EUCTR2015-001731-20-BE进行中（未招募）1 期
A SINGLE ARM, OPEN LABEL, PHASE II, MULTICENTER STUDY TO ASSESS THE DETECTION OF THE BRAF V600 MUTATION ON cfDNA FROM PLASMA IN PATIENTS WITH ADVANCED 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
- 208
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
入选标准
- •General inclusion criteria:
- •- Male or female patient aged >= 18 years
- •- Eastern Coorperative Oncology Group (ECOG) Performance Status of 0-2
- •- Adequate hematologic and end organ function (renal and liver)
- •- Negative serum pregnancy test prior to commencement of dosing in women of childbearing potential
- •- Absence of any psychological, familial, sociological, or geographical condition that potentially hampers compliance with the study protocol and treatment regimen and follow-up after treatment discontinuation schedule; those conditions should be discussed with the patient before trial entry
- •- Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use 2 effective forms of contraception during the course of this study and for at least 6 months after completion of study therapy
- •a. Females of childbearing potential are defined as sexually mature women without prior oophorectomy or hysterectomy who have had menses within the last 12 months.
- •b. Females are not considered to be of childbearing potential if amenorrheic for > 12 months but < 2 years and follicle-stimulating hormone (FSH) level > 40 IU/L.
- •c. Effective forms of contraception include surgical sterilization, a reliable barrier, method with spermicide, birth control pills, or contraceptive hormone implants. Please note that potential interactions between vemurafenib and hormonal contraceptives may decrease the effectiveness of hormonal contraceptives.
- •d. d.Male patients who are surgically sterilized are required to use barrier methods of contraception
- •Disease-specific Inclusion Criteria:
- •- Patients with histologically confirmed cutaneous melanoma, either unresectable Stage IIIc or Stage IV metastatic melanoma, as defined by AJCC 7th edition
- •- Documentation of BRAF V600 mutation-positive status in melanoma tumor tissue using a validated tissue test
- •- Patients with measurable or non-measurable disease (Response Evaluation Criteria in Solid Tumors version 1.1)
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 58
排除标准
- •Cancer-Related Exclusion Criteria:
- •1. History of prior RAF or mitogen-activated protein kinase (MEK) pathway inhibitor treatment
- •2. Treatment related:
- •a.Palliative radiotherapy within 14 days prior to the first dose of study treatment
- •b. Use of prior chemotherapy or immunotherapy (incl. treatment with an anti-PD1, or anti-PDL1 or anti-CTLA-4 monoclonal antibody) within 4 weeks before first study drug administration
- •Exclusion Criteria Based on Organ Function:
- •- Ocular: Evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/ central serous chorioretinopathy, retinal vein occlusion, or neovascular macular degeneration
- •- Patients will be excluded if they have one of the following conditions: a) Uncontrolled glaucoma with intra-ocular pressures >= 21 mmHg b) Uncontrolled hypercholesterolemia >= Grade 2 c) Hypertriglyceridemia >= Grade 2 d) Hyperglycemia >= Grade 2
- •- Cardiac: History of clinically significant cardiac dysfunction
- •General exclusion criteria:
- •- Current severe, uncontrolled systemic disease
- •- Major surgery or traumatic injury within 14 days prior to first dose of study treatment
- •- History of malabsorption or other condition that would interfere with absorption of study drugs
- •- the following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment:
- •a) St. John’s wort or hyperforin (potent CYP3A4 enzyme inducer)
- •b) Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
研究者
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