NL-OMON44683招募中3 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
Astra Zeneca0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
排除标准
- •Patients should not enter the study if any of the following exclusion criteria are fulfilled:;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 been previously treated with a systemic anti-cancer therapy. Patients can have prior intra-hepatic 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 halflives 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 non-systemic 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
研究者
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