion Date :

Dec 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)	Drug: AMG 330 0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.
Experimental: Group 2: Minimal Residual Disease Positive (MRD+) AML	Drug: AMG 330 0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.
Experimental: Group 3: Myelodysplastic syndrome (MDS)	Drug: AMG 330 0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.
Experimental: Group 4: R/R AML with alternative pretreatment	Drug: AMG 330 0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.
Experimental: Group 5: R/R AML with alternative dose schedule	Drug: AMG 330 0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-3300
2	Research Site	Duarte	California	United States	91010
3	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
4	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
5	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
6	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9
7	Universitätsklinikum Schleswig-Holstein	Kiel		Germany	24105
8	Klinikum der Universität München Campus Grosshadern	München		Germany	81377
9	Universitatsklinikum Ulm	Ulm		Germany	89081
10	Research Site	Amsterdam		Netherlands	1007 MB
11	Erasmus Medisch Centrum	Rotterdam		Netherlands	3015 CE