NL-OMON47322
Completed
Phase 2
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 II study of MEK162 for melanoma harboring BRAFV600 of NRAS mutations
Array Biopharma0 sites31 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Array Biopharma
- Enrollment
- 31
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients age \>\= 18 years
- •2\. Histologically confirmed diagnosis of locally advanced or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not potentially curable with surgery
- •3\. Must have documented presence of somatic BRAFV600 or NRAS mutation in tumor tissue
- •4\. All patients enrolled should provide sufficient fresh or archival tumor sample at baseline to enable central confirmation of BRAF or NRAS mutations and the additional analyses described in the protocol
- •5\. Evidence of measurable tumor disease as per RECIST
- •6\. WHO performance status of 0\-2
- •7\. Adequate organ function and laboratory parameters:
- •ANC \>\= 1\.5 x 109/L
- •Hemoglobin (Hgb) \>\= 10 g/dL
- •Platelets (PLT) \>\= 75 x 109/L
Exclusion Criteria
- •1\. History or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or ophthalmopathy visible at screening that would be considered a risk factor for CSR or RVO
- •2\. Patients with symptomatic CNS metastasis.
- •3\. Prior therapy with a MEK\- inhibitor
- •4\. Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
- •History/evidence of acute coronary syndromes (including MI, unstable angina, CABG, coronary angioplasty, or stenting) \<6 months prior to screening
- •Symptomatic CHF, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality
- •Uncontrolled arterial hypertension, defined as BP \> 140/100 mmHg
- •5\. Known positive serology for HIV, active Hepatitis B, and/or active Hepatitis C infection
- •6\. Any other condition that would, in the Investigator\*s judgment, contraindicate patient\*s participation in the clinical study due to safety concerns or compliance with clinical study procedures , e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.
- •7\. Patients who have received prior systemic anti\-cancer treatment within the following time frames:
Outcomes
Primary Outcomes
Not specified
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