A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL EVALUATING THE EFFICACY AND SAFETY OF 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 100 人开始时间: 2008年10月29日最近更新: 2012年3月19日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Genentech, Inc.
入组人数: 100

研究概览入排标准研究者记录与标识符相似试验

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: Female

入选标准

•Patients must meet the following inclusion criteria to be eligible for study entry:
•Age = 18 years
•Histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal
•carcinoma, or fallopian tube carcinoma
•Must be in second or third complete remission, have received chemotherapy
•(platinum-based and/or non-platinum-based) for recurrent disease, and have
•achieved a complete remission after their most recent chemotherapy regimen
•Complete remission is defined as no symptoms suggestive of persistent
•cancer, CT scan of the chest/abdomen/pelvis without evidence of ovarian
•cancer within 4 weeks of randomization, and normal CA-125 (measured
•within 2 weeks of randomization) following completion of prior chemotherapy.
•The study investigator should confirm the status of disease remission by CT scan
•before patient enrollment.
•If patient has lymphadenopathy by CT scan and the investigator thinks that it is
•unlikely due to ovarian cancer, this patient is considered eligible. If indicated,
•a confirmatory biopsy should be performed.
•Patients must have completed their most recent dose of cytotoxic
•chemotherapy regimen (platinum-based or non-platinum based) no less than
•3 weeks and no more than 14 weeks prior to randomization.
•Archival tissue must be available and requested.
•The tissue must consist of 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. Archival
•tissues are to be sent as soon as possible.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•(see Appendix D)
•Adequate hematopoietic capacity, as defined by the following:
•Hemoglobin > 8.5 g/dL, not transfusion-dependent
•Granulocyte count = 1200/µL
•Platelets = 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 × ULN or within 3 × ULN for patients with Gilbert’s disease
•Adequate renal function, as defined by the following:
•Serum creatinine = 2.0 mg/dL or calculated creatinine clearance > 50 mL/minute
•Negative serum or urine pregnancy test on Day 1
•For women of childbearing potential: Use of two effective methods of barrier
•contraception, including one barrier method (See Appendix C for acceptable
•and unacceptable methods of contraception.)
•Signed informed consent
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•Patients who meet any of the following criteria will be excluded from study entry:
•Pregnancy or lactation
•For women of childbearing potential: use of two effective methods of
•barrier contraception, including one barrier method, during the study and
•for 12 months after discontinuing study drug (see Appendix C for acceptable
•and unacceptable methods of contraception).
•Patients whose ovarian cancer is in first remission
•Patients must not have experienced more than two prior recurrences
•Concurrent non-protocol-specified anti-tumor therapy, either approved or
•unapproved (e.g., chemotherapy, hormonal therapy, other targeted therapy,
•radiation therapy, surgery, herbal therapy). Hormonal replacement therapies for
•treatment of postmenopausal symptoms do not exclude patients from this study.
•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
•a negligible risk for metastasis or death, such as adequately treated BCC or
•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 IV antibiotics
•Life expectancy < 12 weeks
•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 render the patient at high
•risk from treatment complications.

研究者

发起方

Genentech, Inc.

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