EUCTR2008-004945-27-GB进行中（未招募）不适用
A PIVOTAL PHASE II, MULTICENTER, SINGLE ARM, TWO-COHORT TRIAL EVALUATING THE EFFICACY AND SAFETY OF GDC-0449 IN PATIENTS WITH ADVANCED BASAL CELL CARCINOMA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •Signed informed consents
- •Men and women age = 18 years
- •ECOG performance status 0, 1, or 2
- •For patients with mBCC, histologic confirmation of distant BCC metastasis (e.g., lung, liver, lymph nodes, or bone), with metastatic disease that is RECIST measurable using CT or MRI
- •For patients with locally advanced BCC, at least one histologically confirmed lesion = 10 mm in the longest diameter that is considered to be inoperable or to have a medical contraindication to surgery, in the opinion of a Mohs dermatologic surgeon, head and neck surgeon, or plastic surgeon
- •For patients with locally advanced BCC, radiotherapy must have been
- •previously administered for their 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 tumor, or cumulative prior radiotherapy dose). For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.
- •Patients with nevoid BCC syndrome (Gorlin syndrome) may enroll in this study but must meet the criteria for locally advanced or metastatic disease listed above.
- •For patients with locally advanced BCC, willingness to consent to biopsy of tumor(s) at baseline and during the study, as mandated by the protocol
- •For all patients, representative tumor specimens in paraffin blocks (preferred)or at least 15 unstained slides, with an associated pathology report, obtained at any time prior to entry of study
- •Adequate hematopoietic capacity, as defined by the following:
- •Hemoglobin > 8.5 g/dL and not transfusion dependent
- •Granulocyte count = 1000/µL
- •Platelet count = 75,000/µL
- •Adequate hepatic function, as defined by the following:
- •AST and ALT = 3 × the upper limit of normal (ULN)
- •Total bilirubin = 1.5 × the ULN or within 3 × the ULN for patients with
- •Gilbert disease
- •For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 7 months after discontinuation of vismodegib
- •For men with female partners of childbearing potential, agreement to use a condom, and to advise their female partner to use an additional method of contraception during the study and for 7 months after discontinuation of vismodegib)
- •Agreement not to donate blood or blood products during the study and for 7 months after discontinuation of GDC-0449; for male patients, agreement not to donate sperm during the study and for 2 months after discontinuation of vismodegib
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Inability or unwillingness to swallow capsules
- •Prior treatment with Vismodegib or other antagonists of the Hh pathway
- •Pregnancy or lactation See Inclusion Criteria for women of childbearing potential and men with female partners of childbearing potential. Patients who are unable or are unwilling to adhere to the required contraceptive methods are excluded from the study.
- •Life expectancy of < 12 weeks
- •Patients with superficial multifocal BCC who may be considered unresectable due to breadth of involvement
- •Concurrent non–protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, topical therapy such as 5-fluorouracil or imiquimod, radiation therapy, or photodynamic therapy). For patients with multiple cutaneous BCCs at baseline that are not designated by the investigator as target lesions, treatment of these non-target BCCs with surgery may be permitted but must be discussed with the Medical Monitor prior to any surgical procedure.
- •For patients with locally advanced BCC whose target lesion(s) is/are inoperable at baseline but is/are later deemed potentially operable because of tumor response to vismodegib, surgery with curative intent may be permitted but must be discussed with the Medical Monitor prior to any surgical procedure.
- •Recent (within 4 weeks of Day 1), current, or planned participation in an experimental drug study
- •History of other malignancies within 3 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix
- •Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics
- •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 renders the patient at high risk from treatment complications
研究者
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