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Bcl-2 inhibitor

Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory 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 cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: cycle 1 day 5 (c1d5); cohorts 14 and 15: cycle 1 day 8 (c1d8) (sampling pre-dose up to 72 hours post-dose)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests AMG 427, a new drug, in adults with a specific type of blood cancer. It aims to find the safest and most effective amount of the drug by adjusting the dosage over time.

Eligible Conditions
  • AML

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: cycle 1 day 5 (c1d5); cohorts 14 and 15: cycle 1 day 8 (c1d8) (sampling pre-dose up to 72 hours post-dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cohorts 1, 2, 3, 4, 5, 6, 7a, 7b, 8, 9, 10, 11, 12, 13, 16 and 17: cycle 1 day 5 (c1d5); cohorts 14 and 15: cycle 1 day 8 (c1d8) (sampling pre-dose up to 72 hours post-dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Treatment-related TEAEs
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Secondary study objectives
AUC From Time 0 to Infinity (AUC0-inf) of Emirodatamab
AUC From Time Zero to 14 Days Post-dose (AUC14d) of Emirodatamab
Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of Emirodatamab
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,442 Previous Clinical Trials
1,397,680 Total Patients Enrolled
MDStudy DirectorAmgen
980 Previous Clinical Trials
941,436 Total Patients Enrolled
~9 spots leftby Dec 2025
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