A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies

NCT02520427 | Terminated Phase 1 Results

• 2 other identifiers: 201202522014-004462-20
• Study Type: interventional
• Target: 95
• Locations: 4 countries
• Sites: 11

Brief Summary

The purpose of this First-in-Human Phase 1 study is to determine if AMG 330 given as a continuous IV infusion is safe and tolerable in adult subjects that have myeloid malignancies, and to determine the maximum tolerated dose and/or a biologically active dose. The study will be conducted in multiple sites and test increasing doses of AMG 330. The safety of subjects will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests.

Conditions

Relapsed/Refractory AML; Minimal Residual Disease Positive AML; Myelodysplastic Syndrome

Keywords

Amgen; Phase 1; Clinical Trial; Oncology/Hematology; Relapsed/Refractory AML; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)

  A participant was not DLT-evaluable if they dropped out before completion of the DLT window (14 days) for reasons other than an adverse event related to study drug or the participant had not received investigational product (IP) treatment for at least 14 days at the target dose for a 3- or 4-week cycle or at least 7 days at a target dose for a 2- week cycle. Furthermore, following drug interruptions, if a participant was unable to complete 2 repeat cycles for reasons other than DLT, the participant was not DLT evaluable.

  Day 1 to Day 14

• Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

  The severity of TEAEs were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria. The general guideline for assessment ranged from Grade 1 to 5, with higher grades indicating a worse outcome, and included: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 = death.

  Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days

Secondary Outcomes (16)

• Number of Participants Who Experienced an Incident of Anti-AMG 330 Antibody Formation

  Baseline until the end of study, up to approximately 6 months

• Response Rate in Participants With R/R AML

  From first dose of IP (Day 1) until the end of study, up to approximately 6 months

• Response Rate in Participants With MRD-positive AML

  From first dose of IP (Day 1) until the end of study, up to approximately 6 months

• Response Rate in Participants With MDS

  From first dose of IP (Day 1) until the end of study, up to approximately 6 months

• Duration of Response

  From first dose of IP (Day 1) until the end of study, up to approximately 6 months

Study Arms (5)

Group 1: Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

EXPERIMENTAL

Drug: AMG 330

Group 2: Minimal Residual Disease Positive (MRD+) AML

EXPERIMENTAL

Drug: AMG 330

Group 3: Myelodysplastic syndrome (MDS)

EXPERIMENTAL

Drug: AMG 330

Group 4: R/R AML with alternative pretreatment

EXPERIMENTAL

Drug: AMG 330

Group 5: R/R AML with alternative dose schedule

EXPERIMENTAL

Drug: AMG 330

Interventions

AMG 330 DRUG

0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.

Group 1: Relapsed/Refractory Acute Myeloid Leukemia (R/R AML); Group 2: Minimal Residual Disease Positive (MRD+) AML; Group 3: Myelodysplastic syndrome (MDS); Group 4: R/R AML with alternative pretreatment; Group 5: R/R AML with alternative dose schedule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent provided
• years or older
• Relapsed/refractory AML: AML as defined by the WHO Classification persisting or recurring following one or more treatment courses except promyelocytic leukemia (APML)

You may not qualify if:

• Active extramedullary AML in testes or central nervous system (CNS)
• Known hypersensitivity to immunoglobulins or to any other component of the IP formulation (eg, sucrose, captisol, potassium, polysorbate 80, citrate, lysine)
• Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for \> 1 years before screening

Sponsors & Collaborators

• Amgen: lead

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

Research Site

Duarte, California, 91010, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Universitätsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Klinikum der Universität München Campus Grosshadern

München, 81377, Germany

Location

Universitatsklinikum Ulm

Ulm, 89081, Germany

Location

Research Site

Amsterdam, 1007 MB, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 CE, Netherlands

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Neoplasms

Interventions

AMG 330

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Limitations and Caveats

Group 5 dose-escalation cohort and dose-expansion cohorts were not enrolled in the study, due to the study terminating early.

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: August 11, 2015
• Study Start: August 31, 2015
• Primary Completion: January 9, 2022
• Study Completion: January 9, 2022
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

DE (3); CA (1); NL (2); US (5)