EUCTR2010-019821-32-GB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 - TRINOVA-1
Amgen Inc.0 个研究点目标入组 919 人开始时间: 2012年2月23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
- 919
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
- •Generally well-controlled blood pressure with systolic blood pressure
- •= 140 mmHg AND diastolic blood pressure = 90 mmHg prior to randomization.
- •The use of anti-hypertensive medications to control hypertension is permitted.
- •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 651
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 268
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 alopecia
- •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
- •Treatment within 30 days prior to randomization with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide
- •General Medical
- •Clinically significant cardiovascular 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
- •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 surgery
- •Minor surgical procedures, except placement of tunneled central venous access device within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor surgical procedure.
- •History of allergic reactions to bacterially-produced proteins
- •Hypersensitivity to paclitaxel or drugs using the vehicle cremo
研究者
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