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

August 12, 2014 updated by: AbbVie

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [14C]ABT-199
Subjects with relapsed or refractory Non-Hodgkin's Lymphoma
Drug: [14C]ABT-199 (GDC-0199)
[14C]ABT-199 will be administered as a single oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
For approximately 9 days following a single oral dose of [14C]ABT-199
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
For approximately 9 days following a single oral dose of [14C]ABT-199
Area Under the Time curve (AUC) for ABT-199 and [14C]ABT-199
Time Frame: For approximately 9 days following a single oral dose of [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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with adverse events
Time Frame: At each visit (daily for approximately the first 9 days)
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)
Percentage of subjects with adverse events
Time Frame: At each visit (daily for approximately the first 9 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Collaborators

Genentech, Inc.

Investigators

  • Study Director: Justin L Ricker, MD, AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

March 21, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 12, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M13-363

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relapsed/Refractory Non-Hodgkin's Lymphoma

Clinical Trials on [14C]ABT-199 (GDC-0199)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe