NCT01320085

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_2

Geographic Reach
5 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

March 24, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2014

Completed
7 years until next milestone

Results Posted

Study results publicly available

January 5, 2021

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2023

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

2.8 years

First QC Date

March 14, 2011

Results QC Date

December 9, 2020

Last Update Submit

January 3, 2024

Conditions

BRAF or NRAS Mutant Metastatic Melanoma

Keywords

Metastatic melanoma,BRAF-mutant,NRAS-mutant

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Objective Response (OR)

    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 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.

    From date of randomization or date of start of treatment until date of first documentation of PD or death due to any cause, whichever occurred first (maximum duration of up to 33 months)

Secondary Outcomes (29)

  • Progression-Free Survival (PFS)

    From date of randomization or date of start of treatment until date of first documentation of PD or date of death due to any cause or date of data censoring, whichever occurred first (maximum duration of up to 33 months)

  • Overall Survival (OS)

    From date of randomization or date of start of treatment to date of death due to any cause or date of censoring, whichever occurred first (maximum duration of up to 33 months)

  • Duration of Response (DOR)

    From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum duration of up to 33 months)

  • Time to Response (TTR)

    From the date of randomization or date of start of treatment to the first documentation of objective response (CR or PR) or data censoring date, whichever occurred first (maximum duration of up to 33 months)

  • Number of Participants With Grade 3 or 4 Treatment-Emergent Adverse Reactions Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.0

    Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 11 years, approximately)

  • +24 more secondary outcomes

Study Arms (3)

BRAFV600 mutant, 45mg bid MEK162

EXPERIMENTAL

BRAFV600 mutant, 45mg bid MEK162

Drug: MEK162

NRAS mutant, 45mg bid MEK162

EXPERIMENTAL

NRAS mutant, 45mg bid MEK162

Drug: MEK162

BRAFV600 mutant, 60mg bid MEK162

EXPERIMENTAL

BRAFV600 mutant, 60mg bid MEK162

Drug: MEK162

Interventions

MEK162DRUG
BRAFV600 mutant, 45mg bid MEK162BRAFV600 mutant, 60mg bid MEK162NRAS mutant, 45mg bid MEK162

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Locally advanced or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not potentially curable with surgery
  • BRAF or NRAS mutation in tumor tissue
  • All patients enrolled should provide sufficient fresh or archival tumor sample at baseline to enable confirmation of BRAF or NRAS mutations and the additional analyses described in the protocol
  • Evidence of measurable tumor disease as per RECIST
  • WHO performance status of 0-2
  • Adequate organ function and laboratory parameters

You may not qualify if:

  • History or evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or any eye condition that would be considered a risk factor for CSR or RVO
  • Patients with unstable CNS metastasis
  • Prior treatment with a MEK- inhibitor
  • Impaired cardiovascular function
  • HIV, active Hepatitis B, and/or active Hepatitis C infection
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential UNLESS they comply with protocol contraceptive requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Highlands Oncology Group

Fayetteville, Arkansas, 72703-4005, United States

Location

H. Lee Moffitt Cancer Center & Research Institute, Inc.

Tampa, Florida, 33612, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97201, United States

Location

OHSU Center for Health and Healing

Portland, Oregon, 97239, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Cancer Care Associates Medical Oncology

Allentown, Pennsylvania, 18104, United States

Location

St. Luke's Cancer Center - Allentown Campus

Allentown, Pennsylvania, 18104, United States

Location

Cancer Care Associates Medical Oncology

Bethlehem, Pennsylvania, 18015, United States

Location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

St. Luke's Hospital - Quakertown Campus

Quakertown, Pennsylvania, 18951, United States

Location

LMU Klinikum der Universität

Munich, Bavaria, 80337, Germany

Location

LMU Klinikum der Universität München

München, Bavaria, 80337, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45122, Germany

Location

Universitatsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

Universitatsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, D-24105, Germany

Location

Universitatsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23562, Germany

Location

SRH Wald-Klinikum Gera GmbH

Gera, Thuringia, 07548, Germany

Location

LMU Klinikum der Universität München

Munich, 80337, Germany

Location

Istituto nazionale Per la Ricerca sul Cancro

Genova, 16132, Italy

Location

Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale

Napoli, 80131, Italy

Location

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Slotervaartziekenhuis

Amsterdam, North Holland, 1066 EC, Netherlands

Location

Universitätsspital Zürich

Zürich (de), 08091, Switzerland

Location

Related Publications (1)

  • Ascierto PA, Schadendorf D, Berking C, Agarwala SS, van Herpen CM, Queirolo P, Blank CU, Hauschild A, Beck JT, St-Pierre A, Niazi F, Wandel S, Peters M, Zubel A, Dummer R. MEK162 for patients with advanced melanoma harbouring NRAS or Val600 BRAF mutations: a non-randomised, open-label phase 2 study. Lancet Oncol. 2013 Mar;14(3):249-56. doi: 10.1016/S1470-2045(13)70024-X. Epub 2013 Feb 13.

    PMID: 23414587DERIVED

MeSH Terms

Conditions

Hereditary Sensory and Autonomic NeuropathiesMelanoma

Interventions

binimetinib

Condition Hierarchy (Ancestors)

Nervous System MalformationsNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 22, 2011

Study Start

March 24, 2011

Primary Completion

January 7, 2014

Study Completion

February 6, 2023

Last Updated

January 24, 2024

Results First Posted

January 5, 2021

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

More information

Locations

US(10)DE(8)IT(2)NL(4)CH(1)