EUCTR2012-005776-34-ES进行中（未招募）1 期
A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE II TRIAL EVALUATING THE SAFETY AND ACTIVITY OF DNIB0600A COMPARED TO PEGYLATED LIPOSOMAL DOXORUBICIN ADMINISTERED INTRAVENOUSLY TO PATIENTS WITH PLATINUM-RESISTANT OVARIAN CANCER.
Roche Farma, S.A en nombre de Genentech, Inc.0 个研究点目标入组 92 人开始时间: 2014年8月11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
- 92
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
- •? Signed informed consent form
- •? Age ? 18 years
- •? Life expectancy of at least 12 weeks
- •? Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •? Histological documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding carcinosarcoma histology)
- •? Availability and willingness to provide an adequate archival sample of tumor (paraffin tissue block or at least 15 unstained slides); if an archival tissue specimen is not available and a new tissue specimen is collected for diagnostic purposes for patient care, then fresh tissue may be submitted
- •? Advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 6 months after the most recent treatment with a platinum-containing chemotherapy regimen and for whom pegylated liposomal doxorubicin (PLD) is appropriate
- •? Measurable disease with at least one lesion that can be accurately measured in at least one dimension (longest dimension recorded ? 2.0 cm using conventional techniques or ? 1.0 cm on spiral computed tomography [CT] scan) per RECIST v1.1 criteria
- •? No more than one prior cytotoxic chemotherapy regimen for the treatment of PROC and no more than two total regimens (defined as any therapy [approved or investigational] with intent to treat the ovarian cancer)
- •? Absolute neutrophil count ? 1500/?L, hemoglobin ? 9 g/dL, and platelet count ? 100,000/?L
- •? Total bilirubin ? 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 ×ULN
- •? Serum creatinine ? 2.0 mg/dL
- •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 92
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, within 4 weeks prior to Day 1
- •? Palliative radiation within 2 weeks prior to Day 1
- •? Prior anthracycline therapy, including prior treatment with pegylated liposomal doxorubicin (PLD) (e.g., Doxil, Caelyx,? Prior treatment with NaPi2b or SCL34A2 targeted therapy
- •? Major surgical procedure within 4 weeks prior to Day 1
- •? Current Grade > 1 toxicity (except alopecia and anorexia) from prior therapy or Grade > 1 neuropathy from any cause
- •? Left ventricular ejection fraction (LVEF) defined by MUGA/ECHO below the institutional lower limit of normal (LLN)
- •? Evidence of significant, uncontrolled, concomitant disease which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, congestive heart failure, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease, history of bronchospasm, or any ongoing requirement for supplemental oxygen)
研究者
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