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NCT01801358 · ClinicalTrials.gov registry record · Phase 1
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
A Phase 1 study, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01801358 is a Phase 1 study that was terminated before completion, run by Array Biopharma, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 38 participants.
The verdict
NCT01801358, a Phase 1 study, was terminated before completion, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed
Interventions
- DRUG MEK162
- DRUG AEB071
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01801358
The ClinicalTrials.gov registry entry for NCT01801358 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Array Biopharma, now a wholly owned subsidiary of Pfizer, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MEK162 is the first listed.
NCT01801358 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01801358 about?
NCT01801358 is a clinical study titled "A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma". A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determine...
What is the current status of trial NCT01801358?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2013-08. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01801358?
The interventions under investigation include: MEK162 (DRUG), AEB071 (DRUG).
Who is sponsoring clinical trial NCT01801358?
This trial is sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer, which has 21 total clinical trials registered on ClinicalTrials.gov.
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