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

JRCT ID: jRCT2071210044

Registered date:19/07/2021

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Relapsed/Refractory AML, Minimal Residual Disease Positive AML, Myelodysplastic Syndrome
• Date of first enrollment: 20/10/2015
• Target sample size: 256
• Countries of recruitment: United States,Japan,Germany,Japan,Netherlands,Japan
• Study type: Interventional

Intervention(s)

Experimental: Group 1: Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
Experimental: Group 2: Minimal Residual Disease Positive (MRD+) AML
Experimental: Group 3: Myelodysplastic syndrome (MDS)
Experimental: Group 4: R/R AML with alternative pretreatment
Experimental: Group 5: R/R AML with alternative dose schedule

0.5 ug/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.

Outcome(s)

Primary Outcome

1. Subject incidence of adverse events (AEs) as a measure of safety [ Time Frame: 36 months ]
2. Subject incidence of dose-limiting toxicities (DLTs) as a measure of safety [ Time Frame: 36 months ]

Secondary Outcome

1. Incidence of anti-AMG 330 antibody formation [ Time Frame: 36 months ]
2. Efficacy parameter: Response rate in subjects with relapsed/refractory acute myeloid leukemia [ Time Frame: 36 months ]
3. Efficacy parameter: Response rate in subjects with myelodysplastic syndrome [ Time Frame: 36 months ]
4. Efficacy parameter: Response rate in subjects with minimal residual disease (MRD) positive acute myeloid leukemia [ Time Frame: 36 months ]
5. Efficacy parameter: Duration of response [ Time Frame: 36 months ]
6. Efficacy parameter: Time to progression [ Time Frame: 36 months ]
7. Efficacy parameter: Time to response [ Time Frame: 36 months ]
8. Pharmacokinetic parameter: Half-life of AMG 330 [ Time Frame: 32 months ]
9. Pharmacokinetic parameter: Steady state concentration of AMG 330 [ Time Frame: 32 months ]
10. Pharmacokinetic parameter: Volume of distribution of AMG 330 [ Time Frame: 32 months ]
11. Pharmacokinetic parameter: Clearance of AMG 330 [ Time Frame: 32 months ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Informed consent provided
2. 18 years or older
3. Relapsed/refractory AML: AML as defined by the WHO Classification persisting or recurring following one or more treatment courses except promyelocytic leukemia (APML)

Exclude criteria

1. Active extramedullary AML in testes or central nervous system (CNS)
2. Known hypersensitivity to immunoglobulins or to any other component of the IP formulation (eg, sucrose, captisol, potassium, polysorbate 80, citrate, lysine)
3. Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for more than 1 years before screening

Related Information

• Primary Sponsor: Contact Local
• Secondary ID(s): NCT02520427