EUCTR2008-003292-42-BE进行中（未招募）1 期
A Phase 1b/ 2 Trial of AMG 479 or AMG 102 in Combination with Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 213
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Disease related
- •Histologically or cytologically confirmed SCLC
- •Extensive disease, defined by at least one of the following criteria:
- •- No limited disease (ie, no disease confined to the ipsilateral hemithorax, which can be safely encompassed within a tolerable radiation field)
- •- Extrathoracic metastases - Malignant pericardial or pleural effusion
- •- Contralateral hilar adenopathy
- •Measurable or non-measurable disease, as defined by modified RECIST (see
- •Appendix E)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (see
- •Appendix I)
- •Life expectancy (with therapy) = 3 months
- •Demographic
- •Woman or man = 18 years old
- •Before any study-specific procedure, the appropriate written informed consent must
- •be obtained (see Section 12.1)
- •Hematological function (within 3 days prior to enrollment), as follows:
- •- Absolute neutrophil count (ANC) = 1.5 x 109/L
- •- Platelet count = 100 x 109/L
- •- Hemoglobin = 9 g/dL
- •Partial thromboplastin time (PTT) = 1.3 x upper limit of normal (ULN) and
- •international normalized ratio (INR) = 1.3
- •Renal function, as follows:
- •- Creatinine (Cr) clearance (CrCl) = 60 mL/minute (min); calculated by Cockcroft-
- •Gault formula (see Appendix D) as follows:
- •?????? Male CrCl = (140 - age) x (weight in Kg) / (serum Cr x 72)
- •?????? Female CrCl = (140 - age) x (weight in Kg) x 0.85 / (serum Cr x 72)
- •Hepatic function, as follows:
- •- Aspartate aminotransferase (AST) = 2.5 x ULN
- •(= 5 x ULN if attributable to liver metastases)
- •- Alanine aminotransferase (ALT) = 2.5 x ULN
- •(= 5 x ULN if attributable to liver metastases)
- •- Alkaline phosphatase = 2.5 x ULN
- •(= 5 x ULN if attributable to bone and/or liver metastases)
- •- Total bilirubin = 1.5 x ULN
- •(= 3 x ULN for subjects with UGT1A1 promoter polymorphism ie, Gilbert
- •syndrome, confirmed by genotyping or Invader UGT1A1 molecular assay prior to
- •enrollment)
- •Fasting blood glucose = 160 mg/dL (Fasting will require subjects to refrain
- •from all food and beverage [except water] for at least 8 hours)
- •Negative pregnancy test (urine or serum) within 7 days prior to enrollment (women of child-bearing potential only)
- •Plan to begin protocol specific therapy = 7 days after enrollment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 53
排除标准
- •Disease Related
- •Symptomatic or untreated CNS metastasis - Subjects with CNS metastases that are both treated and stably controlled are
- •eligible if all of the following apply:
- •1. therapy has been administered (surgery and/or radiation therapy);
- •2. there is no additional treatment planned for brain metastases;
- •3. the subject is clinically stable; and
- •4. the subject is off corticosteroids or on a stable dose of corticosteroids for at least 2 weeks prior to enrollment
- •Any prior or synchronous malignancy, except:
- •- Malignancy treated with curative intent and with no known active disease present
- •for = 3 years prior to enrollment and felt to be at low risk for recurrence by the
- •treating physician
- •- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •- Adequately treated cervical carcinoma in situ without evidence of disease
- •- Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Cancer Therapy • Prior chemotherapy, chemo-radiation or investigational agent for the treatment of SCLC
- •- Prior palliative radiotherapy to sites of distant metastasis is allowed (if completed
- •= 7 days prior to enrollment)
- •- Prior treatment of CNS metastasis is allowed (as defined in Section 4.2.1)
- •Currently or previously treated with biological, immunological or other anti-tumor
- •therapies for SCLC
- •Prior radiotherapy to > 25% of the bone marrow
- •Medications/Treatments
- •Recent infection requiring systemic anti-infective treatment that was completed = 14 days prior to enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection)
- •Currently being treated with full dose anti-coagulation therapy (ie coumadin
- •with a goal INR between 2 to 3, or full dose low molecular weight heparin)
- •Medical Conditions
- •History of bleeding diathesis
- •Current serious or non-healing wound or ulcer
- •Known positive test for human immunodeficiency virus, hepatitis C, chronic or active
- •hepatitis B
- •Any clinically significant medical or psychiatric condition, co-morbid disease,
- •addictive disorder, or laboratory abnormality (eg, cardiovascular disease or chronic
- •obstructive pulmonary disease), which may increase the risks associated with study
- •participation or study treatments or could interfere with the safe delivery of study
- •treatment or increase risk of toxicity
- •Subject has any kind of disorder that compromises the ability of the subject to give
- •written informed consent and/or to comply with study procedures
- •Major surgical procedure within 28 days prior to enrollment, or not yet recovered
- •from major surgery
- •Minor surgical procedures within 7 days prior to enrollment, or not yet recovered from
- •minor surgery
- •Note: uncomplicated placement of vascular access device = 1 day prior to first
- •administration of study treatment, and fine needle aspiration, thoracocentesis
- •or paracentesis = 3 days prior to first administration of study treatment is
- •Thrombosis or vascular ischemic events within the last twelve months, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction.
- •Inability to tolerate IV drug administration
- •Subject is currently enrolled in or has not yet completed at least 30 days prior to
- •enrollment since ending other investigational device or clinical study(s)
- •Subject of child-bearing potential is evidently pregnant (eg, positive human chorionic
- •gonadotropin
研究者
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