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Terminated/Withdrawn
Sponsor ID
20160377

Study of AMG 673 in subjects with Relapsed/Refractory Acute Myeloid Leukemia

Sponsor ID
20160377
Clinicaltrials.gov ID
NCT03224819
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Early Phase 1
Product
AMG 673
Type
Interventional
Masking
None (Open Label)
Enrollment
46
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject incidence and grade of adverse events

Timeframe: 18 months

Dose limiting toxicities (DLTs)

Timeframe: 18 Months

Secondary Outcome Measures

Pharmacokinetic parameter - half-life

Timeframe: 18 months

Pharmacokinetic parameter - steady state

Timeframe: 18 months

Pharmacokinetic parameter – Concentration

Timeframe: 18 months

Pharmacokinetic parameter – Volume of distribution

Timeframe: 18 months

Pharmacokinetic parameter – Clearance of AMG 673

Timeframe: 18 months

Efficacy parameters - response rate

Timeframe: 18 months

Efficacy parameters - duration of response

Timeframe: 18 months

Efficacy parameters - time to progression

Timeframe: 18 months

Efficacy parameters - time to response

Timeframe: 18 months

Locations

Location
Status
Contact Us
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
University of Texas MD Anderson Cancer Center
Houston, TX, United States, 77030
Status
Recruiting
Location
The Alfred Hospital
Melbourne, VIC, Australia, 3004
Status
Recruiting
Location
The Royal Melbourne Hospital
Parkville, VIC, Australia, 3050
Status
Recruiting
Location
Klinikum der Ludwig Maximilians Univeritaet
München, Germany, 81377
Status
Recruiting
Location
University of Alabama at Birmingham
Birmingham, AL, United States, 35294
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Leukemia
    • Sex
    All
    Trial Dates
    Sep 2017 - Dec 2020
    Inclusion and Exclusion 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.