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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 months for reporting.

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 more

20170528 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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

AmgenLead Sponsor

1,380 Previous Clinical Trials

1,379,557 Total Patients Enrolled

MDStudy DirectorAmgen

925 Previous Clinical Trials

926,580 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do any risks accompany the utilization of AMG 427?

"As AMG 427 is in its early testing stages, the safety rating given by Power was a 1. This means that there is limited evidence to support efficacy and safety of this drug."

Answered by AI

Are there any open enrollment opportunities for this research project?

"As indicated by the records maintained on clinicaltrials.gov, this research is accepting volunteers and was first made available to the public in September of 2018 with its most recent update occurring before November 30th 2022."

Answered by AI

How many medical centers are currently involved in this clinical experiment?

"Seven medical centres, including Northwestern University in Evanston and Johns Hopkins in Baltimore, are actively enrolling patients for this trial. Additionally, there are other 4 sites contributing to the recruitment process."

Answered by AI

How many individuals are receiving treatment through this clinical research endeavor?

"Amgen, the trial's sponsor, aims to enroll 200 qualifying patients from different sites including Northwestern University in Evanston and Roswell Park Cancer Institute in Buffalo for this medical research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

2018. "Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03541369.