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Bcl-2 inhibitor
AMG 427 for Acute Myeloid Leukemia (20170528 Trial)
Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months
Awards & highlights
20170528 Trial Summary
This trial is testing a new cancer drug to see if it is safe and works well against relapsed or refractory AML.
Eligible Conditions
- Relapsed/Refractory Acute Myeloid Leukemia
20170528 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of subjects who experience a dose limiting toxicity (DLT)
Subject incidence of treatment-emergent adverse events (TEAEs)
Subject incidence of treatment-related adverse events (TRAEs)
Secondary outcome measures
Area under the concentration-time curve (AUC) of AMG 427
Complete remission with partial hematologic recovery (CRh)
Complete response/remission [CR]
+7 more20170528 Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion PhaseExperimental Treatment1 Intervention
AMG 427 MTD identified in dose escalation phase (or lower) will be administered to subjects.
Group II: Dose Escalation PhaseExperimental Treatment1 Intervention
AMG 427 Dose-finding phase of the study
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Who is running the clinical trial?
AmgenLead Sponsor
1,382 Previous Clinical Trials
1,379,619 Total Patients Enrolled
MDStudy DirectorAmgen
928 Previous Clinical Trials
926,666 Total Patients Enrolled
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