Clinical trial NCT02095574: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Relapsed/Refractory Non-Hodgkin's Lymphoma
Keywords: GDC-0199
ADME
Relapsed
Refractory
ABT-199
Non-Hodgkin's Lymphoma
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2014-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A pharmacokinetic study to access how the body absorbs and removes ABT-199 in adults with Non-Hodgkin's Lymphoma.


Eligibility criteria: Inclusion Criteria:

1. Subject must have relapsed or refractory disease.
2. 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.
3. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
4. Subject has adequate bone marrow (independent of growth factor support per local laboratory reference range).
5. Subject has adequate coagulation, renal and hepatic function.

Exclusion Criteria:

1. 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).
2. Subject has undergone an allogeneic stem cell transplant.
3. 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).
4. 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.
5. Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of ABT-199 and [14C]ABT-199
timeFrame: For approximately 9 days following a single oral dose of [14C]ABT-199
measure: Time to Cmax (Tmax) for ABT-199 and [14C]ABT-199
timeFrame: For approximately 9 days following a single oral dose of [14C]ABT-199
measure: Area Under the Time curve (AUC) for ABT-199 and [14C]ABT-199
timeFrame: For approximately 9 days following a single oral dose of [14C]ABT-199
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: At each visit (daily for approximately the first 9 days)
measure: Percentage of subjects with adverse events
timeFrame: At each visit (daily for approximately the first 9 days)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Justin L Ricker, MD
role: STUDY_DIRECTOR
References: