Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Leukemia

Leukemia, Lymphoid

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Lymphosarcoma

Peripheral T-cell Lymphoma

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

All Drugs and Chemicals

N-(1-(7-fluoro-2-(pyridin-2-yl)quinolin-3-yl)ethyl)-9H-purin-6-amine

Enzyme Inhibitors

Dose selected from Part I dose exploration

The AMG 319 doses proposed for this study are 25, 50, 100, 200, 300 and 400 mg administered by mouth once daily.

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

AMG 319

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.

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

Amgen

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
AMG 319 Lymphoid Malignancy FIH	NCT01300026	Cancer Chronic Lymphoc... Diffuse Large C... Hematologic Mal... Hematology Leukemia Low Grade Lymph... Lymphoma Mantle Cell Lym... Non-Hodgkin's L... Oncology Oncology Patien... T Cell Lymphoma Tumors	AMG 319	18 Years -	Amgen
AMG 319 Lymphoid Malignancy FIH	NCT01300026	Cancer Chronic Lymphoc... Diffuse Large C... Hematologic Mal... Hematology Leukemia Low Grade Lymph... Lymphoma Mantle Cell Lym... Non-Hodgkin's L... Oncology Oncology Patien... T Cell Lymphoma Tumors	AMG 319	18 Years -	Amgen

Spots Global Cancer Trial Database for low intermediate grade b cell lymphoma