Back to resultsA Pharmacokinetic Study to Access How the Body Absorbs and Removes ABT-199 in Adults With Non-Hodgkin's Lymphoma
Primary Purpose
Relapsed/Refractory Non-Hodgkin's Lymphoma
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
[14C]ABT-199 (GDC-0199)
Sponsored by
About this trial
This is an interventional basic science trial for Relapsed/Refractory Non-Hodgkin's Lymphoma focused on measuring GDC-0199, ADME, Relapsed, Refractory, ABT-199, Non-Hodgkin's Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Subject must have relapsed or refractory disease.
- Subject must have histologically documented diagnosis of non-hodgkin's lymphoma as defined by a B-cell neo-plasm in the World Health Organization (WHO) classification scheme except as noted in exclusion criteria.
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
- Subject has adequate bone marrow (independent of growth factor support per local laboratory reference range).
- Subject has adequate coagulation, renal and hepatic function.
Exclusion Criteria:
- Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), mantle cell leukemia (MCL), or small lymphocytic lymphoma (SLL).
- Subject has undergone an allogeneic stem cell transplant.
- Subject is receiving combination anti-retroviral therapy for human immunodeficiency virus (HIV) (due to potential drug-drug interactions, as well as the potential for increased risk of opportunistic infections).
- Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease within 6 months that in the opinion of the Investigator would adversely affect his/her participation in this study.
- Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[14C]ABT-199
Arm Description
Subjects with relapsed or refractory Non-Hodgkin's Lymphoma
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax) of ABT-199 and [14C]ABT-199
Time to Cmax (Tmax) for ABT-199 and [14C]ABT-199
Area Under the Time curve (AUC) for ABT-199 and [14C]ABT-199
The area under the exposure-time curve from time zero to Day 9 and time zero extrapolated to infinite time for single dose of [14C]ABT-199
Secondary Outcome Measures
Number of subjects with adverse events
Adverse event monitoring, lab test assessment, physical exam and vital signs will be evaluated throughout the study.
Percentage of subjects with adverse events
Adverse event monitoring, lab test assessment, physical exam and vital signs will be evaluated throughout the study.
Full Information
NCT ID
NCT02095574
First Posted
January 28, 2014
Last Updated
August 12, 2014
Sponsor
AbbVie
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02095574
Brief Title
A Pharmacokinetic Study to Access How the Body Absorbs and Removes ABT-199 in Adults With Non-Hodgkin's Lymphoma
Official Title
Disposition of [14C] ABT-199 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) Following a Single Oral Dose Administration
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Withdrawn
Why Stopped
This study will now be conducted in healthy volunteers.
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
January 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A pharmacokinetic study to access how the body absorbs and removes ABT-199 in adults with Non-Hodgkin's Lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Non-Hodgkin's Lymphoma
Keywords
GDC-0199, ADME, Relapsed, Refractory, ABT-199, Non-Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[14C]ABT-199
Arm Type
Experimental
Arm Description
Subjects with relapsed or refractory Non-Hodgkin's Lymphoma
Intervention Type
Drug
Intervention Name(s)
[14C]ABT-199 (GDC-0199)
Intervention Description
[14C]ABT-199 will be administered as a single oral administration
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) of ABT-199 and [14C]ABT-199
Time Frame
For approximately 9 days following a single oral dose of [14C]ABT-199
Title
Time to Cmax (Tmax) for ABT-199 and [14C]ABT-199
Time Frame
For approximately 9 days following a single oral dose of [14C]ABT-199
Title
Area Under the Time curve (AUC) for ABT-199 and [14C]ABT-199
Description
The area under the exposure-time curve from time zero to Day 9 and time zero extrapolated to infinite time for single dose of [14C]ABT-199
Time Frame
For approximately 9 days following a single oral dose of [14C]ABT-199
Secondary Outcome Measure Information:
Title
Number of subjects with adverse events
Description
Adverse event monitoring, lab test assessment, physical exam and vital signs will be evaluated throughout the study.
Time Frame
At each visit (daily for approximately the first 9 days)
Title
Percentage of subjects with adverse events
Description
Adverse event monitoring, lab test assessment, physical exam and vital signs will be evaluated throughout the study.
Time Frame
At each visit (daily for approximately the first 9 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must have relapsed or refractory disease.
Subject must have histologically documented diagnosis of non-hodgkin's lymphoma as defined by a B-cell neo-plasm in the World Health Organization (WHO) classification scheme except as noted in exclusion criteria.
Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
Subject has adequate bone marrow (independent of growth factor support per local laboratory reference range).
Subject has adequate coagulation, renal and hepatic function.
Exclusion Criteria:
Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), mantle cell leukemia (MCL), or small lymphocytic lymphoma (SLL).
Subject has undergone an allogeneic stem cell transplant.
Subject is receiving combination anti-retroviral therapy for human immunodeficiency virus (HIV) (due to potential drug-drug interactions, as well as the potential for increased risk of opportunistic infections).
Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease within 6 months that in the opinion of the Investigator would adversely affect his/her participation in this study.
Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin L Ricker, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Pharmacokinetic Study to Access How the Body Absorbs and Removes ABT-199 in Adults With Non-Hodgkin's Lymphoma
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