EUCTR2008-006344-19-FR进行中（未招募）1 期
A Phase II, Double-Blind, Randomised Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination with Dacarbazine Compared with Dacarbazine Alone in First Line Patients with BRAF Mutation Positive Advanced Cutaneous or Unknown Primary Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
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
- •Provision of signed, written and dated informed consent prior to any study specific procedures
- •Male or female, aged 18 years or older
- •Histological or cytological confirmation of advanced cutaneous or unknown primary melanoma
- •WHO performance status 0 1
- •At least one lesion, not previously irradiated, that can be accurately measured at baseline as =10 mm in the longest diameter (LD; except lymph nodes which must have a short axis =15 mm) with CT or MRI, and which is suitable for accurate repeated measurements.
- •Tumour sample confirmed as BRAF mutation positive (Note: sample must be available upon enrolment to ship to the AstraZeneca appointed central laboratory, or mutation status confirmed locally at an AstraZeneca agreed local laboratory using agreed methodology.
- •Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Post menopausal status is defined as:
- •-natural menopause with menses >1 year ago
- •-radiation induced oophorectomy with last menses >1 year ago
- •-chemotherapy-induced menopause with 1 year interval since last menses
- •-serum FSH and LH and plasma oestradiol levels in the postmenopausal range for the institution
- •-bilateral oophorectomy or hysterectomy
- •Serum creatinine clearance >50 ml/min, by either Cockcroft-Gault formula or 24 hour urine collection analysis
- •Patients should be able to swallow AZD6244/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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •Previous randomization of treatment in the present study
- •Having received an investigational drug within the 30 days prior to entry, or have not recovered from side effects of an investigational drug
- •Diagnosis of uveal or mucosal melanoma
- •Any prior Investigational therapy comprising inhibitors of Ras, Raf or MEK
- •Any prior cytotoxic chemotherapy or biochemotherapy for advanced melanoma
- •patients who previously received adjuvant biochemotherapy will be eligible, unless their treatment included temozolomide or dacarbazine
- •Any other investigational non-chemotherapeutic therapy for advanced melanoma, with the exception of prior monotherapy with interleukin-2, cytokines (eg, a interferon or GM-CSF) or vaccine, which are permitted- use of anti-CTLA4 monoclonal antibodies will be allowed in adjuvant settings
- •Any non-systemic therapy (except focal palliative radiotherapy) for advanced melanoma within 30 days of starting study treatment
- •Any unresolved toxicity above CTCAE grade 2 from previous anti-cancer therapy, apart from alopecia
- •Brain metastases or spinal cord compression unless treated and stable off treatment (eg, steroids) for at least 3 months
- •Laboratory values as listed below (from laboratory results at Visit 1):
- •-ANC <1.5x109/L (1,500 per mm3)
- •-Platelets <100x109/L (100,000 per mm3)
- •-Haemoglobin =9.0 g/dL
- •-Serum bilirubin >1.5xULN
- •-AST or ALT >2.5xULN
- •LDH =2xULN (from the Visit 1 laboratory result)
- •Cardiac conditions as follows:
- •-Uncontrolled hypertension (BP=150/95 despite optimal therapy)
- •-Heart failure NYHA Class II or above
- •-Prior or current cardiomyopathy
- •-Baseline LVEF =50%
- •-Atrial fibrillation with heart rate >100 bpm
- •-Unstable ischaemic heart disease (myocardial infarction within 6 months prior to starting treatment, or angina requiring use of nitrates more than once weekly)
- •Major surgery within 4 weeks prior to starting study treatment
- •Hypersensitivity to AZD6244, or dacarbazine or any excipient of these agents
- •Patients with a history of another primary malignancy within 5 years prior to starting study treatment, except adequately treated basal or squamous cell carcinoma of the skin, or carcinoma of the cervix in situ and the disease under study
- •Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diathesis or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- •Refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
- •Female patients who are breast-feeding or patients of reproductive potential who are not employing an effective method of birth control
- •Clinical judgement by the investigator that the patient should not participate in the study.
研究者
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