NCT00408967撤回2 期
An Open-label Phase II Study of Two Dose Levels of EMD 273066 Administered With Low-dose Cyclophosphamide Following Objective Response to Second-line Chemotherapy in Women With Recurrent Ovarian Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- EMD Serono
研究概览
简要总结
The purpose of this study is to determine if either of two doses of EMD 273066 when given with a low dose of cyclophosphamide will result in a second time to progression that is as long or longer than the first time to progression
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Age 18 years or older
- •Have histologically documented ovarian carcinoma (including primary peritoneal carcinoma)
- •Have archival tumor tissue available for EpCAM expression determination by immunohistochemistry
- •Received first-line platinum-based chemotherapy of up to 8 cycles (approximately 15 to 24 weeks)
- •Experienced a complete response to first-line platinum-based chemotherapy
- •Experienced a platinum-free interval of at least 6 but not more than 24 months starting at the end of the last cycle of first-line chemotherapy until recurrence
- •Treatment with Avastin (bevacizumab) is permitted during first-line platinum-based chemotherapy through TTP and platinum-based reinduction therapy up to 28 days prior to start of EMD 273066
- •Experienced a partial or complete response after up to 8 cycles of second-line platinum-based chemotherapy
- •Have a CT/MRI scan within 4 weeks prior to starting treatment
- •Be able to start cyclophosphamide and EMD 273066 treatment within 3 to 5 weeks of completion of second-line chemotherapy
- •No clinical history of significantly impaired renal function or chronic kidney disease. Must have an estimated glomerular filtration rate ≥50 mL/min determined by the Cockgroft-Gault-formula
- •WBC count ≥2.5x10³/µL (or total granulocytes ≥1x10³/µL)
- •Absolute lymphocyte count (ALC) ≥0.5x103/µL
- •Platelet count ≥100,000/µL
- •Hemoglobin (Hgb) level ≥9 g/dl
- •ALT and AST ≤2.5xULN, total bilirubin <1.5xULN
- •Serum sodium, potassium and phosphorus within normal limits
- •Serum amylase within normal limits
- •Serologic testing within 4 weeks prior to starting study treatment with negative results for hepatitis C virus (HCV), human immunodeficiency virus (HIV) and hepatitis B virus (HBV) demonstrated by negative hepatitis B core antibody (HBc Ab) and hepatitis B surface antigen (HbsAg)
- •Negative pregnancy test and willingness to use effective contraception for the study duration and 1 month thereafter if of procreative potential
排除标准
- •Dyspnea at rest, exercise intolerance
- •In any subject with clinically significant non-malignant pulmonary disease: Pulmonary function testing (to include Forced Vital Capacity [FVC] and 1-second Forced Expiratory Volume [FEV-1]) showing <70% of predicted values for FVC or FEV-1 and/or DLCO <50%.
- •In any subject with pulmonary or pleural metastatic disease: Arterial oxygen saturation at rest measured transcutaneously on room air < 90% or increased risk for respiratory compromise related to IL2 exposure in the judgment of the investigator.
- •ECG with evidence of clinically significant disease within 4 weeks prior to starting study treatment
- •Cardiac stress test (e.g., exercise or pharmacological thallium test; exercise or pharmacological echocardiography) with abnormal results within 4 weeks prior to starting treatment in subjects who have a history of coronary heart disease (myocardial infarction, angina pectoris or pathologic coronary angiography)
- •Any current evidence of congestive heart failure with NY Heart Association Grade 2 through 4 or echocardiogram with a left ventricular ejection fraction <45% or other signs of clinical significant heart disease
- •History of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other clinically significant arrhythmias
- •Evidence of active brain metastases
- •Previous malignancy other than ovarian cancer in the last 5 years except basal cell cancer of the skin or pre-invasive cancer of the cervix
- •Pregnant or lactating female
- •An immediate need for palliative radiotherapy or systemic corticosteroid therapy
- •Significant active infection
- •Major surgery, chemotherapy, or radiation within 21 days of starting study treatment
- •Received another experimental drug within 28 days of starting study treatment
- •Uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg) or hypotension (systolic ≤90 mmHg)
- •Presence of medically significant third space fluids such as pleural or pericardial effusions or edema of toxicity grade ≥2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 [17].
- •Exception allowed for disease-related peritoneal ascites unless patient requires frequent and repetitive paracentesis management.
- •Previous diagnosis of an autoimmune disease involving a major organ system
- •Transplant recipient on immunosuppressive therapy
- •Acute esophageal or gastroduodenal ulcers
- •History of prior therapy or a serious uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study
研究组 & 干预措施
Tucotuzumab celmoleukin (EMD 273066)
Experimental
干预措施: Tucotuzumab celmoleukin (EMD 273066) (Drug)
研究者
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