AMG 319 Lymphoid Malignancy FIH
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Cancer, Cancer, Blood Cancer, Lymphoma, Leukemia |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/10/2017 |
| Start Date: | April 2011 |
| End Date: | December 2016 |
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
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.
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.
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
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