A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies
Phase 1
Suspended
- Conditions
- Relapsed/Refractory AML, Minimal Residual Disease Positive AML, Myelodysplastic Syndrome
- Registration Number
- JPRN-jRCT2071210044
- Lead Sponsor
- Contact Local
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 256
Inclusion 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)
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Subject incidence of adverse events (AEs) as a measure of safety [ Time Frame: 36 months ]<br>2. Subject incidence of dose-limiting toxicities (DLTs) as a measure of safety [ Time Frame: 36 months ]
- Secondary Outcome Measures
Name Time Method 1. Incidence of anti-AMG 330 antibody formation [ Time Frame: 36 months ]<br>2. Efficacy parameter: Response rate in subjects with relapsed/refractory acute myeloid leukemia [ Time Frame: 36 months ]<br>3. Efficacy parameter: Response rate in subjects with myelodysplastic syndrome [ Time Frame: 36 months ]<br>4. Efficacy parameter: Response rate in subjects with minimal residual disease (MRD) positive acute myeloid leukemia [ Time Frame: 36 months ]<br>5. Efficacy parameter: Duration of response [ Time Frame: 36 months ]<br>6. Efficacy parameter: Time to progression [ Time Frame: 36 months ]<br>7. Efficacy parameter: Time to response [ Time Frame: 36 months ]<br>8. Pharmacokinetic parameter: Half-life of AMG 330 [ Time Frame: 32 months ]<br>9. Pharmacokinetic parameter: Steady state concentration of AMG 330 [ Time Frame: 32 months ]<br>10. Pharmacokinetic parameter: Volume of distribution of AMG 330 [ Time Frame: 32 months ]<br>11. Pharmacokinetic parameter: Clearance of AMG 330 [ Time Frame: 32 months ]