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Kinase Inhibitor

MEK162 for Solid Tumors

Phase 1 & 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]), or confirmed diagnosis of non-resectable advanced metastatic colorectal cancer (mCRC), or any other indication upon agreement with the Sponsor, whose disease has progressed despite previous antineoplastic therapy or for whom no further effective standard therapy is available
Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase 2: from date of start of study treatment until date of death or censoring date (maximum exposure of treatment in phase 2 was 111.5 months)
Awards & highlights

Study Summary

This trial is testing the safety and efficacy of two or three drugs to treat patients with advanced solid tumors. The trial will enroll at least 18 patients for the dual combination and at least 12 patients for the triple combination.

Eligible Conditions
  • Solid Tumors with BRAF V600 Mutation

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase 2: from date of start of study treatment until date of death or censoring date (maximum exposure of treatment in phase 2 was 111.5 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 2: from date of start of study treatment until date of death or censoring date (maximum exposure of treatment in phase 2 was 111.5 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Control Rate (DCR) at Week 16: Phase 2, Arm 1 (mCRC Participants)
Number of Participants With Dose Limiting Toxicities (DLTs): Phase 1b
Objective Response Rate (ORR): Phase 2, Arms 2, 3 and A
Secondary outcome measures
AUClast at Steady State (AUClast,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
AUCtau at Steady State (AUCtau,ss) of Encorafenib, Binimetinib and Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Accumulation Ratio (RA) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
+16 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: triple combinationExperimental Treatment3 Interventions
LGX818 QD and MEK162 BID and LEE011 QD 3 weeks on, 1 week off.
Group II: dual combinationExperimental Treatment2 Interventions
LGX818 QD and MEK162 BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LGX818
2012
Completed Phase 2
~630
MEK162
2013
Completed Phase 3
~1520
LEE011
2014
Completed Phase 3
~1960

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,556 Previous Clinical Trials
10,907,030 Total Patients Enrolled
Pfizer Pfizer CT.gov Call CenterStudy DirectorPfizer
21 Previous Clinical Trials
6,104 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What diseases are typically targeted by LEE011?

"LEE011 is often prescribed to patients suffering from neoplasms, braf v600e mutation, metastatic melanoma, and unresectable melanoma."

Answered by AI

What is the ultimate aim of this research endeavor?

"The primary objective of this 14-month clinical trial is to determine the Maximum Tolerated Dose (MTD) based on the incidence of dose limiting toxicities (DLT). Additionally, researchers will measure plasma concentrations for pharmacokinetics and evaluate preliminary anti-tumor activity through an objective response rate. Finally, safety and tolerability must be evaluated by assessing adverse events throughout the study period."

Answered by AI

What other research projects have been conducted featuring LEE011?

"At present, there are 109 active clinical trials focusing on LEE011 with 11 of these in Phase 3. Camperdown, New South Wales is home to several of the LEE011 experiments and 4959 sites worldwide are taking part in its research."

Answered by AI

What is the capacity of participants for this exploration?

"At this moment, the clinical trial is not enrolling patients. First posted on May 30th 2012 and last updated November 22nd 2022, it has since been discontinued. For those seeking other studies, there are 2374 solid tumors containing a BRAF V600 mutation trials actively recruiting participants as well as 109 LEE011 ones doing so too."

Answered by AI

How many health care institutions are administering this experiment within the state?

"Patients with the relevant medical condition can be enrolled in this trial at MD Anderson Cancer Center (Houston, Texas), Ophthalmic Consultants of Boston Inc. (Montreal, Quebec) and Sir Mortimer B. Davis-Jewish General Hospital (Tampa, Florida) plus 8 other sites."

Answered by AI

Is there any remaining capacity for participants in this research endeavor?

"This research has concluded its recruitment stage, having initially been posted on May 30th 2012 and lastly edited November 22nd 2022. For those still looking for trials to join, there are 2374 clinical studies actively enrolling patients with solid tumors harbouring a BRAF V600 mutation and 109 more specifically targeting LEE011."

Answered by AI

Is this endeavor a pioneering trial?

"Research into LEE011 has been conducted since 2011, when Pfizer sponsored the first trial involving 183 participants. This study led to Phase 2 drug approval for this medication in the same year. Currently there are 109 active trials of LEE011 being held across 54 nations and 1507 cities."

Answered by AI
~15 spots leftby Mar 2025