Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies

ClinicalTrials.gov ID: NCT03465540

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Official title

A Phase 1 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Evaluate the safety and tolerability of AMG 397. Estimate the maximum tolerated doses (MTDs) and/or biologically active doses.

Study identification

NCT ID: NCT03465540
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 1
Lead sponsor: Amgen; Industry
Enrollment: 24 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 17, 2018 (Actual)
Primary completion: Jul 25, 2019 (Actual)
Completion: Jul 25, 2019 (Actual)
Last update posted: Apr 12, 2023

2018 – 2019

United States locations

U.S. sites: 12
U.S. states: 11
U.S. cities: 12

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham	Birmingham	Alabama	35249	—
Mayo Clinic Arizona	Phoenix	Arizona	85054	—
Mayo Clinic Florida	Jacksonville	Florida	32224	—
University of Kansas Cancer Center	Westwood	Kansas	66205	—
University of Maryland Greenebaum Cancer Center	Baltimore	Maryland	21201	—
Dana Farber Cancer Institute	Boston	Massachusetts	02215	—
Mayo Clinic Rochester	Rochester	Minnesota	55905	—
Washington University	St Louis	Missouri	63110	—
Roswell Park Cancer Institute	Buffalo	New York	14263	—
Memorial Sloan Kettering Cancer Center	New York	New York	10065	—
University of Texas MD Anderson Cancer Center	Houston	Texas	77030	—
Froedtert and Med College Wisconsin	Milwaukee	Wisconsin	53226	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03465540, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 12, 2023 · Synced Nov 11, 2026