EUCTR2010-023412-13-NL进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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 have been sterilized by vasectomy or other means
- •using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs); periodic abstinence (e.g. calendar, ov
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