EUCTR2011-000195-34-IE进行中（未招募）1 期
A single arm, open-label, phase II, multicentre study to assess the safety of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma (BCC). - STEVIE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
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. Written, signed informed consent
- •2. Age = 18 years
- •3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2
- •4. For patients with metastatic BCC, histologic confirmation of distant BCC metastasis
- •5. For patients with locally advanced BCC, at least one histologically confirmed lesion 10 mm or more in diameter and written confirmation from a surgical specialist that the tumour is considered inoperable or that surgery is contraindicated. Examples of medical contraindications to surgery include but are not limited to:
- •BCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely
- •Anticipated substantial morbidity and/or deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation)
- •6. For patients with locally advanced BCC, radiotherapy must have been previously administered for locally advanced BCC, unless radiotherapy is contraindicated or inappropriate (e.g., hypersensitivity to radiation due to genetic syndrome such as Gorlin syndrome, limitations because of location of tumour, or cumulative prior radiotherapy dose). For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation
- •7. Patients with Gorlin syndrome may enroll in this study but must meet the criteria for locally advanced or metastatic disease listed above
- •8. Patients with measurable and/or non-measurable disease (as defined by RECIST, v1.1) are allowed
- •9. Adequate organ function, as evidenced by the following laboratory results:
- •Haemoglobin > 8.5 g/dL
- •Granulocyte count = 1000/µL
- •Platelet count = 75,000/µL
- •Aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) = 3 × upper limit of normal (ULN)
- •Total bilirubin = 1.5 × ULN or within 3 × ULN for patients with documented Gilbert syndrome
- •10. Women of childbearing potential must use two methods of acceptable contraception, including one highly effective method and a barrier method, as directed by their physician during treatment and for at least 24 months after completion of study treatment. Highly-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 (e.g., implants, injectables, combined oral contraception, or intra-uterine devices). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence. Periodic abstinence (e.g., calendar, ovulation, symptothermal, and postovulation methods) and withdrawal are not acceptable methods of contraception.
- •11. For male patients with female partners of childbearing potential, agreement to use a condom with spermicide, even after vasectomy, during sexual intercourse with female partners while being treated with vismodegib and for 2 months after completion of study treatment.
- •12. Agreement not to donate blood or blood products during the study and for at least 24 months after discontinuation of vismodegib. Because vismodegib has been detected in seminal fluid, in addition for men, agreement not donate sperm during the study or for at least 2 months after discontinuation of therapy.
- •13. Life expectancy > 12 weeks
- •14. Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included if
排除标准
- •1. Inability or unwillingness to swallow capsules
- •2. Pregnancy or lactation
- •3. Concurrent non–protocol-specified anti-tumour therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy, including participation in an experimental drug study; note that treatment breaks up to 8 weeks for radiation therapy are allowed)
- •4. Completion of most recent anti-tumour therapy less than 21 days prior to initiation of treatment
- •5. Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics
- •6. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk from treatment complications
- •7. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol
- •8. Patients with one of the following rare hereditary conditions: galactose intolerance, primary hypolactasia, or glucose-galactose malabsorption
研究者
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