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
2 other identifiers
interventional
28
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 cancer
Started Apr 2011
Longer than P75 for phase_1 cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2011
CompletedFirst Posted
Study publicly available on registry
February 21, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 9, 2017
February 1, 2017
2.5 years
January 6, 2011
February 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Clinically significant or > or = to Grade 3 CTCAE changes in safety laboratory tests, physical exams, ECGs or vital signs
28 Days after last subject enrolled per each cohort
PK parameters
28 Days after last subject enrolled per each cohort
Clinical/radiological response rate for CLL subjects
With primary analysis
Treatment-emergent adverse events
28 Days after last subject enrolled per each cohort
Secondary Outcomes (2)
Phospho-AKT level in circulating CLL cells
With primary analysis
Number of patients with clinical/radiological response
With primary analysis
Study Arms (2)
Part II Dose Expansion
EXPERIMENTALDose selected from Part I dose exploration
Part I Dose Exploration
EXPERIMENTALThe AMG 319 doses proposed for this study are 25, 50, 100, 200, 300 and 400 mg administered by mouth once daily.
Interventions
AMG 319 is a highly selective, orally bioavailable and potent small molecule inhibitor of PI3Kδ.
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (3)
Research Site
Hackensack, New Jersey, 07601, United States
Research Site
Durham, North Carolina, 27710, United States
Research Site
Salt Lake City, Utah, 84112, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2011
First Posted
February 21, 2011
Study Start
April 1, 2011
Primary Completion
October 1, 2013
Study Completion
December 1, 2016
Last Updated
February 9, 2017
Record last verified: 2017-02