EUCTR2013-004458-34-DE进行中（未招募）1 期
A Phase I/II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Nintedanib/Vargatef in Combination With Paclitaxel Chemotherapy for Treatment of Patients with BRAF Wildtype Metastatic Melanoma - Nipawilma
niversity of Essen0 个研究点目标入组 126 人开始时间: 2014年8月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
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
- •1. Histologically confirmed, (surgically incurable or unresectable) stage III or IV, BRAF
- •V600 wildtype metastatic cutaneous malignant melanoma.
- •2. Written informed consent
- •3. A minimum of 1 measurable lesion according to RECIST v1.1 criteria.
- •4. ECOG performance status of 0-1.
- •5. Adequate hematologic, renal and liver function as defined by laboratory values
- •performed within 14 days prior to initiation of dosing:
- •Hematologic:
- •o Absolute neutrophil count (ANC) =1.5 x 109/L
- •o Hemoglobin = 9 g/dL (5.6 mmol/L; Subjects may not have had a transfusion
- •within 7 days of screening assessment)
- •o Platelets: = 100 x 109/L
- •o Total bilirubin: = 1.0 x ULN
- •o AST and ALT: = 1.5 x ULN (In the case of liver metastases: 2.5 x ULN)
- •o Serum creatinine: = 1.5 mg/dL (133 µmol/L) or, if greater than 1.5 mg/dL:
- •Calculated creatinine clearance: = 50 mL/min
- •6. Women of childbearing potential (WOCBP) should be using an effective method of
- •contraception (Pearl-Index <1) to avoid pregnancy for at least 6 months after completion
- •of paclitaxel treatment and for at least 3 months after completion of nintedanib/placebo
- •monotherapy as directed by their physician. Women will be considered to be of
- •childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal
- •ligation/salpingectomy, or post-menopausal for at least two years. WOCBP must have a
- •negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units
- •of HCG) up to 28 days prior to commencement of dosing.
- •7. Men should use an effective method of contraception during treatment and for at least 6
- •months after completion of paclitaxel treatment and for at least 3 months after
- •completion of nintedanib/placebo monotherapy as directed by their physician.
- •8. Patients must have recovered from all prior treatment-related toxicities to NCI CTCAE
- •(v4.0) Grade of 0 or 1, except for toxicities not considered a safety risk such as alopecia.
- •9. Male or female, aged 18 years or older
- •10. Life expectancy at least 3 months
- •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 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 63
排除标准
- •1. Prior systemic therapy with taxanes or kinase inhibitors. Any prior therapy for metastatic
- •disease must have been discontinued at least 4 weeks prior to initiation of dosing.
- •2. Major surgery or radiation therapy within 4 weeks of starting the study treatment (minor
- •surgical procedures such as biopsies are allowed, however patients must have
- •recovered).
- •3. Known inherited predisposition to bleeding or thrombosis and therapeutic
- •anticoagulation (except low-dose heparin and/or heparin flush as needed for
- •maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for
- •low-dose therapy with acetylsalicylic acid < 325mg per day)
- •Patients with the following coagulation parameters will be excluded:
- •o International normalised ratio (INR) > 2
- •o Prothrombin time (PT) and partial thromboplastin time (PTT): > 50% of deviation
- •of institutional ULN
- •4. History of clinically significant haemorrhagic or thromboembolic event in the past 6
- •5. NCI CTCAE (V4.0) grade 3 hemorrhage within 4 weeks of starting the study treatment.
- •6. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
- •within 6 months prior to randomization.
- •7. Serious, non-healing wound, ulcer, or bone fracture.
- •8. Known CNS disease.
- •9. Previous Grade 2 or higher sensory neuropathy.
- •10. History of or known spinal cord compression, or carcinomatous meningitis, or evidence
- •of active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment
- •with radiotherapy, symptomatic, requiring treatment with anti-convulsants;
- •dexamethasone therapy will be allowed if administered as stable dose for at least one
- •month before randomization) or leptomeningeal disease on screening CT or MRI scan.
- •11. Any of the following within the 6 months prior to enrolment: myocardial infarction,
- •severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic
- •congestive heart failure, cerebrovascular accident or transient ischemic attack, or
- •pulmonary embolism.
- •12. New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- •13. Ongoing cardiac dysrhythmias of NCI CTCAE Version 4.0 grade = 2.
- •14. Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or
- •diastolic blood pressure > 100 mmHg on antihypertensive medications).
- •15. Symptomatic peripheral vascular disease.
- •16. Proteinuria at screening as demonstrated by urine dipstick for proteinuria = 2+ (patients
- •discovered to have = 2+ proteinuria on dipstick urinalysis at baseline should undergo a
- •24 hour urine collection and must demonstrate = 1g of protein in 24 hours to be eligible).
- •17. Known hypersensitivity reaction to any of the components of study treatment (e.g.
- •contrast media) or other severe acute or chronic medical or psychiatric condition or
- •laboratory abnormality that may increase
研究者
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