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NCT02144038 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety and Effectiveness of LGH447 and BYL719 in Patients With Relapsed and Refractory Multiple Myeloma
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02144038 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 20 participants.
The verdict
NCT02144038, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a Phase Ib/II study with the primary purpose of the Phase Ib part being to estimate the MTD and/or recommended phase 2 dose (RP2D) of the combination of LGH447 and BYL719 when administered orally to adult patients with relapsed and refractory multiple myeloma. Once the MTD and/or RP2D is determined for the combination of LGH447 and BYL719, additional patients will be enrolled in the Phase II part to determine whether the combination of LGH447 and BYL719 exhibits improved anti-multiple myeloma activity compared to single agent LGH447. This trial never made it to the Phase II part of the this trial.
Interventions
- DRUG BYL719
- DRUG LGH447
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-07-23 |
| Est. Completion | 2015-10-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02144038
The ClinicalTrials.gov registry entry for NCT02144038 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which BYL719 is the first listed.
NCT02144038 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02144038 about?
NCT02144038 is a clinical study titled "Study of the Safety and Effectiveness of LGH447 and BYL719 in Patients With Relapsed and Refractory Multiple Myeloma". This is a Phase Ib/II study with the primary purpose of the Phase Ib part being to estimate the MTD and/or recommended phase 2 dose (RP2D) of the combination of LGH447 and BYL719 when administered orally to adult patients with relapsed and refractory multiple myeloma. Once the MTD and/or RP2D is det...
What is the current status of trial NCT02144038?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2014-07-23. Estimated completion is 2015-10-28.
What interventions are being tested in trial NCT02144038?
The interventions under investigation include: BYL719 (DRUG), LGH447 (DRUG).
Who is sponsoring clinical trial NCT02144038?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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