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NCT01428492 · ClinicalTrials.gov registry record · Phase 1

Ph 1b Study to Evaluate GSK2110183 in Combination With Bortezomib and Dexamethasone in Subjects With Multiple Myeloma

A Phase 1 study of Multiple Myeloma, sponsored by Novartis.

Completed
Registry status
Phase 1
Development phase
90
Enrollment target
13
Study locations

NCT01428492 is a Phase 1 study of Multiple Myeloma that has completed, run by Novartis. The registered enrollment target is 90 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (84% lower). The trial reports 13 study locations across 12 states.

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The verdict

NCT01428492, a Phase 1 study of Multiple Myeloma, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 1
Development phase
90 participants
Enrollment target
13
Study locations

Study Summary

Phase Ib, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical activity of GSK2110183 dosed in combination with bortezomib and dexamethasone in multiple myeloma (MM) subjects who have failed at least one line of systemic treatment. Part 1 will identify the maximum tolerated dose(s) (MTD) of the combination regimen. Schedule A - GSK2110183 administered once daily with bortezomib (1.3 mg/m2) and dexamethasone (20 mg) given biweekly. Part 2 will further explore the safety, tolerability and clinical activity of the MTD(s) identified in Part 1, including a pharmacokinetic cohort.

Conditions Studied

Interventions

  • DRUG Dexamethasone
  • DRUG Bortezomib
  • DRUG GSK2110183

Study Locations (13)

Other

  • Novartis Investigative Site - Galway
  • Novartis Investigative Site - Taipei

Arizona

  • Novartis Investigative Site - Scottsdale

California

  • Novartis Investigative Site - Duarte

Georgia

  • Novartis Investigative Site - Atlanta

Illinois

  • Novartis Investigative Site - Chicago

New York

  • Novartis Investigative Site - New York

North Carolina

  • Novartis Investigative Site - Chapel Hill

Ohio

  • Novartis Investigative Site - Columbus

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2011-12
Est. Completion 2015-10
Phase Phase 1

Sponsor

Novartis

265 total trials

What the Registry Record Tells You About NCT01428492

The ClinicalTrials.gov registry entry for NCT01428492 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 90 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 (84% lower). The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone is the first listed.

NCT01428492 reports 13 study locations spanning 12 distinct geographic areas - top geographies include Other, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT01428492 about?

NCT01428492 is a clinical study titled "Ph 1b Study to Evaluate GSK2110183 in Combination With Bortezomib and Dexamethasone in Subjects With Multiple Myeloma". Phase Ib, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical activity of GSK2110183 dosed in combination with bortezomib and dexamethasone in multiple myeloma (MM) subjects who have failed at least one line of systemic treatment. Part 1 w...

What is the current status of trial NCT01428492?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2011-12. Estimated completion is 2015-10.

What conditions does trial NCT01428492 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT01428492?

The interventions under investigation include: Dexamethasone (DRUG), Bortezomib (DRUG), GSK2110183 (DRUG).

Who is sponsoring clinical trial NCT01428492?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01428492 being conducted?

This trial has 13 study locations across Arizona, California, Georgia, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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