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A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients With Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Metastatic or Unresectable Cutaneous Melanoma

Thank you

Trial Information

A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients With Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma


Inclusion Criteria:



- Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma (AJCC
Stage IIIC or IV)

- Presence of NRAS Q61 mutation in tumor tissue prior to randomization

- Naïve untreated patients or patients who have progressed on or after prior first-line
immunotherapy for unresectable locally advanced or metastatic melanoma

- Evidence of at least one measurable lesion as detected by radiological or
photographic methods

- Adequate bone marrow, organ function, cardiac and laboratory parameters

- Normal functioning of daily living activities

Exclusion Criteria:

- Any active/non-stable brain lesion

- Non-cutaneous melanoma

- History of or current evidence of central serous retinopathy (CSR), retinal vein
occlusion (RVO) or history of retinal degenerative disease.

Patients with washout period < 12 weeks from the last dose of ipilimumab or other
immunotherapy.

Previous chemotherapy for unresectable locally advanced or metastatic melanoma.

- History of Gilbert's syndrome

- Prior therapy with a MEK- inhibitor

- Impaired cardiovascular function or clinically significant cardiovascular diseases

- Uncontrolled arterial hypertension despite medical treatment

- HIV positive or active Hepatitis A or B

- Impairment of gastrointestinal function or gastrointestinal disease

- Patients with neuromuscular disorders that are associated with elevated CK.

- Pregnant or nursing (lactating) women

- Medical, psychiatric, cognitive or other conditions that may compromise the patient's
ability to understand the patient information, give informed consent, comply with the
study protocol or complete the study

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Description:

PFS is defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause, whichever occurs first. PFS will be determined by a Blinded Independent Review Committee (BIRC). The local Investigator's assessments will be used as supportive analyses.

Outcome Time Frame:

The final PFS analysis is expected approximately 16 months after FPFV.

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CMEK162A2301

NCT ID:

NCT01763164

Start Date:

July 2013

Completion Date:

May 2016

Related Keywords:

  • Metastatic or Unresectable Cutaneous Melanoma
  • Melanoma
  • Cutaneous melanoma
  • Skin disease
  • Skin cancer
  • Skin Neoplasms
  • Neoplasm Metastasis
  • Melanoma
  • Skin Neoplasms

Name

Location

USC/Kenneth Norris Comprehensive Cancer Center Los Angeles, California  90033
US Oncology Central Monitoring Dallas, Texas  75246
Kaiser Permanente Northwest Dept of Kaiser Northwest (3) Portland, Oregon  97227
Comprehensive Cancer Centers of Nevada CCC of Nevada (1) Las Vegas, Nevada  89109
Methodist Cancer Center Methodist Estabrook Omaha, Nebraska  68114
Sarah Cannon Research Institute SC - 2 Chattanooga, Tennessee  37404
University of South Alabama / Mitchell Cancer Institute SC Mobile, Alabama  36688
Highlands Oncology Group SC Fayetteville, Arkansas  72703
Beverly Hills Cancer Center SC Beverly HIlls, California  90211
California Pacific Medical Center SC San Francisco, California  94115
Stanford University Medical Center SC - 3 Stanford, California  94304
University of Colorado Dept of Oncology Aurora, Colorado  80045
Florida Cancer Specialists Dept of Onc Fort Myers, Florida  33901
Florida Cancer Specialists SC Fort Myers, Florida  33901
Palm Beach Cancer Institute SC-2 West Palm Beach, Florida  33401
Oncology Specialists, SC SC - 5 Park Ridge, Illinois  60068-0736
Goshen Health System Center for Cancer Care SC Goshen, Indiana  46526
University of Iowa Hospitals & Clinics Oncology Iowa City, Iowa  52242
Eastern Maine Medical Center Research Center SC Bangor, Maine  04401
Weinberg Cancer Institute at Franklin Square Hospital Dept of Oncology Baltimore, Maryland  21237-3998
Massachusetts General Hospital SC -6 Boston, Massachusetts  02114
Wayne State University/Karmanos Cancer Institute SC - 1 Detroit, Michigan  48201
University of Minnesota Medical Center SC Minneapolis, Minnesota  55455
Minnesota Oncology Hematology, P.A. Fridley Location Minneapolis, Minnesota  55404
Mercy Medical Research Institute SC-1 Manchester, Missouri  63021
Cooper Cancer Center SC Camden, New Jersey  08103
Hackensack University Medical Center SC-2 Hackensack, New Jersey  07601
Memorial Sloan Kettering Cancer Center Dept Oncology New York, New York  10021
Duke University Medical Center SC-6 Durham, North Carolina  27710
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State University Columbus, Ohio  43210
Oregon Health & Science University SC-7 Portland, Oregon  97239
Northwest Cancer Specialists Compass Oncology - SC Portland, Oregon  97210
St. Luke's Hospital and Health Network SC Bethlehem, Pennsylvania  
Penn State University / Milton S. Hershey Medical Center SC-2 Hershey, Pennsylvania  17033-0850
Thomas Jerfferson University Hospital SC Philadelphia, Pennsylvania  19107-5098
University of Pennsylvania Medical Center SC - 2 Philadephia, Pennsylvania  19104
University of Pittsburgh Medical Center SC-4 Pittsburgh, Pennsylvania  
Baylor College of Medicine Oncology Dallas, Texas  75246
University of Texas Southwestern Medical Center SC (5) Dallas, Texas  75390-8527
University of Texas Health Science Center at Houston SC Houston, Texas  77030