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
18 Years
N/A
Both
BRAF or NRAS Mutant Metastatic Melanoma
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 Grp | Fayetteville, 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 2 | Portland, Oregon 97239 |
| Cancer Centers of the Carolinas CCC Faris | Greenville, South Carolina 29605 |
| H. Lee Moffitt Cancer Center/University of South Florida Moffitt 5 | Tampa, Florida 33612 |
