A clinical study evaluating the safety and efficacy of an investigational compound (MEK162) in adult patients with a specific type of advanced cutaneous malignant melanoma
- Conditions
- locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring BRAFV600 or NRAS mutationsMedDRA version: 20.0 Level: PT Classification code 10027480 Term: Metastatic malignant melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-023412-13-DE
- Lead Sponsor
- Array BioPharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 170
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.
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 the 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
10. Patient is deemed by the Investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up) and be within geographical proximity to make the required study visits
11. Negative serum ß-HCG test (female patients of childbearing potential only) within 72 hrs prior to first dose
12. Written informed consent obtained prior to any screening procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85
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.
7. Patients who have received prior systemic anti-cancer treatment within the following time frames:
• Patients who have received cyclical chemotherapy within a period of time that is shorter than the cycle length used for that treatment (e.g., 6 weeks for nitrosourea, mitomycin-C) prior to starting study drugs
• Patients who have received biologic therapy (e.g., antibodies) within 4 weeks prior to starting study drug
• Patients who have been treated with continuous or intermittent small molecule therapeutics within = 5 t1/2 of the agent, or = 4 weeks prior to starting study drug where half life is unknown
• Patients who have received any other investigational agents within a period of time that is less than the cycle length used for that treatment or = 4 weeks (whichever is shorter) prior to starting study drugs
• Treatment with prior radiotherapy within 28 days of the first dose of study drug; however, if the radiation portal covered = 10% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy
8. Patients who have undergone major surgery = 4 weeks prior to starting study drug or who have not recovered from side effects of such procedure
9. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
10. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are:
• women whose sexual orientation precludes intercourse with a male partner
• women whose partners hav
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method