AMG 319 Lymphoid Malignancy FIH

Status Completed

Clinical Trial Summary

This is a multi-center, phase 1, open-label first-in-human study of AMG 319 in subjects with relapsed or refractory lymphoid malignancies. This study consists of two parts. The dose exploration in part 1, studies cohorts of 3 subjects with relapsed or refractory lymphoid malignancies and uses a practical continuous reassessment model [CRM] to guide dose escalation and to define the MTD. The dose expansion in part 2 will enroll 20 subjects with CLL at a dose no higher than the MTD and further explore the safety, PK, and clinical activity of AMG 319 in this patient population.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Cancer
Chronic Lymphocytic Leukemia
Diffuse Large Cell Lymphoma
Hematologic Malignancies
Hematology
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Low Grade Lymphoma
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Mantle Cell Lymphoma
Neoplasms
Non-Hodgkin's Lymphoma
Oncology
Oncology Patients
T Cell Lymphoma
Tumors

Clinical Trial Details

NCT number	NCT01300026
Study type	Interventional
Source	Amgen
Contact
Status	Completed
Phase	Phase 1
Start date	April 2011
Completion date	December 2016

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