AMG 319 Lymphoid Malignancy FIH

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Brief Title

AMG 319 Lymphoid Malignancy FIH

Official Title

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

Brief 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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Phospho-AKT level in circulating CLL cells

Condition

Cancer

Intervention

AMG 319

Study Arms / Comparison Groups

 Part II Dose Expansion
Description:  Dose selected from Part I dose exploration

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

28

Start Date

April 2011

Completion Date

December 2016

Primary Completion Date

October 2013

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01300026

Organization ID

20101262

Secondary IDs

AMG 319 FIH Lymphoid

Responsible Party

Sponsor

Study Sponsor

Amgen


Study Sponsor

MD, Study Director, Amgen


Verification Date

February 2017