PER-052-13未知未知
AN OPEN LABEL, PHASE I STUDY TOEVALUATE THE IMPACT OF SEVERE HEPATICIMPAIRMENT ON THE PHARMACOKINETICSAND SAFETY OF VEMURAFENIB IN BRAFV600MUTATION POSITIVE CANCER PATIENTS
适应症
试验速览
- 阶段
- 未知
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
- 年龄范围
- 18 至 100（—）
- 性别
- All
入选标准
- •Disease-Specific Inclusion Criteria:
- •Histologically confirmed BRAFV600 mutation−positive advanced solid malignancy that is
- •metastatic or unresectable and for which standard curative or palliative measures do not
- •exist or are no longer effective.
- •The BRAFV600 mutation−positive status of the underlying malignancy must be established
- •using the cobas® BRAF V600 Mutation Test or a DNA sequencing method (e.g., Sanger)
- •performed in CLIA-certified laboratory or equivalent.
- •Normal or impaired hepatic function. Hepatic function will be classified according to the NCI
- •Organ Dysfunction Working Group criteria:
- •normal hepatic function: total bilirubin ≤ upper limit of normal (ULN) and AST ≤ULN
- •severe hepatic impairment: total bilirubin 3−10 × ULN and AST any value
- •For patients with hepatic impairment: Stable hepatic function for at least 2 weeks
- •(> 14 days) before Day 1. Stable hepatic function is defined as: patients must continue
- •to meet the criteria for severe hepatic impairment defined above (i.e., total bilirubin
- •3−10 ×ULN). In addition, there should be no evidence of acute clinical exacerbation
- •of hepatic disease.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2
- •Patients with a history of recent brain metastases must have completed any radiation
- •therapy (whole brain or gamma knife) at least 4 weeks before Day 1, be without intervening
- •signs of brain lesion progression and not require steroids before starting the protocol
- •(Day 1). Patients with gliomas or known brain metastases who require anticonvulsants
- •must be seizure free for 1 month prior to enrollment.
- •General Inclusion Criteria:
- •Male or female patient age ≥ 18 years
- •Life expectancy ≥ 8 weeks
- •Able to participate and willing to give written informed consent prior to performance of any
- •study-related procedures and to comply with the study protocol
- •Adequate hematologic and renal function, as defined by the following laboratory results
- •obtained within 14 days prior to Day 1:
- •Absolute neutrophil count ≥ 1.5 × 109/L
- •Platelet count ≥ 50 × 109/L
- •Hemoglobin ≥ 9 g/dL
- •Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min on the basis of the
- •Cockcroft-Gault glomerular filtration rate estimation (Cockcroft and Gault 1976):
- •[(140 − age) × (weight in kg) × (0.85 if female)] ÷ [72 × (serum creatinine in mg/dL)]
- •Female patients of childbearing potential and male patients with partners of childbearing
- •potential must agree to always use two adequate methods of contraception including at
- •least one method with a failure rate of < 1% per year during the course of this study and for
- •at least 6 months after completion of study treatment.
- •Female patients of childbearing potential are defined as sexually mature women
- •without prior hysterectomy who have had any evidence of menses in the past
- •In order to be considered not of childbearing potential, amenorrhea for a period of
- •12 months or longer must have occurred in the absence of chemotherapy,
- •anti-estrogen therapy, or ovarian suppression.
- •Effective forms of contraception include surgical sterilization, a reliable barrier
- •method with spermicide, birth control pills/patches, intra-uterine contraceptive device,
排除标准
- •Cancer-Related Exclusion Criteria:
- •Allergy or hypersensitivity to components of the vemurafenib formulation
- •Requirement for immediate or urgent treatment with twice daily vemurafenib and for whom
- •the intermittent schedule of vemurafenib employed during Days 1−26 of this trial is not
- •clinically acceptable.
- •Chemotherapy, biologic therapy, immunotherapy, or radiotherapy within 4 weeks prior to
- •entering the study, or those who have not recovered from AEs because of agents
- •administered more than 4 weeks earlier.
- •Gliomas or known brain metastases that require corticosteroids
- •Cardiac Exclusion Criteria:
- •History of clinically significant cardiac or pulmonary dysfunction, including the following:
- •Current uncontrolled, Grade ≥ 2 hypertension (treated or untreated) or unstable
- •Current Grade ≥ 2 dyspnea or hypoxia or need for supplemental oxygen
- •History of symptomatic congestive heart failure of Grade II through IV (New York
- •Heart Association Class)
- •Serious cardiac arrhythmia requiring treatment, with the exceptions of atrial
- •fibrillation and paroxysmal supraventricular tachycardia
- •History of myocardial infarction within 6 months prior to Day 1
- •History of congenital long QT syndrome or QTc interval > 450 ms at baseline
- •History of an uncorrectable electrolyte disorder affecting serum levels of potassium,
- •calcium, or magnesium
- •General Exclusion Criteria:
- •Major surgical procedure or significant traumatic injury within 4 weeks prior to the first dose
- •of vemurafenib treatment
- •HIV-positive patient requiring antiviral treatment including protease inhibitors (e.g., indinavir,
- •nelfinavir, ritonavir or saquinavir) within 4 weeks before or during study treatment
- •Active infection or chronic infection requiring chronic suppressive antibiotics
- •Pregnancy or breastfeeding at Day 1
- •Active autoimmune disease (e.g., systemic lupus erythematosus, autoimmune vasculitis,
- •inflammatory bowel disease)
- •History of malabsorption or other clinically significant metabolic dysfunction
- •Any other serious concomitant medical condition that, in the opinion of the investigator,
- •would compromise the safety of the patient or compromise the patient’s ability to participate
- •in the study
- •Requirement for a concomitant medication or dietary supplement that is prohibited during
- •Unwillingness or inability to comply with study and follow-up procedures
- •Current, recent (within 28 days prior to Day 1), or planned use of any investigational product
- •outside of this study
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