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Trial record 32 of 198 for:    Venetoclax AND ABT-199

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

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ClinicalTrials.gov Identifier: NCT02095574
Recruitment Status : Withdrawn (This study will now be conducted in healthy volunteers.)
First Posted : March 26, 2014
Last Update Posted : August 13, 2014
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie

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

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Non-Hodgkin's Lymphoma Drug: [14C]ABT-199 (GDC-0199) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : September 2014
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Venetoclax

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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095574


Sponsors and Collaborators
AbbVie
Genentech, Inc.
Investigators
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Study Director: Justin L Ricker, MD AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02095574     History of Changes
Other Study ID Numbers: M13-363
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by AbbVie:
GDC-0199
ADME
Relapsed
Refractory
ABT-199
Non-Hodgkin's Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Venetoclax
Antineoplastic Agents