A Pharmacokinetic Study to Access How the Body Absorbs and Removes ABT-199 in Adults With Non-Hodgkin's Lymphoma

Relapsed/Refractory Non-Hodgkin's Lymphoma Clinical Trial

Official title:

Disposition of [14C] ABT-199 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) Following a Single Oral Dose Administration

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02095574
• Other study ID #: M13-363
• Status: Withdrawn
• Phase: Phase 1
• First received: January 28, 2014
• Last updated: August 12, 2014
• Start date: September 2014
• Est. completion date: January 2015

Study information

• Verified date: August 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Relapsed/Refractory Non-Hodgkin's Lymphoma

Intervention

Drug:
• [14C]ABT-199 (GDC-0199)
[14C]ABT-199 will be administered as a single oral administration

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of ABT-199 and [14C]ABT-199		For approximately 9 days following a single oral dose of [14C]ABT-199	No
Primary	Time to Cmax (Tmax) for ABT-199 and [14C]ABT-199		For approximately 9 days following a single oral dose of [14C]ABT-199	No
Primary	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	For approximately 9 days following a single oral dose of [14C]ABT-199	No
Secondary	Number of subjects with adverse events	Adverse event monitoring, lab test assessment, physical exam and vital signs will be evaluated throughout the study.	At each visit (daily for approximately the first 9 days)	Yes
Secondary	Percentage of subjects with adverse events	Adverse event monitoring, lab test assessment, physical exam and vital signs will be evaluated throughout the study.	At each visit (daily for approximately the first 9 days)	Yes