NCT00165347已完成2 期
Phase II Study of PTK787/ZK222584 in Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- To determine the effectiveness of PTK in treating patients with relapsed or refractory myeloma
研究概览
简要总结
The purpose of this study is to determine whether or not cancer cells in the body are affected by PTK and whether it affects the growth of these cells.
详细描述
Patients will take PTK orally once a day for the duration of their time on the study. Each cycle of chemotherapy will last for 4 weeks.
Measurement of vital signs will be done weekly during the first month of treatment.
Physical exam, vital signs, blood work, a quality of life assessment, and x-ray or MRI wil be performed every 4 weeks.
Patients will remain on the study until their disease fails to respond to treatment or there are intolerable side effects. Typically treatment is performed for 12 weeks and up to one year in patients that are stable and responding.
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
- •Older than 18 years of age.
- •Confirmed diagnosis of active progressive multiple myeloma
- •History of > 2 prior cytotoxic treatment regimens. Bone marrow transplantation will be considered as one regimen.
- •Current measurable disease based on serum and/or urine M protein and/or measurable plasmacytoma.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Absolute neutrophil count (ANC) > 1,500 mm3
- •Platelets > 100,000 mm3
- •Serum creatinine < 1.5 upper limit of normal (ULN)
- •Serum bilirubin < 1.5 ULN
- •AST/AGOT and ALT/SGPT < 3.0 ULN
- •Life expectancy > 12 weeks
排除标准
- •Chemotherapy < 3 weeks prior to registration.
- •Biologic or immunotherapy < 2 weeks prior to registration
- •Full field radiotherapy < 4 weeks or limited field radiotherapy < 2 weeks prior to registration.
- •History or presence of central nervous system (CNS) disease
- •History of leukemia
- •History of another primary malignancy with the exception of inactive basal or squamous cell carcinoma of the skin
- •Major surgery < 4 weeks prior to registration
- •Prior therapy with anti-vascular endothelial growth factor (VEGF) agents excluding thalidomide, Revimid, velcade and arsenic trioxide
- •Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- •Pleural effusion or ascites that cause respiratory compromise
- •Female patients that are pregnant or breast feeding
- •Uncontrolled high blood pressure, history of labile hypertension or history of poor compliance with an antihypertensive regimen
- •Unstable angina pectoris
- •Symptomatic congestive heart failure
- •Myocardial infarction < 6 months prior to registration
- •Serious uncontrolled cardiac arrhythmia
- •Uncontrolled diabetes
- •Active or uncontrolled infection
- •Acute or chronic liver disease
- •Impairment of gastrointestinal (GI) function or GI disease
- •Confirmed HIV infection
结局指标
主要结局
To determine the effectiveness of PTK in treating patients with relapsed or refractory myeloma
次要结局
- to investigate the safety of PTK in patients with relapsed/refractory multiple myeloma
- To evaluate the progression free survival of patients treated with PTK
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
PTK787 in Patients With Advanced Metastatic Pancreatic AdenocarcinomaNeoplasmNCT00226005Pancreatic Cancer Research Team67
已完成
2 期
PTK787/ZK 222584 in Treating Patients With Unresectable Malignant MesotheliomaMalignant MesotheliomaNCT00053885Alliance for Clinical Trials in Oncology47
进行中（未招募）
2 期
Assessing a ctDNA and PET-oriented Therapy in Patients With DLBCL A Multicenter, Open-label, Phase II Trial.Diffuse Large B-cell LymphomaNCT04604067Swiss Cancer Institute260
已完成
1 期
MK-8237 (SCH900237) Biomarker Study in Participants With Allergic Rhinitis or Rhinoconjunctivitis (MK-8237-009)Allergic RhinoconjunctivitisAllergic RhinitisNCT01852825Merck Sharp & Dohme LLC26
终止
不适用
PET/CT in Evaluating Response to Chemotherapy in Patients With Breast CancerHER2-positive Breast CancerRecurrent Breast CancerStage IA Breast CancerStage IB Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast CancerNCT01712815University of Southern California12