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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
BRAF or NRAS Mutant Metastatic Melanoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate (ORR) - Efficacy

Outcome Description:

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.

Outcome Time Frame:

every 8 weeks up to end of study

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CMEK162X2201

NCT ID:

NCT01320085

Start Date:

March 2011

Completion Date:

October 2014

Related Keywords:

  • BRAF or NRAS Mutant Metastatic Melanoma
  • Metastatic melanoma,
  • BRAF-mutant,
  • NRAS-mutant
  • Melanoma

Name

Location

Highlands Oncology Group Dept of Highlands Oncology GrpFayetteville, Arkansas  72703
St. Luke's Hospital and Health Network St. Luke's Cancer Network (2)Bethlehem, Pennsylvania  
Dana Farber Cancer Institute DFCI (4)Boston, Massachusetts  02115
Oregon Health & Science University OHSU 2Portland, Oregon  97239
Cancer Centers of the Carolinas CCC FarisGreenville, South Carolina  29605
H. Lee Moffitt Cancer Center/University of South Florida Moffitt 5Tampa, Florida  33612