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NCT02082977 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma
A Phase 1 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT02082977: Clinical Trial Phase 1 study, sponsored by GlaxoSmithKline.
NCT02082977 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02082977, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, 2-part study to determine the recommended Phase 2 dose (RP2D) for GSK2816126 given twice weekly by intravenous (IV) infusion. Part 1 will be conducted in adult subjects with relapsed/refractory diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma (tFL), other Non-Hodgkin's lymphomas (NHL), solid tumors (including castrate resistant prostate cancer) and multiple myeloma (MM) to determine the safety and tolerability of GSK2816126. Expansion cohorts (Part 2) are planned to further explore clinical activity of GSK2816126 at the RP2D in subjects with Enhancer of Zeste 2 (EZH2) wild type and EZH2 mutant positive germinal center B-cell like diffuse large B cell lymphoma (GCB-DLBCL), tFL and MM.
Primary Outcome
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associate
Interventions
- DRUG GSK2816126
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2014-04-24 |
| Est. Completion | 2017-06-20 |
| Phase | Phase 1 |
Why NCT02082977 stopped before completion
NCT02082977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 1 intervention - of which GSK2816126 is the first listed.
NCT02082977 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02082977 about?
NCT02082977 is a clinical study titled "A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma". This is an open-label, multicenter, 2-part study to determine the recommended Phase 2 dose (RP2D) for GSK2816126 given twice weekly by intravenous (IV) infusion. Part 1 will be conducted in adult subjects with relapsed/refractory diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma...
What is the current status of trial NCT02082977?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2014-04-24. Estimated completion is 2017-06-20.
What interventions are being tested in trial NCT02082977?
The interventions under investigation include: GSK2816126 (DRUG).
Who is sponsoring clinical trial NCT02082977?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02082977's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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