Clinical Trials /

Study of AMG 673 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

NCT03224819

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Early Phase 1

URL:

https://clinicaltrials.gov/show/NCT03224819

Trial Eligibility

Document

Title

  • Brief Title: Study of AMG 673 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: 20160377
  • NCT ID: NCT03224819

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
AMG 673Expansion Phase

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.

Trial Arms

NameTypeDescriptionInterventions
Exploration PhaseExperimentalDose finding phase of the study
  • AMG 673
Expansion PhaseExperimentalMaximum Tolerated Dose identified by Exploration Phase administered to subjects
  • AMG 673

Eligibility Criteria

        Inclusion Criteria

          -  Subject has provided informed consent prior to initiation of any study-specific
             activities/procedures.

          -  Subjects ≥ 18 years of age at the time of signing consent.

          -  AML as defined by the WHO Classification (Appendix D) persisting or recurring
             following 1 or more treatment courses except promyelocytic leukemia (APML).

        More than 5% myeloblasts in bone marrow.

        -Eastern Cooperative Oncology Group (ECOG, Appendix F) Performance Status of ≤ 2.

        Exclusion Criteria

          -  Known hypersensitivity to immunoglobulins.

          -  Autologous HSCT within 6 weeks prior to start of AMG 673 treatment.

          -  Allogeneic HSCT within 3 months prior to start of AMG 673 treatment.

          -  Non-manageable graft versus host disease.

          -  Known positive test for human immunodeficiency virus (HIV).

          -  Males and females of reproductive potential who are unwilling to practice a highly
             effective method(s) of birth control while on study through 15 weeks after receiving
             the last dose of study drug. Acceptable methods of highly effective birth control
             include sexual abstinence (males, females); vasectomy; bilateral tubal
             ligation/occlusion; or a condom with spermicide (men) in combination with hormonal
             birth control or intrauterine device (IUD) (women). Males who are unwilling to abstain
             from sperm donation while on study through 5 half-lives after receiving the (last
             [multiple-dose studies]) dose of study drug.

          -  Females who are lactating/breastfeeding or who plan to breastfeed while on study
             through 15 weeks after receiving the last dose of study drug.

          -  Females with a positive pregnancy test

          -  Females planning to become pregnant while on study through 15 weeks after receiving
             the last dose of study drug.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Subject incidence and grade of adverse events
Time Frame:18 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Pharmacokinetic parameter - half-life
Time Frame:18 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter - steady state
Time Frame:18 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter - Concentration
Time Frame:18 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter - Volume of distribution
Time Frame:18 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter - Clearance of AMG 673
Time Frame:18 months
Safety Issue:
Description:
Measure:Efficacy parameters - response rate
Time Frame:18 months
Safety Issue:
Description:
Measure:Efficacy parameters - duration of response
Time Frame:18 months
Safety Issue:
Description:
Measure:Efficacy parameters - time to progression
Time Frame:18 months
Safety Issue:
Description:
Measure:Efficacy parameters - time to response
Time Frame:18 months
Safety Issue:
Description:

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Amgen

Last Updated

March 29, 2021