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

NCT02095574 | Withdrawn Phase 1

• 1 other identifier: M13-363
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Relapsed/Refractory Non-Hodgkin's Lymphoma

Keywords

GDC-0199; ADME; Relapsed; Refractory; ABT-199; Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (3)

• 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

• Time to Cmax (Tmax) for ABT-199 and [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

  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 Outcomes (2)

• Number of subjects with adverse events

  At each visit (daily for approximately the first 9 days)

• Percentage of subjects with adverse events

  At each visit (daily for approximately the first 9 days)

Study Arms (1)

[14C]ABT-199

EXPERIMENTAL

Subjects with relapsed or refractory Non-Hodgkin's Lymphoma

Drug: [14C]ABT-199 (GDC-0199)

Interventions

[14C]ABT-199 (GDC-0199) DRUG

\[14C\]ABT-199 will be administered as a single oral administration

[14C]ABT-199

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must have relapsed or refractory disease.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AbbVie: lead
• Genentech, Inc.: collaborator

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Recurrence

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Justin L Ricker, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: March 26, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2015
• Last Updated: August 13, 2014

Record last verified: 2014-08