EUCTR2013-003545-41-DE进行中（未招募）1 期
A Randomised, Double-Blind Study to Assess the Efficacy of Selumetinib (AZD6244, Hyd-Sulfate) in Combination with Dacarbazine Compared with Placebo in Combination with Dacarbazine as First Systemic Therapy in Patients with Metastatic Uveal Melanoma (SUMIT)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 128
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
- •1.Clinical diagnosis of metastatic uveal melanoma
- •2.Written consent from female or male patients aged 18 years or older
- •3.Histological or cytological confirmation of melanoma who are suitable for treatment with dacarbazine chemotherapy
- •4.At least one lesion that can be accurately measured at baseline as =10 mm in the longest diameter (except lymph nodes which must have short axis =15 mm) with CT or MRI and which is suitable for accurate repeated measurements
- •- ECOG Performance Status 0-1
- •- Life expectancy >12 weeks
- •- Normal organ and marrow function
- •5.Patients should be able to swallow selumetinib/placebo capsules
- •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 113
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •2.Previous randomisation in the present study
- •3.Patients cannot have previously been treated with a systemic anti-cancer therapy. Patients can have had prior intra-hepatic therapy or non-systemic therapy
- •4.Having received any of the following within the specified timeframe:
- •-Any prior systemic anti-cancer therapy for the treatment of this current diagnosis
- •-An investigational drug within 30 days of starting treatment or within five half-lives of the compound (whichever is the most appropriate is at the discretion of the Investigator), or have not recovered from side effects of an investigational drug
- •-Any anti-cancer therapy which has not been cleared from the body by the time of starting study treatment
- •-Radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment
- •-Major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) which would prevent administration of study treatment
- •-Any prior investigational therapy comprising inhibitors of RAS, RAF or MEK at any time
- •-Previous treatment with dacarbazine.
- •5.Any unresolved toxicity >CTCAE grade 2 from previous anti-cancer therapy, excluding alopecia
- •6.History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib or dacarbazine
- •7.Symptomatic brain metastases or spinal cord compression (patients must be treated and stable off steroids and anti-convulsants for at least 1 month prior to entry into the study
- •8.Cardiac conditions as follows:
- •-Uncontrolled hypertension (BP =150/95 mmHg despite medical therapy)
- •-Acute coronary syndrome within 6 months prior to starting treatment
- •-Uncontrolled Angina - Canadian Cardiovascular Society grade II-IV despite medical therapy,
- •-Symptomatic heart failure (New York Heart Association [NYHA] Class II-IV,
- •-Prior or current cardiomyopathy
- •-Baseline LVEF below the LLN (defined for this protocol as <55% on echocardiography or institution’s LLN for MUGA)
- •-Severe valvular heart disease
- •-Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest
- •-QTcF >450 ms or other factors that increase the risk of QTc prolongation
- •9.Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- •10.Refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
- •11.History of another primary malignancy within 5 years prior to starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study
- •12.Ophthalmologic conditions:
- •- Current or past history of retinal pigment epithelial detachment (RPED)/central serous retinopathy
- •- Current or past history of retinal vein occlusion
- •- IOP >21 mmHg or uncontrolled glaucoma (irrespective of IOP)
- •13.Female patients who are breast-feeding a child
- •and male or female patients of reproductive potential who are not employing an effective method of birth control
- •14. Judgement by the Investigator that the patient should not participate i
研究者
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