Primary objectives:-Evaluate the safety and tolerability of AMG 330 in adult subjects with relapsed/refractory acute myeloid leukemia (R/R A ML), MRD+ AML and MDS-Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg,…
ID
Source
Brief title
Condition
- Other condition
- Leukaemias
Synonym
Health condition
beenmergstoornis: MDS (myelodysplastisch syndroom/myelodysplasie)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: subject incidence and grade of adverse events (AEs) and dose limiting
toxicities (DLTs)
Secondary outcome
Evaluate the pharmacokinetics of AMG 330.
Determine the formation of anti-AMG330 antibodies.
Background summary
In this study AMG 330 is studied. The safety and tolerability are evaluated in
adult subjects with relapsed/refractory
AML, MRD+ AML and MDS. The pharmacokinetics and pharmacodynamics are also being
evaluated in this patient population.
During the study the MTD and/ or biologically active dose will be determined.
AMG 330 is not approved by any regulatory organization to treat any type of
cancer.
About 256 patients will participate in this study in The Netherlands, Germany,
Japan and the United States.
Amgen Inc. is funding this clinical study.
Study objective
Primary objectives:
-Evaluate the safety and tolerability of AMG 330 in adult subjects with
relapsed/refractory acute myeloid leukemia (R/R A ML), MRD+ AML and MDS
-Estimate the maximum tolerated dose (MTD) and/or a biologically active dose
(eg, recommended phase 2 dose [RP2D]) of A MG 330 in adult subjects with R/R
AML, MRD+ AML, and MDS
Study design
This is a first-in-human, open-label, phase 1 sequential dose escalation study.
AMG 330 will be evaluated as a cIV infusion in adult subjects with
relapsed/refractory AML(Group 1), MRD+ AML (Group 2), and MDS (Group 3). The
study will be conducted at approximately 17 sites in Germany, the Netherlands,
Japan, Canada, and the United States (US). For all Groups 1-3, enrollment will
occur in parallel, and each Group will progress from the dose escalation to the
dose expansion independently.
Please refer to protocol section 3.1 for more information.
Intervention
Patients will receive diverse doses of AMG 330 per cohort during the escalation
phase.
The AMG 330 dose in the expansion phase is dependent on the MTD that is
determined during the escalation phase.
Study burden and risks
Risk: Adverse events of the study medication AMG 330. During the visits to the
hospital the subject will be monitored for adverse events.
Burden: treatment duration is about 6 months. The duration of each visit will
be about 5 hours. Besides that the patient will be hospitalized at certain time
points in the study.
Minervum 7061
Breda 4817 ZK
NL
Minervum 7061
Breda 4817 ZK
NL
Listed location countries
Age
Inclusion criteria
Subjects >= 18 years of age, AML as defined by the WHO Classification,
persisting or recurring following one or more treatment courses,
relapsed/refractory AML: blasts in bone marrow >5%, Eastern Cooperative
Oncology Group Performance Status of <= 2
Please see protocol section 4.1 for the full list.
Exclusion criteria
Known hypersensitivity to immunoglobulins or to any other component of the IP
formulation (eg, sucrose, 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, History or evidence of
cardiovascular risk, History of arterial thrombosis in the past 3 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 20120252 |
| EudraCT | EUCTR2014-004462-20-NL |
| CCMO | NL52258.029.15 |