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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

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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