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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

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


Inclusion Criteria:



- Part 1 (Dose Exploration): Relapsed or refractory lymphoid malignancy of the following
type for which standard treatment does not exist or is no longer effective:

B-cell Chronic Lymphocytic Leukemia (CLL) confirmed by immunophenotype or Non-Hodgkin
Lymphoma: Low or intermediate grade B-cell NHL, mantle cell lymphoma, non-cutaneous T-cell
NHL confirmed by histology and/or immunophenotype

- Part 2 (Dose Expansion): Subjects must have relapsed or refractory B-cell Chronic
Lymphocytic Leukemia confirmed by immunophenotype for which standard treatment does
not exist or is no longer effective.

- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

- Life expectancy of > 3 months, in the opinion of the investigator

- Men or women ≥ 18 years old

- Hematological function, as follows:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (unless due to disease-related bone marrow
involvement as documented by bone marrow biopsy, ≥ 0.5 x 109/L) Platelet count ≥ 50 x
109/L (without a transfusion within 14 days before enrollment) Hemoglobin ≥ 9 g/dL

- Hepatic function, as follows: Aspartate aminotransferase (AST) < 3.0 x ULN Alanine
aminotransferase (ALT) < 3.0 x ULN Alkaline phosphatase (ALP) < 2.0 x ULN (< 5 x ULN in
subjects whom the PI and sponsor agree that clinical data suggest an extrahepatic source
of elevation) Total bilirubin < 1.5 x ULN (< 3.0 x ULN for subjects with documented
Gilbert's Disease or for whom the indirect bilirubin level suggests an extrahepatic source
of elevation) Amylase ≤ 2.0 x IULN Lipase ≤ 2.0 x IULN

Exclusion Criteria:

- Primary or disseminated tumor involving the central nervous system (CNS)

- A history of other malignancies, except: adequately treated non-melanoma skin cancer,
curatively treated in-situ cancer, or other solid tumors curatively treated with no
evidence of disease for ≥ 2 years

- History of allogeneic stem-cell (or other organ) transplantation

- Clinically significant ECG changes which obscure the ability to assess the PR, QT,
and QRS interval; congenital long QT syndrome

- QTcF interval > 470 msec

- Active or chronic hepatitis B or hepatitis C infection, determined by serologic tests

- Recent infection requiring intravenous anti-infective treatment that was completed ≤
14 days before enrollment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinically significant or > or = to Grade 3 CTCAE changes in safety laboratory tests, physical exams, ECGs or vital signs

Outcome Time Frame:

28 Days after last subject enrolled per each cohort

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20101262

NCT ID:

NCT01300026

Start Date:

February 2011

Completion Date:

June 2014

Related Keywords:

  • 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
  • Low intermediate grade B cell Lymphoma
  • Non-cutaneous T-cell NHL
  • Mantle Cell Lymphoma
  • PI3K delta
  • Lymphoid
  • NHL
  • MCL
  • Hematologic
  • CLL
  • Chronic Lymphocytic Leukemia
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, Mantle-Cell
  • Hematologic Neoplasms

Name

Location

Research SiteBelleville, New Jersey  
Research SiteAsheville, North Carolina  
Research SiteIvins, Utah