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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01320085
Recruitment Status : Active, not recruiting
First Posted : March 22, 2011
Last Update Posted : August 2, 2019
Information provided by (Responsible Party):
Array BioPharma

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.

Condition or disease Intervention/treatment Phase
BRAF or NRAS Mutant Metastatic Melanoma Drug: MEK162 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-label Study to Assess the Safety and Efficacy of Oral MEK162 in Adults With Locally Advanced and Unresectable or Metastatic Malignant Cutaneous Melanoma, Harboring BRAFV600 or NRAS Mutations
Study Start Date : March 2011
Actual Primary Completion Date : January 7, 2014
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: BRAFV600 mutant, 45mg bid MEK162
BRAFV600 mutant, 45mg bid MEK162
Drug: MEK162
Experimental: NRAS mutant, 45mg bid MEK162
NRAS mutant, 45mg bid MEK162
Drug: MEK162
Experimental: BRAFV600 mutant, 60mg bid MEK162
BRAFV600 mutant, 60mg bid MEK162
Drug: MEK162

Primary Outcome Measures :
  1. Overall response rate (ORR) - Efficacy [ Time Frame: every 8 weeks up to end of study ]
    The primary objective is to estimate the objective responses rate (ORRs) of MEK162 when administered orally as i. 45mg twice-daily, to adult patients with advanced, unresectable cutaneous malignant melanoma, harboring BRAFV600 or NRAS mutations and ii. 60mg twice-daily, to adult patients with advanced, unresectable cutaneous malignant melanoma, harboring BRAFV600 mutations. ORR is defined as the rate of best overall response (CR+PR), determined by RECIST.

Secondary Outcome Measures :
  1. Progression Free SUurvival (PFS) [ Time Frame: every 8 weeks up to end of study ]
    The key secondary efficacy objective is estimation of progression free survival (PFS) distribution by study arm. PFS is defined as the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause, as per RECIST.

  2. Overall Survival, Duration of response (DoR) and Time to Response [ Time Frame: every 8-12 weeks up to end of study ]
    These endpoints will allow further analysis of the efficacy of MEK162

  3. Frequency and severity of adverse events and changes in laboratory values [ Time Frame: every 30 days after last dose ]
    To characterize safety and tolerability of MEK162

  4. Change in pharmacodynamics pre- and post-dose [ Time Frame: After 15 days of dosing ]
    To measure the changes in molecular markers of cell proliferation/survival pre-vs. post-dose tumor tissues and potential correlation with clinical outcomes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01320085

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United States, Arkansas
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States, 72703
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute Moffitt 5
Tampa, Florida, United States, 33612
United States, Oregon
Oregon Health & Science University OHSU 2
Portland, Oregon, United States, 97239
United States, Pennsylvania
St. Luke's Hospital and Health Network St. Luke's Cancer Network (2)
Bethlehem, Pennsylvania, United States
United States, South Carolina
Cancer Centers of the Carolinas CCC Faris
Greenville, South Carolina, United States, 29605
Novartis Investigative Site
Essen, Germany, 45147
Novartis Investigative Site
Gera, Germany, 07548
Novartis Investigative Site
Kiel, Germany, 24105
Novartis Investigative Site
Muenchen, Germany, 80336
Novartis Investigative Site
Genova, GE, Italy, 16132
Novartis Investigative Site
Napoli, Italy, 80131
Novartis Investigative Site
Amsterdam, Netherlands, 1066 CX
Novartis Investigative Site
Maastricht, Netherlands, 5800
Novartis Investigative Site
Nijmegen, Netherlands, 6525 GA
Novartis Investigative Site
Chur, Switzerland, 7000
Novartis Investigative Site
Zürich, Switzerland, 8091
Sponsors and Collaborators
Array BioPharma
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Study Director: Array BioPharma 303-381-6604

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Array BioPharma Identifier: NCT01320085     History of Changes
Other Study ID Numbers: CMEK162X2201
2010-023412-13 ( EudraCT Number )
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Keywords provided by Array BioPharma:
Metastatic melanoma,
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas