NCT00526149已完成2 期
Multicenter Parallel Phase II Trial of BI 2536 Administered as One Hour IV Infusion Every 3 Weeks in Defined Cohorts of Patients With Various Solid Tumors. A New Drug Screening Program of the EORTC Network of Core Institutions (NOCI)
European Organisation for Research and Treatment of Cancer - EORTC1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2007年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Confirmed objective response rate (complete and partial responses) as defined by RECIST
研究概览
简要总结
RATIONALE: BI 2536 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well BI 2536 works in treating patients with recurrent or metastatic solid tumors.
详细描述
OBJECTIVES:
- Investigate if BI 2536 demonstrates antitumor activity in the selected tumor types.
- Further document its safety profile in the treated patient population.
- Describe the plasma concentration time-course following administration of a single administration of BI 2536 in patients with different tumor types using an appropriate population pharmacokinetic model.
OUTLINE: This is a multicenter study.
Patients receive BI 2536 IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Blood is collected periodically during study. Plasma samples are analyzed for pharmacokinetic studies by HPLC and tandem mass spectrometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Tumor-specific criteria:
- •Head and neck cancer:
- •Histologically or cytologically proven squamous cell carcinoma of the head and neck (excluding nasopharyngeal primaries)
- •Patients presenting with new non-irradiated lesions in pre-irradiated field as target lesions are eligible
- •Recurrent or metastatic disease, no longer suitable for local therapy
- •Prior use of chemotherapy/chemoradiotherapy/EGFR inhibitors for the treatment of the primary disease/nonmetastatic disease is allowed
- •No prior chemotherapy for recurrent or metastatic disease
- •Prior treatment with EGFR inhibitor for metastatic advanced disease is allowed
- •Breast cancer
- •Histologically proven recurrent or metastatic adenocarcinoma of the breast that failed prior taxane and anthracycline therapy
- •Patient must have had a minimum of one line and a maximum of 2 lines of chemotherapy treatment given either as adjuvant treatment or for recurrence/metastatic disease
- •Patients who do not qualify for Her-2-based therapy allowed
- •Hormone receptor status not specified
- •Ovarian cancer
- •Histologically proven ovarian epithelial cancer
- •Metastatic or inoperable locally advanced disease
- •Patients either progressing under or relapsing within 6 months of completion of any line of platinum and taxane-based therapeutic regimen for advanced disease
- •Soft tissue sarcoma
- •Histologically proven advanced and/or metastatic malignant soft tissue sarcoma of high or intermediate grade and one of the following histologies defined by the WHO classification 2002:
- •Leiomyosarcoma, adipocytic sarcoma, synovial sarcoma, and others
- •Fibroblastic (adult fibrosarcoma, myxofibrosarcoma, sclerosing epithelioid fibrosarcoma)
- •So-called fibrohistiocytic (pleomorphic malignant fibrous histiocytoma [MFH], giant cell "MFH", inflammatory "MFH")
- •Malignant glomus tumors
- •Skeletal muscles (rhabdomyosarcoma, alveolar or pleomorphic) excluding embryonic rhabdomyosarcoma
- •Vascular (epithelioid hemangioendothelioma, angiosarcoma)
- •Uncertain differentiation (synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, perivascular epithelioid cell tumour [PEComa], intimal sarcoma) excluding chondrosarcoma, Ewing tumors/primitive neuroectodermal tumor (PNET)
- •Malignant peripheral nerve sheath tumors
- •Malignant solitary fibrous tumors
- •Undifferentiated soft tissue sarcomas not otherwise specified
- •Other types of sarcoma (not listed as not eligible), if approved by the Study Coordinator (written or e-mail approval needed prior to registration)
- •Excluded are any of the following:
- •Embryonic rhabdomyosarcoma
- •Chondrosarcoma
- •Osteosarcoma
- •Ewing tumors/primitive neuroectodermal tumors
- •Gastrointestinal stromal tumor
- •Dermatofibrosarcoma protuberans
- •Inflammatory myofibroblastic sarcoma
- •Neuroblastoma
- •Malignant mesothelioma
- •Mixed mesodermal tumors of the uterus
- •Patients must have received no more than one combination or two single agents of chemotherapy regimen for advanced disease and treatment must have included an anthracycline if not medically contraindicated
- •Histologically proven metastatic malignant melanoma
- •Ocular melanomas are excluded
- •Patients must either not have received any prior chemotherapy for recurrent /metastatic disease or have received one line of chemotherapy pending LDH ≤ 2 times upper limit of normal (ULN)
- •One prior line of immunotherapy is allowed
- •General criteria:
- •Measurable disease, defined as unidimensionally measurable based on RECIST with a target lesion of at least 20 mm or 10 mm measured by spiral CT scan
- •Documented progressive disease proven by imaging prior to study entry (i.e., progression should be documented by 2 imaging scans performed within the past 6 months prior to registration showing progression according to RECIST)
- 另有 34 项未显示
排除标准
- 未提供
结局指标
主要结局
Confirmed objective response rate (complete and partial responses) as defined by RECIST
次要结局
- Overall progression-free survival
- Clinical benefit as assessed by RECIST
- Duration of response
- Overall survival
- Safety as assessed by CTCAE version 3.0
研究者
研究点 (1)
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