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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: Completed Phase 1 study of Multiple Myeloma, sponsored by Novartis.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Dose and schedule determined using adverse events and changes in safety assessments (laboratory parameters, vital signs and ECG parameters). Recommended Phase 2 Dose (RP2D) will be defined in Part 1. The specific number of subjects to be enrolled is dependent on the number of dose limiting toxicities (DLTs) reported; enrollment of up to 45 subjects in Part 1 is estimated. Subjects will continue on study from the date of randomization until the date of the first documented disease progression or
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
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-10 |
| Phase | Phase 1 |
What the finished NCT01428492 record still lists
NCT01428492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (84% lower).
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 lists 13 locations in 12 states (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.
Learn More About Clinical Trials
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Where NCT01428492's enrollment target sits among peer trials
90 184th of 438 higher than 250 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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