CTRI/2012/07/002756已完成3 期
Open-label, multicenter, multi-national, phase III study to assess the safety of RO5185426 in patients with BRAF V600 mutation-positive (identified by the cobas 4800 BRAF V600 Mutation Test) metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 900
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
入选标准
- •Inclusion Criteria:
- •1. Male or female patients >= 16 years of age
- •2. 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
- •3. Patients with either measurable or non-
- •measurable disease(RECIST Version 1.1)
- •4. Patients may or may not have received prior
- •systemic therapy for metastatic melanoma
- •5. Eastern Cooperative Oncology Group (ECOG)
- •performance status (PS) of 0-2
- •6. Patients must have recovered from all side
- •effects of their most recent systemic or
- •local treatment for metastatic melanoma
- •7. 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
- •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 Cockroftâ??Gault formula
- •Aspartate aminotransferase (AST [SGOT]) and
- •alanine aminotransferase (ALT [SGPT]) <= 2.5
- •times ULN (<= 5times ULN if considered due
- •Serum bilirubin <= 1.5 times ULN
- •Alkaline phosphatase <= 2.5 times ULN (<=
- •5times ULN if considered due to tumor)
- •8. 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.
- •9. 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
- 另有 18 项未显示
排除标准
- •1. Evidence of symptomatic CNS lesions as
- •determined by investigator (patients with
- •radiographically stable, asymptomatic lesions
- •previously irradiated or surgically resected
- •are eligible)
- •2. 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
- •3. Concurrent administration of any anti-cancer
- •therapies (e.g. chemotherapy, other targeted
- •therapy, experimental drug, etc) other than
- •those administered in this study
- •4. Known hypersensitivity to RO5185426 or
- •another BRAF inhibitor
- •5. Pregnant or lactating women
- •6. Refractory nausea and vomiting,malabsorption,
- •external biliary shunt, or significant bowel
- •resection that would preclude adequate
- •absorption. Patients must be able to swallow
- •7. 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
- •8. History of congenital long QT syndrome,
- •history or presence of clinically significant
- •ventricular or atrial dysrhythmias >= Grade 2
- •(NCI CTCAE Version 4.0)
- •9. Corrected QT (QTc) interval >= 450 msec at
- •10.Uncontrolled medical illness (such as
- •infection requiring treatment with
- •intravenous (IV) antibiotics)
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