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

Array BioPharma Inc.0 sites170 target enrollmentJanuary 13, 2011

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Array BioPharma Inc.
Enrollment: 170
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 13, 2011

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Array BioPharma Inc.

Eligibility Criteria

Inclusion Criteria

•Patients eligible for inclusion in this study have to meet all of the following 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 (Appendix 1\)
•3\. Must have documented presence of somatic BRAFV600 or NRAS mutation in tumor tissue (\*melanoma histologies positive for other activating BRAF mutations may be considered upon approval by the Array Medical Monitor).
•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 (Appendix 2\), defined as at least one lesion that can accurately be measured in at least one dimension as \= 20 mm by conventional radiological technique or \= 10 mm with spiral CT\-scan. Cutaneous lesions must have clearly defined margins and measure \= 5 mm in at least one diameter and be documented by color photography. Target lesions should not be selected in previously irradiated fields unless there is clear evidence of progression in such lesions.
•6\. WHO performance status of 0\-2
•7\. Adequate organ function and laboratory parameters as defined in teh protocol
•8\. Recovery from all reversible adverse events of previous anti\-cancer therapies to baseline or to Grade \= 1, except for alopecia and Grade \<2 sensory PNP
•9\. LVEF \= 50% as determined by MUGA scan or TTE

Exclusion Criteria

•Patients eligible for this study must not meet any of the following criteria at screening:
•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 CNS metastasis unless previously treated with surgery, whole\-brain radiation or stereotactic radiosurgery and the disease has been stable for at least 2 months without steroid use or on a stable dose of steroids for at least 1 month prior to the first dose of MEK162
•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 (average of 3 consecutive readings)
•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.