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

NCT02520427 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2024-07-31

Study results available
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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

Interventions

DRUG

AMG 330

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2022-01-09
Completion
2022-01-09

Countries

  • United States
  • Canada
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02520427 on ClinicalTrials.gov