Clinical trial · Interventional
A Pharmacokinetic Study to Access How the Body Absorbs and Removes ABT-199 in Adults With Non-Hodgkin's Lymphoma
Disposition of [14C] ABT-199 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) Following a Single Oral Dose Administration
NCT02095574CI-TRIAL-00015382withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study will now be conducted in healthy volunteers.
Summary
Brief summary (as posted)
A pharmacokinetic study to access how the body absorbs and removes ABT-199 in adults with Non-Hodgkin's Lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [14C]ABT-199 (GDC-0199) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [14C]ABT-199
- description
- Subjects with relapsed or refractory Non-Hodgkin's Lymphoma
- interventionNames
- Drug: [14C]ABT-199 (GDC-0199)
Primary outcomes (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.