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NCT02064387 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916
A Phase 1 study of Multiple Myeloma, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 79
- Enrollment target
- 9
- Study locations
NCT02064387: Completed Phase 1 study of Multiple Myeloma, sponsored by GlaxoSmithKline.
NCT02064387 is a Phase 1 study of Multiple Myeloma that has completed, run by GlaxoSmithKline. The registered enrollment target is 79 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (86% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02064387, a Phase 1 study of Multiple Myeloma, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 79 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study will assess the safety, pharmacokinetic (PK), pharmacodynamic (PD) and the therapeutic potential of GSK2857916 in subjects with multiple myeloma (MM) and lymphomas that express B cell maturation antigen (BCMA). The hypothesis is that GSK2857916 can be safely administered to subjects with MM and with BCMA positive malignancies at doses where target engagement can be demonstrated. This study will determine if adequate target engagement of BCMA receptors translates into clinical benefit for subjects with MM and BCMA positive lymphomas. The study will consists of two parts: a Part 1 dose escalation phase and a Part 2 expansion phase for safety, tolerability, PK, PD, and clinical activity testing. The study will enroll a total of approximately 80-95 subjects with relapsed/refractory MM or BCMA-expressing hematologic malignancies. The maximum dose to be administered in this trial will not exceed 5 milligram/kilogram(mg/kg).
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a clinical study 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 inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other medical events
Conditions Studied
Interventions
- DRUG GSK2857916
Study Locations (9)
Massachusetts
- GSK Investigational Site - Boston
New York
- GSK Investigational Site - New York
North Carolina
- GSK Investigational Site - Chapel Hill
Pennsylvania
- GSK Investigational Site - Philadelphia
Texas
- GSK Investigational Site - Dallas
Washington
- GSK Investigational Site - Seattle
British Columbia
- GSK Investigational Site - Vancouver
Ontario
- GSK Investigational Site - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2014-07-29 |
| Est. Completion | 2019-08-01 |
| Phase | Phase 1 |
What the finished NCT02064387 record still lists
NCT02064387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which GSK2857916 is the first listed.
NCT02064387 lists 9 locations in 9 states (Massachusetts, New York, North Carolina).
Frequently Asked Questions
What is clinical trial NCT02064387 about?
NCT02064387 is a clinical study titled "Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916". This study will assess the safety, pharmacokinetic (PK), pharmacodynamic (PD) and the therapeutic potential of GSK2857916 in subjects with multiple myeloma (MM) and lymphomas that express B cell maturation antigen (BCMA). The hypothesis is that GSK2857916 can be safely administered to subjects with ...
What is the current status of trial NCT02064387?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2014-07-29. Estimated completion is 2019-08-01.
What conditions does trial NCT02064387 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT02064387?
The interventions under investigation include: GSK2857916 (DRUG).
Who is sponsoring clinical trial NCT02064387?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02064387 being conducted?
This trial has 9 study locations across Massachusetts, New York, North Carolina, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02064387's enrollment target sits among peer trials
79 202nd of 438 higher than 236 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma 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.
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