NCT01300026

AMG 319 Lymphoid Malignancy FIH

A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 319 in Adult Subjects With Relapsed or Refractory Lymphoid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	AMG 319	AMG 319 is a highly selective, orally bioavailable and potent small molecule inhibitor of PI3Kδ.

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-10-01
• Completion: 2016-12-01
• First posted: 2011-02-21
• Last updated: 2017-02-09

Locations

3 sites across 1 country: United States