EUCTR2010-022950-17-GB进行中（未招募）1 期
A Phase 1/2 Study to Assess the Safety and Efficacy of Lorvotuzumab Mertansine (IMGN901) in Combination with Carboplatin/Etoposide in Patients with Advanced Solid Tumors including Extensive Stage Small Cell Lung Cancer - N/A
ImmunoGen, Inc0 个研究点目标入组 181 人开始时间: 2011年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 181
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
入选标准
- •1. Male or female patients =18 years old at the time of signing Informed Consent
- •2. Diagnosis
- •Patients with histologically or cytologically confirmed SCLC and extensive disease as defined by the Veterans Administration Lung Cancer Group
- •3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •4. Prior therapy
- •No prior systemic chemotherapy for the treatment of SCLC
- •Previous radiotherapy, including cranial irradiation, is allowed if < 30% of marrow-bearing bones were irradiated and if radiotherapy was completed at least 7 days prior to enrollment and the patient has recovered or stabilized from all adverse effects of prior radiotherapy
- •5. Major surgery (this does not include placement of vascular access device or tumor biopsies) must be completed 4 weeks prior to Day 1
- •6. Patients must have at least one measurable lesion per RECIST 1.1 guidelines for solid tumors.
- •7. Patients must have the following laboratory values:
- •Absolute Neutrophil Count (ANC) = 1.5 x 109/L (1500/mm3)
- •Platelets =100.0 x 109/L (100,000/mm3)
- •Hemoglobin (Hgb) =9 g/dL
- •Serum total bilirubin =1.5 x ULN (upper limit of normal)
- •AST (SGOT) and ALT (SGPT) =2.5 x ULN, except for patients with tumor involvement of the liver who must have AST and ALT =5 x ULN
- •Serum creatinine =1.5 x ULN or 24-hour creatinine clearance =60 mL/min
- •Amylase and lipase must be =1.5 x ULN
- •8. Patients must be willing and able to adhere to the study visit schedule and other protocol requirements
- •9. Patients or a legally authorized representative must understand and voluntarily sign an Informed Consent
- •10. Women of child bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months) must agree to use 2 contraceptive methods (e.g., oral, parenteral, or implantable hormonal contraceptive; tubal ligation; intra-uterine device;
- •barrier contraceptive with spermicide; partner's latex condom or vasectomy). WCBP must agree to follow these requirements for at least 4 weeks after the last dose of study drug
- •11. WCBP must have a negative pregnancy test prior to the first dose of study treatment
- •12. Male patients must agree to use a latex condom even if he has had a successful vasectomy and continue to follow these requirements for at least 4 weeks following the last dose of study drug
- •13. Predicted survival of 3 months or more
- •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 88
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 72
排除标准
- •1. Concurrently receiving other anti-neoplastic treatment (e.g. chemotherapy, investigational therapy or immunotherapy including steroid therapy)
- •2. Grade =2 neurotoxicity
- •3. Any serious medical condition including laboratory abnormalities, or psychiatric disorder that in the opinion of the Investigator places a patient at unacceptable risk if he/she were to participate in the study
- •4. Clinically relevant active infection including known active hepatitis B or C, Human Immunodeficiency Virus (HIV) infection, varicella-zoster virus (shingles) or cytomegalovirus infection or any other known concurrent infectious disease which, in the judgment of the Investigator, would make a patient inappropriate for enrollment into this study
- •5. Significant cardiac disease such as recent myocardial infarction (=6 months prior to Day 1), unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled hypertension (recurrent or persistent increases in systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg ), uncontrolled cardiac arrhythmias, severe aortic stenosis, or = grade 3 cardiac toxicity following prior chemotherapy
- •6. History of neurologic disease such as multiple sclerosis or other demyelinating disease; paraneoplastic neurologic syndrome such as Eaton-Lambert syndrome, encephalomyelitis or sensory neuropathy;
- •central nervous system (CNS) injury with residual neurological deficit; or has a history of hemorrhagic or ischemic stroke within the last 6 months
- •7. Patients with CNS metastases excluded unless previously treated with surgery or radiation and on stable, decreasing or no steroids. Patients with asymptomatic CNS metastases are eligible unless requiring steroids, anticonvulsants or other treatments to manage their CNS disease.
- •8. Patients with uncontrolled carcinoid syndrome (flushing, uncontrolled diarrhea, labile blood pressure)
- •9. Known hypersensitivity to previous monoclonal antibody therapy or maytansinoids
- •10. Patients with previous history of hypersensitivity or anaphylactic reaction to IMGN901 or any of its excipients
- •11. Patients with previous history of hypersensitivity to etoposide or any component of its formulation
- •12. Patients with previous history of allergic reaction to platinum-containing compounds
- •13. Prior active malignancy within the last 3 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer
- •14. Patients with a history of chronic pancreatitis or metastatic disease involving the pancreas that has been associated with an increased amylase and/or lipase
- •15. WCBP who are pregnant or lactating
研究者
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