NCT00374179已完成1 期
A Phase 1, Escalating Dose Study of CT-322, a VEGFR-2 Antagonist, as Monotherapy in Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Safety and tolerability of CT-322
研究概览
简要总结
RATIONALE: CT-322 may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer.
PURPOSE: This phase I trial is studying the side effects of CT-322 in treating patients with advanced solid tumors or non-Hodgkin's lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •DISEASE CHARACTERISTICS
- •Histologically proven advanced solid malignancy or NHL for which no standard therapy exists or for which standard therapy had failed
- •No known brain or leptomeningeal disease
- •No prior bone marrow transplant or stem cell rescue
- •No histologically confirmed squamous non-small cell lung cancer (NSCLC) with central chest tumor(s) still in place
- •PATIENT CHARACTERISTICS
- •* 18 and over
- •Performance status:
- •* ECOG performance status ≤ 2
- •Life expectancy:
- •* > 3 months
- •Hematopoietic:
- •ANC ≥ 1500/mL
- •Platelets ≥ 100,000/mL
- •Hemoglobin ≥ 9.0 g/dL; and not requiring transfusion > 1 unit/month
- •AST and ALT ≤ 2.5 x ULN; if liver function abnormalities are due to the underlying malignancy, then AST and ALT may be ≤ 5 x the ULN
- •Bilirubin ≤ 1.5 x ULN
- •aPTT and PT < 1.5 x ULN
- •Creatinine ≤ 1.5 x ULN; patients with serum creatinine > 1 x ULN must also have creatinine clearance (based on a 24-hour urine collection) ≤ 60 mL/min
- •No proteinuria > 1+ on dipstick analysis; in the case of > 1+ dipstick proteinuria, a 24-hour urine collection for protein must be < 500 mg/24 hours
- •Urinary protein/creatinine ratio < 1
- •No glomerulonephritis
- •Cardiovascular:
- •No coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina, symptomatic congestive heart failure, severe uncontrolled hypertension, hemorrhagic or thrombotic stroke or any other CNS bleeding within the preceding 12 months
- •LVEF normal by echocardiogram or MUGA within the past 12 months if there was prior exposure to anthracyclines or radiotherapy encompassing the heart
- •Immunologic:
- •* Not known to have human immunodeficiency virus (HIV), active hepatitis virus C (HVC), or active hepatitis virus B (HVB)
- •Negative pregnancy test within 7 days prior to enrollment
- •Not pregnant or breast feeding
- •Fertile patients must agree to use effective contraception or commit to abstinence during the study period, or be surgically sterile
- •No serious nonhealing wound, ulcer, or bone fracture
- •Have the ability to understand and sign an informed consent document
- •Be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •At least 4 weeks since prior biological or immunotherapy and recovered
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy and recovered
- •At least 6 weeks for mitomycin C and nitrosoureas prior to study entry and recovered
- •Radiotherapy:
- •* At least 4 weeks since prior radiotherapy to a visceral organ and recovered
- •At least 4 weeks since prior major or laparoscopic surgery and recovered
- •At least 1 week since prior minor surgery
- •No other concurrent anticancer therapy
- •Not concurrently enrolled in another therapeutic clinical trial involving ongoing therapy
- •No concurrent full dose, therapeutic anti-coagulation with warfarin or related oral anti-coagulants or unfractionated or low molecular weight heparins; low dose warfarin for catheter prophylaxis or acetylsalicylic acid ≤ 325 mg/day is acceptable
排除标准
- 未提供
结局指标
主要结局
Safety and tolerability of CT-322
时间窗: Throughout the study
次要结局
- To evaluate the pharmacokinetics of CT-322 in these patients;(Throughout the study)
- to assess whether antibodies to this drug develop in these patients; and(Throughout the study)
- to make a preliminary assessment of the biological activity of CT-322 to alter tumor growth.(Throughout the study)
研究者
研究点 (6)
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