EUCTR2010-019821-32-GR进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Amgen Inc.0 个研究点目标入组 900 人开始时间: 2010年11月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
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
- •Disease Related
- •Histologically or cytologically documented invasive epithelial ovarian cancer, primary
- •peritoneal cancer, or fallopian tube cancer
- •- Subjects with pseudomyxoma , mesothelioma, unknown primary tumor, sarcoma,
- •or neuroendocrine histology are excluded
- •- Subjects with borderline ovarian cancer, ie, subjects with low malignant potential
- •tumors, are excluded
- •- Subjects with clear cell or mucinous histology are excluded
- •Subjects must have undergone surgery for ovarian cancer, primary peritoneal
- •cancer, or fallopian tube cancer including at least a unilateral oophorectomy
- •Radiographically documented disease progression either on or following the last
- •dose of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal
- •cancer, or fallopian tube cancer
- •Radiologically evaluable disease per RECIST 1.1 with modifications
- •- There must be radiographically visible tumor
- •- Subjects with only ascites or pleural effusion are excluded
- •Subjects must have had one prior platinum-based chemotherapeutic regimen for
- •management of primary disease containing carboplatin, cisplatin, or another
- •organoplatinum compound. This initial treatment may have included intraperitoneal
- •therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy
- •administered after surgical or non-surgical assessment.
- •- Subjects are allowed to receive, but are not required to receive, two additional
- •cytotoxic regimens for management of recurrent or persistent disease.
- •Demographic
- •Female 18 years of age or older at the time the written informed consent is obtained
- •Subjects of child-bearing potential who have not undergone a bilateral
- •salpingo-oophorectomy and are sexually active must consent to use an accepted
- •and effective non-hormonal method of contraception [ie, double barrier method (eg,
- •condom plus diaphragm)] from signing the informed consent through 6 months after
- •last dose of study drug
- •GOG Performance Status of 0 or 1 (see Appendix H)
- •Life expectancy = 3 months (per investigator opinion)
- •Subject plans to begin protocol-directed therapy within 7 days from randomization
- •Adequate organ and hematological function as evidenced by the following laboratory
- •studies prior to randomization:
- •- Hematological function (see protocol for definition)
- •- Renal function (see protocol for definition)
- •- PTT or aPTT = 1.5 x ULN per institutional laboratory range and INR = 1.5
- •- Hepatic function (see protocol for definition)
- •- Nutritional (see protocol for definition)
- •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
- •Disease Related
- •Subjects who have received more than 3 previous regimens of anti-cancer therapy
- •for epithelial ovarian, primary peritoneal or fallopian tube cancers
- •Subjects who have received paclitaxel as consolidation therapy, maintenance, or
- •monotherapy are excluded
- •Subjects with primary platinum-refractory disease
- •- Subjects with recurrence or progression during the first 6 cycles or < 6 months
- •after the beginning of the first-line platinum-based chemotherapy are excluded
- •Subjects with platinum-free interval (PFI) > 12 months from their last platinum-based therapy
- •Radiotherapy = 14 days prior to randomization. Subjects must have recovered from
- •all radiotherapy-related toxicities
- •- If all sites of disease have been irradiated, documented progression must have
- •occurred in at least 1 site of disease subsequent to the radiation therapy
- •Previous abdominal or pelvic radiotherapy
- •History of arterial or venous thromboembolism within 12 months prior to
- •randomization
- •History of clinically significant bleeding within 6 months prior to randomization
- •History of central nervous system metastasis
- •Medications
- •Has not yet completed a 21 day washout period prior to randomization for any
- •previous anti-cancer systemic therapies (30 days for prior bevacizumab)
- •Enrolled in or has not yet completed at least 30 days (prior to randomization) since
- •ending other investigational device or drug, or currently receiving other
- •investigational treatments
- •Unresolved toxicities from prior systemic therapy that are Common Terminology
- •Criteria for Adverse Events (CTCAE) Version 3.0 = Grade 2 in severity except
- •Known active or ongoing infection (except uncomplicated urinary tract infection [UTI]) within 14 days prior to randomization
- •Currently or previously treated with AMG 386, or other molecules that inhibit the
- •angiopoietins or Tie2 receptor
- •Current or treatment within 30 days prior to randomization with immune modulators such as systemic cyclosporine or tacrolimus
- •General Medical
- •Clinically significant cardiac disease within 12 months prior to randomization,
- •including myocardial infarction, unstable angina, grade 2 or greater peripheral
- •vascular disease, cerebrovascular accident, transient ischemic attack, congestive
- •heart failure, or arrhythmias not controlled by outpatient medication or placement of
- •percutaneous transluminal coronary angioplasty/stent
- •Uncontrolled hypertension as defined as diastolic blood pressure > 90 mmHg OR
- •systolic blood pressure > 140 mmHg. The use of anti-hypertensive medications to
- •control hypertension is permitted.
- •Subjects with a history of prior malignancy, except:
- •- Malignancy treated with curative intent and with no known active disease present
- •for = 3 years prior to randomization and felt to be at low risk for recurrence by
- •treating physician
- •- Adequately treated non-melanomatous skin cancer or lentigo maligna without
- •evidence of disease
- •- Adequately treated cervical carcinoma in situ without evidence of disease
- •Prior myeloablative high-dose chemotherapy with allogeneic or autologous stem cell
- •(or bone marrow) transplant
- •Major surgery within 28 days prior to randomization or still recovering from prior
- •Minor surgical procedures, including placement of tunneled central venous access
- 另有 4 项未显示
研究者
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