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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: Clinical Trial Phase 1 study, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071 and MEK162.
Interventions
- DRUG MEK162
- DRUG AEB071
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
Why NCT01801358 stopped before completion
NCT01801358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which MEK162 is the first listed.
NCT01801358 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01801358's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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