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Study Complete
Sponsor ID
20101262

AMG 319 Lymphoid Malignancy FIH

Sponsor ID
20101262
Clinicaltrials.gov ID
NCT01300026
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 319
Type
Interventional
Masking
None (Open Label)
Enrollment
28
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: 28 Days after last subject enrolled per each cohort

PK parameters

Timeframe: 28 Days after last subject enrolled per each cohort

Clinical/radiological response rate for CLL subjects

Timeframe: With primary analysis

Treatment-emergent adverse events

Timeframe: 28 Days after last subject enrolled per each cohort

Secondary Outcome Measures

Phospho-AKT level in circulating CLL cells

Timeframe: With primary analysis

Number of patients with clinical/radiological response

Timeframe: With primary analysis

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Hackensack, NJ, United States, 07601
Status
Completed
Location
Research Site
Durham, NC, United States, 27710
Status
Recruiting
Location
Research Site
Salt Lake City, UT, United States, 84112
Status
Recruiting
Study Info
Age
18+ years
Condition
  • Cancer - Other
    • Show more
  • Leukemia
  • Lymphoma
  • Blood Cancer (Other)
  • Tumor
    • Sex
    All
    Trial Dates
    Apr 2011 - Oct 2013
    Inclusion and Exclusion 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