A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission

GENENTECH, INC.,0 个研究点目标入组 0 人开始时间: 2008年11月13日最近更新: 2023年9月4日

适应症

试验速览

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•Age> 18 years
•Histological diagnoses of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma
•They must be in second or third complete remission, have received chemotherapy (platinum-based and / or non-platinum-based) for recurrent disease, and have achieved full remission after the most recent chemotherapy regimen
•Patients must have completed their most recent cytotoxic chemotherapy regimens (platinum-based and / or non-platinum-based) no less than 3 weeks and no more than 12 weeks before screening.
•Preserved tissue should be available and requested.
•Performance status O or 1 by the Eastern Cooperative Oncology Group (ECOG)
•Adequate hematopoietic capacity, defined as follows: Hemoglobin> 8.5 g / dL, non-transfusion dependent, Granulocyte count> 1200 / uL, Platelets> 75,000 / uL
•Adequate liver function, defined as follows: AST and ALT <3x the upper limit of normal (ULN), Total bilirubin <1.5x ULN or within 3x ULN for patients with Gilbert´s disease
•Adequate renal function, defined by the following: Serum creatinine <2.0 mg / dL or measured creatinine clearance> 50 mL / minute
•Negative pregnancy test on Day 1
•For women with pregnancy potential: Use of two effective barrier contraception methods, including a barrier method
•Signed informed consent

•Pregnancy or breastfeeding. For women with pregnancy potential: Use of two effective methods of barrier contraception, including a barrier method, during the study and for 12 months after discontinuation of the drug under study (see Annex 0 for unacceptable contraception methods).
•Patients whose ovarian cancer is in first remission
•Patients should not have experienced more than two previous disease recurrences
•Anti-tumor therapy not specified by concurrent protocol, whether approved or not approved (for example, chemotherapy, hormonal therapy, other specified therapy, radiotherapy, surgery, herbal therapy)
•Current, recent (within 4 weeks of Day 1), or planned participation in an experimental drug study while enrolled in this study
•History of other malignancies within 3 years of Day 1, except for tumors with an insignificant risk for metastases or death, such as properly treated BBC or squamous cell carcinoma of the skin; ductal carcinoma in situ of the breast; or carcinoma in situ of the cervix
•Uncontrolled drug disease such as infections that require IV antibiotics
•Life expectancy <12 weeks
•History of another disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that indicates reasonable suspicion of a disease or condition that contraindicates the use of a drug under investigation or that may affect the interpretation of study results or put to the patient at high risk of treatment complications.

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