EUCTR2013-003545-41-ES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) - SUMIT
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 in the study.
研究者
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