CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 102 enrolled
Drug / intervention
LEE011 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01781572
NCT01781572Phase 2Completed
CompareCT.gov

A Phase Ib/II, Multicenter, Open Label, Study of LEE011 in Combination With MEK162 in Adult Patients With NRAS Mutant Melanoma

Pfizer·interventional·Posted Feb 1, 2013·Updated Dec 7, 2020

In Brief

A Phase 2 clinical trial evaluating LEE011 and MEK162 for Locally Advanced or Metastatic NRAS Mutant Melanoma. Completed, enrolled 102 participants across 17 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocally Advanced or Metastatic NRAS Mutant Melanoma
CountriesAustralia, Germany, Italy, Netherlands, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2013
Enrollment StartJun 1, 2013
Primary CompletionJan 15, 2018
Study CompletionFeb 20, 2018
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 13.4 years ago

Interventions

LEE011drug

LEE011 will be administered orally once daily

MEK162drug

MEK162 will be administered orally twice daily