NCT00954642已完成1 期
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Incidence and nature of dose-limiting toxicities (DLTs)
研究概览
简要总结
This is a Phase Ib, open-label, dose-escalation study of MNRP1685A given by intravenous (IV) infusion as therapy for locally advanced or metastatic solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adequate hematologic and end organ function
- •Evaluable disease or measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST)
- •Agreement to use an effective form of contraception for the duration of the study
- •Inclusion Criteria Unique to Arm A:
- •Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior regimen
- •Inclusion Criteria Unique to Arm B:
- •Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy; a maximum of two prior chemotherapy regimens is allowed
排除标准
- •Any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks or 5 half-lives (for systemic agents), whichever is shorter, prior to initiation of study treatment with the following exceptions: hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists or antagonists for prostate cancer; herbal therapy > 1 week prior to Day 1; hormone-replacement therapy or oral contraceptives; palliative radiotherapy for bone metastases > 2 weeks prior to Day 1
- •Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytics, or a filter of the inferior vena cava
- •Leptomeningeal disease as a manifestation of the current malignancy
- •Active infection requiring IV antibiotics
- •Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs, inhaled corticosteroids, or the equivalent of ≤ 10 mg/day prednisone
- •Bisphosphonate therapy for symptomatic hypercalcemia
- •Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
- •Known human immunodeficiency virus (HIV) infection
- •Known primary CNS malignancy, or untreated or active CNS metastases
- •Pregnancy, lactation or breast feeding
- •Inadequately controlled hypertension
- •History of hypertensive crisis or hypertensive encephalopathy
- •History of myocardial infarction or unstable angina within 6 months prior to Day 1
- •New York Heart Association (NYHA) Class II or greater CHF
- •History of stroke or transient ischemic attack (TIA) within 6 months prior to Day 1
- •Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
- •History of hemoptysis within 1 month prior to Day 1
- •Evidence of bleeding diathesis or significant coagulopathy in the absence of stable therapeutic anticoagulation
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study
- •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
- •History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to Day 1
- •Clinical signs or symptoms of gastrointestinal obstruction or requirement for parenteral hydration, parenteral nutrition, or tube feeding because of an active gastrointestinal condition
- •Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- •Serious, non-healing wound, active gastrointestinal ulcer, or untreated bone fracture
- •Intrathoracic lung carcinoma of squamous cell histology
- •Grade ≥ 2 sensory neuropathy
- •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- •Known hypersensitivity to recombinant human antibodies
- •Exclusion Criterion Unique to Arm B:
- •Known significant hypersensitivity to paclitaxel or other drugs using the vehicle cremophor
研究组 & 干预措施
B
Experimental
干预措施: MNRP1685A (Drug)
B
Experimental
干预措施: paclitaxel (Drug)
A
Experimental
干预措施: bevacizumab (Drug)
A
Experimental
干预措施: MNRP1685A (Drug)
B
Experimental
干预措施: bevacizumab (Drug)
结局指标
主要结局
Incidence and nature of dose-limiting toxicities (DLTs)
时间窗: Through study completion or early study discontinuation
次要结局
- Pharmacokinetic (PK) parameters of MNRP1685A and bevacizumab, when appropriate, as data allow (total exposure, maximum and minimum serum concentration, clearance, and volume of distribution)(Through study completion or early study discontinuation)
研究者
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