EUCTR2007-006713-16-GB进行中（未招募）1 期
Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients with Metastatic Malignant Melanoma
ImClone Systems Incorporated0 个研究点目标入组 104 人开始时间: 2008年7月25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
- 104
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. The patient has histologically or cytologically confirmed cutaneous malignant melanoma that is American Joint Committee on Cancer (AJCC) stage IV (metastatic).
- •2. The patient is = 18 years of age.
- •3. The patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.
- •4. The patient has completed any prior radiotherapy, biologic/immunotherapy or vaccine therapy (for adjuvant or advanced disease) at least 6 weeks prior to the first dose of study therapy.
- •5. The patient has a life expectancy > 3 months.
- •6. The patient has evidence of measurable disease as defined by RECIST.
- •7. The patient has resolution of all clinically significant toxic effects of prior cancer therapy to grade = 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 (NCI-CTCAE).
- •8. The patient has adequate hematological functions (absolute neutrophil count [ANC] = 1500 cells/µL, hemoglobin = 9 g/dL and platelets = 100,000 cells/µL).
- •9. The patient has adequate hepatic function (bilirubin within normal limits [WNL], aspartate transaminase [AST] and/or alanine transaminase [ALT] = 3.0 times the upper limit of normal [ULN], or = 5.0 times the ULN if the transaminase elevation is due to liver metastases).
- •10. The patient has serum creatinine = 1.5 x ULN (or a calculated creatinine clearance > 60 mL/min).
- •11. The patient’s urinary protein = 1+ on dipstick or routine urinalysis ([UA]; if urine dipstick or routine analysis is = 2+, a 24-hour urine for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study).
- •12. The patient must have adequate coagulation function as defined by International Normalized Ratio (INR) = 1.5 and a partial thromboplastin time (PTT) = 1.5 X ULN. Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight (LMW) heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices).
- •13. The patient is able to provide informed written consent.
- •14. The patient, if sexually active, must be post-menopausal (last menstrual period > 2 years prior to study), surgically sterile, or is using an effective method of contraception in the opinion of the investigator.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The patient has mucosal or intra-ocular melanoma.
- •2. The patient has known or suspected brain or leptomeningeal metastases.
- •3. The patient has had prior cytotoxic chemotherapy for metastatic malignant melanoma.
- •4. The patient has had more than one line of biologic, immunologic, or vaccine-based therapy for metastatic malignant melanoma (not including adjuvant therapy).
- •5. The patient has a concurrent active malignancy other than adequately treated non-melanomatous skin cancer or other non-invasive carcinoma or in situ neoplasm. A patient with previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years.
- •6. The patient has a nonhealing wound or ulcer.
- •7. The patient has a known alcohol or drug dependency.
- •8. The patient is pregnant or lactating.
- •9. The patient has a coexisting medical or psychiatric problem of sufficient severity to limit compliance with the study and/or increase the risks associated with study participation or study drug administration or interfere with the interpretation of study results.
- •10. The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator.
- •11. The patient has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
- •12. The patient has uncontrolled or poorly controlled hypertension despite standard medical management (>140 mmHg systolic or > 90 mmHg diastolic).
研究者
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