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NCT01781572 · ClinicalTrials.gov registry record · Phase 1
A Phase Ib/II Study of LEE011 in Combination With MEK162 in Patients With NRAS Mutant Melanoma
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
NCT01781572 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 102 participants.
The verdict
NCT01781572, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
Study Summary
In the phase Ib, the primary purpose is to establish the maximum tolerated dose (MTD)(s)/recommended phase ll dose (RP2D) and schedule of LEE011 and MEK162 orally administered combination. Once the MTD(s)/RP2D have been determined for each tested schedule, additional patients will be enrolled in the phase II portion of the study at the RP2D on the chosen schedule in order to assess the anti-tumor activity of the combination in addition to continued evaluation of safety.
Interventions
- DRUG LEE011
- DRUG MEK162
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2013-06 |
| Est. Completion | 2018-02-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01781572
The ClinicalTrials.gov registry entry for NCT01781572 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which LEE011 is the first listed.
NCT01781572 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01781572 about?
NCT01781572 is a clinical study titled "A Phase Ib/II Study of LEE011 in Combination With MEK162 in Patients With NRAS Mutant Melanoma". In the phase Ib, the primary purpose is to establish the maximum tolerated dose (MTD)(s)/recommended phase ll dose (RP2D) and schedule of LEE011 and MEK162 orally administered combination. Once the MTD(s)/RP2D have been determined for each tested schedule, additional patients will be enrolled in the...
What is the current status of trial NCT01781572?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2013-06. Estimated completion is 2018-02-20.
What interventions are being tested in trial NCT01781572?
The interventions under investigation include: LEE011 (DRUG), MEK162 (DRUG).
Who is sponsoring clinical trial NCT01781572?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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