Relapsed/Refractory Non-Hodgkin's LymphomaPhase 1NCT02095574
A Pharmacokinetic Study to Access How the Body Absorbs and Removes ABT-199 in Adults With Non-Hodgkin's Lymphoma
A Phase 1 study testing [14C]ABT-199 (GDC-0199) in people with Relapsed/Refractory Non-Hodgkin's Lymphoma, run by AbbVie.
Trial summary
A pharmacokinetic study to access how the body absorbs and removes ABT-199 in adults with Non-Hodgkin's Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Non-Hodgkin's Lymphoma
- What is being tested?
- [14C]ABT-199 (GDC-0199)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jan 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have relapsed or refractory disease.
- 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.
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Being tested
- [14C]ABT-199 (GDC-0199)
- Keywords
- GDC-0199, ADME, Relapsed, Refractory, ABT-199, Non-Hodgkin's Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]ABT-199 (GDC-0199)Drug
[14C]ABT-199 will be administered as a single oral administration
| Study group | Role | What they receive |
|---|---|---|
| [14C]ABT-199 | Experimental | Subjects with relapsed or refractory Non-Hodgkin's Lymphoma Receives: Drug: [14C]ABT-199 (GDC-0199) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of ABT-199 and [14C]ABT-199
Measured: For approximately 9 days following a single oral dose of [14C]ABT-199
Time to Cmax (Tmax) for ABT-199 and [14C]ABT-199
Measured: 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
Measured: For approximately 9 days following a single oral dose of [14C]ABT-199
Secondary outcomes (2)
Number of subjects with adverse events
Adverse event monitoring, lab test assessment, physical exam and vital signs will be evaluated throughout the study.
Measured: At each visit (daily for approximately the first 9 days)
Percentage of subjects with adverse events
Adverse event monitoring, lab test assessment, physical exam and vital signs will be evaluated throughout the study.
Measured: At each visit (daily for approximately the first 9 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2014 (estimated)
- Study completionJan 2015 (estimated)
Why it stopped: This study will now be conducted in healthy volunteers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Justin L Ricker, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095574
- Sponsor's protocol ID
- M13-363
- Status last verified
- Aug 2014
- First submitted
- 28 Jan 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disposition of [14C] ABT-199 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) Following a Single Oral Dose Administration
- ClinicalTrials.gov ID
- NCT02095574
- Acronym / sponsor ID
- M13-363
- Keywords
- GDC-0199, ADME, Relapsed, Refractory, ABT-199, Non-Hodgkin's Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study will now be conducted in healthy volunteers.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Sep 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pharmacokinetic study to access how the body absorbs and removes ABT-199 in adults with Non-Hodgkin's Lymphoma.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]ABT-199 | Experimental | Drug: [14C]ABT-199 (GDC-0199)Subjects with relapsed or refractory Non-Hodgkin's Lymphoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must have relapsed or refractory disease.
- 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.
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]ABT-199 (GDC-0199)[14C]ABT-199 will be administered as a single oral administration | Drug | [14C]ABT-199 |
Primary outcome
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
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
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
2 secondary outcomes
Number of subjects with adverse events
Time frame: 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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin L Ricker, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]ABT-199 (GDC-0199) in people with Relapsed/Refractory Non-Hodgkin's Lymphoma, run by AbbVie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.