EUCTR2011-000874-67-IT进行中（未招募）不适用
An open-label, multicenter, single-arm, Phase I dose-escalation withefficacy tail extension study of RO5185426 in pediatric patients withsurgically incurable and unresectable Stage IIIC or Stage IV melanomaharboring BRAFV600 mutations
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
- 入组人数
- 20
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. Patients with histologically confirmed surgically incurable and
- •unresectable stage IIIC or stage IV (AJCC) melanoma. Unresectable
- •stage IIIC disease must have confirmation from a surgical oncologist.
- •2.Patients must have a positive BRAF mutation result determined by a Roche-designated central reference laboratory using the cobas 4800
- •BRAF V600 Mutation Test prior to administration of RO5185426.
- •3.Patients may have newly diagnosed melanoma or have completed and
- •failed prior standard of care regimen (e.g., DTIC, temozolomide, etc.).
- •4.Measurable disease according to RECIST criteria Version 1.1
- •5. Must have a head CT/MRI to evaluate for CNS metastasis within 28
- •days prior to treatment. Patients with radiographically stable,
- •asymptomatic previously treated lesions are eligible provided:
- •-Patient has received prior treatment [including radiation therapy
- •(whole brain radiotherapy is not allowed with the exception of patients
- •who have also had definitive resection or stereotactic therapy of all
- •radiologically detectable parenchymal lesions), stereotactic
- •radiosurgery, surgical resection] to the site(s) of CNS metastatic disease
- •= 3 months prior to starting study treatment
- •-Patient has no requirement for glucocorticoids, and discontinued = 21
- •days prior to starting study treatment
- •- Patient is not taking anticonvulsants (discontinued at least 3 weeks
- •prior to treatment)
- •6.Patients aged = 12 to = 17 years
- •7.Performance Status: Karnofsky (for patients =16 years of age) or
- •Lansky (for patients < 16 years of age) score = 60
- •8.Patients must have recovered from effects of any major surgery or
- •significant traumatic injury at least 14 days prior to administration of the
- •first dose of study treatment.
- •9.Life expectancy > 3 months.
- •10. Adequate hematologic, renal and liver function as defined by
- •laboratory values performed within 28 days prior to initiation of dosing.
- •11.Completed baseline skin exam by a dermatologist for cutaneous
- •squamous cell carcinoma. Exam must be negative or if, suspected
- •cutaneous SCC lesions are identified they must be excised, and there
- •must be adequate wound healing prior to study treatment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •2.History of or known spinal cord compression, or carcinomatous
- •meningitis.
- •3.Negative result for BRAF mutation as determined using the Roche
- •cobas 4800 BRAF V600 Mutation Test
- •4.Anticipated or ongoing administration of anti-cancer therapies other
- •than those administered in this study.
- •5.Patients with a previous malignancy within the past 5 years are
- •excluded except for patients with basal or squamous cell carcinoma
- •(SCC) of the skin, melanoma in-situ, and carcinoma in-situ of the cervix.
- •6.Patients who have been previously treated with a selective/specific
- •BRAF or MEK inhibitor (previous treatment with sorafenib is allowed).
- •7.Patients who have had any previous treatment with study drug
- •(RO5185426) or participated in a clinical trial that includes RO5185426.
- •8.QTc >450 msec on screening or baseline ECG or history of congential
- •long QT syndrome.
- •9.NCI-CTCAE Version 4.0 grade 3 hemorrhage within 4 weeks of starting
- •the study treatment.
- •10.Any of the following within the 6 months prior to study drug
- •administration: myocardial infarction, severe/unstable angina,
- •coronary/peripheral artery bypass graft, symptomatic congestive heart
- •failure, serious cardiac arrhythmia requiring medication, uncontrolled
- •hypertension, cerebrovascular accident or transient ischemic attack, or
- •symptomatic pulmonary embolism.
- •11.Known clinically significant active infection at the time of study
- •treatment start, at the time of screening or within 14 days of study drug start.
- •12.History of allogeneic bone marrow transplantation or organ
- •transplantation.
- •of the investigator would make the patient inappropriate for entry into
- •this study.
- •13.Known HIV positivity or AIDS-related illness, or active HBV, and
- •active HCV.
研究者
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