Clinical Trial Details

NCT ID: NCT03224819
Date Last Changed: October 17, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments using AMG 673 for patients with Acute Myeloid Leukemia

Research Study Title

A Phase 1 First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 673 Administered as Short Term Intravenous Infusions in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Purpose

This is a first-in-human, open-label, phase 1, sequential dose escalation study. AMG 673 will be evaluated as a short term intravenous (IV) infusion in adult subjects with relapsed/refractory AML. The study will be conducted at approximately 7 sites in the United States, Australia and Germany.

To Learn more

Recruitment Details

Phase
Early 1
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Amgen
Duration
22 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • Subjects ≥ 18 years of age.

  • AML as defined by the WHO Classification persisting or recurring following one or more treatment courses except promyelocytic leukemia (APML) and except AML with myelodysplasia related changes.

  • More than 5% white blood cells in bone marrow.

  • ECOG ≤ 2

  • Renal function as follows: serum creatinine < 2.0 mg/dL (176.84 umol/L) and estimated glomerular filtration rate > 30 mL/min/1.73 m2.

  • Hepatic function as follows:

  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3.0 x upper limit of normal (ULN)

  • Bilirubin ≤ 1.5 x ULN (unless considered due to Gilbert's syndrome or hemolysis)

Exclusion Criteria:

  • Active extramedullary AML in testes or central nervous system (CNS)

  • White blood cells (WBC) > 15,000 cells/mcL (15 cells x 10^9/L) at screening. In subjects with WBC > 15,000 cells/mcL at screening with lymphocyte predominance, subject may be deemed eligible for the trial by the Amgen physician, after discussion with the investigator.

  • Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for > 2 years before screening.

  • Autologous HSCT within six weeks prior to start of AMG 673 treatment.

  • Allogeneic HSCT within three months prior to start of AMG 673 treatment.

  • Non-manageable graft versus host disease.

  • Cardiovascular Risks as outlined in the protocol.

  • History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 3 months.

  • Active infection requiring intravenous antibiotics within 1 week of study enrollment (day 1).

  • Known positive test for Human immunodeficiency virus (HIV).

  • Positive for Hepatitis B surface antigen.

  • Positive for Hepatitis C or Chronic Hepatitis C.

  • Unresolved toxicities from prior antitumor therapy, defined as not having resolved to CTCAE, version 4.0 grade 1 (with the exception of myelosuppression, eg, neutropenia, anemia, thrombocytopenia), or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior antitumor therapy that are considered irreversible (defined as having been present and stable for > 2 months) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor.

  • Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, retinoid therapy, or investigational agent) within 14 days or 5 half lives (whichever is longer) of day 1.

  • Treatment with systemic immune modulators including, but not limited to, non-topical systemic corticosteroids, cyclosporine, and tacrolimus within 2 weeks before enrollment (day 1).

  • Prior treatment with a monoclonal antibody or chimeric antigen receptor T cell (CAR-T) infusion for the treatment of AML (CD33 or other target).

  • Prior participation in an investigational study (drug, procedure or device) within 21 days of study day 1.

  • Major surgery within 28 days of study day 1 with the exception of biopsy and insertion of central venous catheter.

Site Locations (1)

Country State City Zip Facility and Contact
United States California Duarte 91010 Research Site

Contact

Amgen Call Center
866-572-6436
E-mail:

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