NCT02157831已完成1 期
Redosing With CP-870,893 in Patients With Clinical Benefit After a Single Infusion of CP-870,893 From A Phase I, Open-Label, Dose-Escalation Study of CP-870,893 in Patients With Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
Patients who had clinical benefit following a single infusion of CP-870, 893 on Protocol UPCC 10903 will receive a single repeated infusion of CP-870,893 at the same dose given on UPCC 10903 intravenously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
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
- •Clinical benefit, including stable disease, partial response, or complete response, without a dose-limiting toxicity after a single infusion of CP-870,893; however, patients who experienced transient, not serious, and fully reversible grade 1-3 increases in ALT or AST after one dose of CP-870,893 may, if otherwise eligible, receive a second dose on this protocol.
- •Age at least 18 years old;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1;
- •Adequate bone marrow function documented within 2 weeks prior to treatment, defined as:
- •White blood cell (WBC) count >3000 cells/μL without growth factor support;
- •Absolute neutrophil count (ANC) ≥1500/μL without growth factor support;
- •Platelets >100,000/μL without growth factor support; and
- •Hemoglobin ≥10 g/dL.
- •Adequate renal and hepatic function documented within 2 weeks prior to treatment, defined as:
- •Total bilirubin <1.5 times the upper limit of normal (ULN);
- •Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <2.5 × ULN;
- •Creatinine clearance (CLcr, measured or calculated) >80 mL/min; and
- •Life expectancy of at least 12 weeks;
- •Signed written informed consent.
排除标准
- •Concurrent treatment with any anticancer agent;
- •History of autoimmune disorder, including pemphigus vulgaris, systemic mastocytosis, systemic lupus erythamatosus, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen's syndrome, vasculitis/arteritis, Behcet's syndrome, inflammatory bowel disease, autoimmune thyroiditis, multiple sclerosis, or other chronic inflammatory disease;
- •Treatment with any other cancer therapy from the time of the first dose of CP-870,893, except as noted in Section 4.4; 1 Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0, DCTD, NCI, NIH, DHHS. 31 Mar 2003 (http://ctep.cancer.gov).
- •History of congestive heart failure, stroke, or myocardial infarction;
- •Hereditary or acquired coagulopathies (e.g. hemophilia, von Willebrand's disease, cancer-associated DIC);
- •Brain metastases.
- •Patient having reproductive potential who is not using an effective method of birth control or who is pregnant or breastfeeding or has a positive (urine or serum) pregnancy test at baseline;
- •Known sensitivity to immunomodulating agents or monoclonal antibodies;
- •Alcohol abuse or illicit drug use within 12 months of enrollment;
- •History of serum creatinine ≥2 mg/dL for any duration and for any reason;
- •Urine dipstick 1+ or more positive for blood (other than menstruating females) or 2+ or more positive for protein;
- •Positive HAHA antibody titer in response to treatment with first dose of CP-870,893 (as determined by Pfizer)
- •Clinically significant presence of granular or cellular casts in centrifuged urine sediment;
- •Renal carcinoma or renal metastases;
- •Partial or complete nephrectomy;
- •History of dialysis (peritoneal or hemodialysis);
- •Prior treatment with Amphotericin B or cisplatin;
- •History of insulin-dependent diabetes for greater than 5 years;
- •Concomitant treatment with systemic corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline;
- •Concomitant treatment with anticoagulants, such as coumadin or heparin, except to maintain patency of in-dwelling catheters;
- •Prior allergic reactions attributed to compounds of similar chemical or biologic composition to study drug (e.g., rituximab or immunoglobulin G);
- •Ongoing or active infection;
- •Required the use of systemic antibiotics or antifungals for ongoing or recurrent infections. Topical use of antibiotics or antifungals is allowed;
- •Other uncontrolled concurrent illness that would preclude study participation; or Psychiatric illness or social situation that would preclude study participation.
研究组 & 干预措施
Subjects from UPCC 10903
Experimental
干预措施: CP-870,893 (Biological)
结局指标
主要结局
Number of Adverse Events
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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