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NCT01320085 · ClinicalTrials.gov registry record · Phase 2

A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma

A Phase 2 study, sponsored by Pfizer.

Completed
Registry status
Phase 2
Development phase
183
Enrollment target

NCT01320085: Completed Phase 2 study, sponsored by Pfizer.

NCT01320085 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 183 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01320085, a Phase 2 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 2
Development phase
183 participants
Enrollment target

Study Summary

The study will assess the safety and efficacy of single-agent MEK162 in adult patients with locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring BRAFV600E or NRAS mutations.

Primary Outcome

Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.0, was defined as participants with a best overall response of complete response (CR) or partial response (PR), were recorded from date of randomization or date of start of treatment until date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target and non-target lesions, and sustained for at least

Interventions

  • DRUG MEK162

Trial Details

FieldValue
Enrollment Target 183 participants
Start Date 2011-03-24
Est. Completion 2023-02-06
Phase Phase 2
Pfizer

1,845 total trials

What the finished NCT01320085 record still lists

NCT01320085 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher).

The record links to 0 conditions, and to 1 intervention - of which MEK162 is the first listed.

NCT01320085 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01320085 about?

NCT01320085 is a clinical study titled "A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma". The study will assess the safety and efficacy of single-agent MEK162 in adult patients with locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring BRAFV600E or NRAS mutations.

What is the current status of trial NCT01320085?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 183 participants. The study started on 2011-03-24. Estimated completion is 2023-02-06.

What interventions are being tested in trial NCT01320085?

The interventions under investigation include: MEK162 (DRUG).

Who is sponsoring clinical trial NCT01320085?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01320085's enrollment target sits among peer trials

183 363rd of 2000 higher than 1,638 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01320085, the US trial registry maintained by the National Library of Medicine. NCT01320085 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.