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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 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.

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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).

Conditions Studied

Multiple Myeloma

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

FieldValue
Enrollment Target 79 participants
Start Date 2014-07-29
Est. Completion 2019-08-01
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT02064387

The ClinicalTrials.gov registry entry for NCT02064387 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (86% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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 reports 9 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.