EUCTR2010-023526-21-IE进行中（未招募）1 期
An open-label, multicenter study to assess the safety of RO5185426 in patients with metastatic melanoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,300
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
- •- Male or female patients =16 years of age
- •- Patients with histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with documented BRAF V600 mutation determined by the cobas® 4800 BRAF V600 Mutation Test prior to
- •administration of RO5185426. Unresectable stage IIIC disease must have confirmation from a surgical oncologist
- •- Patients with either measurable or non-measurable disease (RECIST Version 1.1)
- •- Patients may or may not have received prior systemic therapy for metastatic melanoma
- •- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
- •- Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma
- •- Adequate hematologic, renal and liver function as defined by the following laboratory values performed within 7 days prior to first dose of RO5185426:
- •Absolute neutrophil count (ANC) = 1.5 x 109/L
- •Platelet count = 100 x 109/L
- •Hemoglobin = 9 g/dL
- •Serum creatinine = 1.5 times upper limit of normal (ULN) or creatine clearance (CrCl) > 50 mL/hr by Cockroft–Gault formula
- •Aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) = 2.5 times ULN (= 5 times ULN if considered due to tumour)
- •Serum bilirubin = 1.5 times ULN
- •Alkaline phosphatase = 2.5 times ULN (= 5 times ULN if considered due to tumour)
- •- Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for = 1 year
- •- Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician. Effective methods of contraception are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance.[Periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.]
- •- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before trial entry
- •- Signed informed consent must be obtained prior to performing any study-related procedures (including tumour testing for the V600 BRAF mutation)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 3
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2381
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 914
排除标准
- •- Evidence of symptomatic CNS lesions as determined by investigator, use of steroids or anti-seizure medications for the treatment of brain metastases prior to the first administration of RO5185426. Patients with asymptomatic lesions previously irradiated or surgically resected that are radiologically stable are eligible. Patients with incidentally found brain metastasis that are asymptomatic and for which no treatment is planned are also eligible
- •- Patients with a previous malignancy (other than melanoma) within the past 2 years are excluded except patients with treated and controlled basal or squamous cell carcinoma (SCC) of the skin or carcinoma in-situ of the cervix. Isolated
- •elevation in prostate-specific antigen in absence of
- •radiographic evidence of metastatic prostate cancer is allowed
- •- Concurrent administration of any anti-cancer therapies (e.g. chemotherapy, other targeted therapy, experimental drug, etc) other than those administered in this study
- •- Known hypersensitivity to RO5185426 or another BRAF inhibitor
- •- Pregnant or lactating women
- •- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption. Patients must be able to swallow tablets
- •- Any of the following within the 6 months prior to first RO5185426 administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, hypertension not adequately controlled by current medications
- •- History of congenital long QT syndrome, history or presence of clinically significant ventricular or atrial dysrhythmias = Grade 2 (NCI CTCAE Version 4.0)
- •- Corrected QT (QTc) interval = 450 msec at baseline
- •- Uncontrolled medical illness (such as infection requiring treatment with intravenous (IV) antibiotics)
- •- Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or RO5185426 administration, or may interfere with the interpretation of study results, which in the judgment of the investigator would
- •make the patient inappropriate for entry into this study
- •- Unwillingness to practice effective birth control
- •- Inability to comply with other requirements of the protocol
研究者
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