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临床试验/EUCTR2004-004648-29-DE
EUCTR2004-004648-29-DE进行中（未招募）不适用

A Multicenter, Open-label, Phase 2 Study of VELCADE (bortezomib) for Injection in Previously Treated Patients with Stage IIIB and IV Bronchioloalveolar Carcinoma and Adenocarcinoma with Bronchioloalveolar Features - VANTAGE

Janssen Cilag International, N.V. (Sponsor in European Union)0 个研究点目标入组 135 人开始时间: 2005年4月22日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
135
研究概览入排标准研究者记录与标识符相似试验

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

  • •1. Have histologically confirmed BAC or adenocarcinoma with BAC features.
  • •2. Have stage IIIB (malignant pleural effusion) or stage IV disease.
  • •3. Have disease that has progressed on or after treatment with an EGFR TKI
  • •(Iressa or Tarceva).
  • •4. Have radiographic documentation of Progressive Disease (PD) as determined by
  • •the investigator.
  • •5. Have measurable disease by RECIST, defined as at least 1 lesion that can be
  • •accurately measured in at least 1 dimension as >20 mm with conventional tech-
  • •niques or >10 mm with spiral CT scan; the longest diameter is to be recorded.
  • •6. Are 18 years of age or older.
  • •7. Have a life expectancy greater than 3 months.
  • •8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of
  • •0, 1, or 2.
  • •9. Are able to provide written informed consent in accordance with all applicable
  • •regulations and follow the study procedures. Patients must be capable of un-
  • •derstanding the investigational nature, potential risks and benefits of the study.
  • •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. Have a histological diagnosis of BAC or adenocarcinoma with BAC features based
  • •solely on the following sample types:
  • •·fine needle aspirate (FNA)
  • •·sputum cytology
  • •·bronchial brushings and washings cytology (bronchioalveolar lavage)
  • •·bronchial biopsy (bronchial wall only with no alveolar parenchyma, or
  • •mediastinoscopy with lymph node metastasis only).
  • •2. Have had conventional cytotoxic chemotherapy within 3 weeks prior to en-
  • •rollment or treatment with an EGFR TKI within 2 weeks prior to enrollment.
  • •3. Have peripheral neuropathy of Grade 2 or greater intensity, as defined by the
  • •National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
  • •(CTCAE 3.0).
  • •4. Have documented greater than 10% weight loss in the 6 weeks prior to
  • •enrollment.
  • •5. Have been previously treated with VELCADE.
  • •6. Have experienced myocardial infarction within 6 months prior to enrollment or
  • •have New York Hospital Association (NYHA) Class III or IV heart failure, un-
  • •controlled angina, electrocardiographic evidence of acute ischemia, or clinically
  • •significant and poorly controlled arrhythmias.
  • •7. Have had radiation therapy within 4 weeks prior to enrollment.
  • •8. Have had monoclonal antibody therapy within 4 weeks prior to enrollment.
  • •9. Have had any major surgery within 4 weeks prior to enrollment
  • •10. Have inadequate organ function at the Screening Visit as defined by the
  • •following laboratory values:
  • •- Platelet count <100 x 109/l
  • •- Hemoglobin <8.0 g/dl
  • •- Absolute neutrophil count (ANC) <1.5 x109/l
  • •- Aspartate transaminase (AST) >3 times the upper limit of the normal range
  • •- Alanine transaminase (ALT) >3 times ULN
  • •- Creatinine >1.8 mg/dl
  • •- Total bilirubin >1.5 times ULN or >=5 times ULN in patients with liver
  • •11. Have brain metastases that have not been completely resected or have not
  • •completely responded to treatment with radiation therapy and there is evidence
  • •of residual disease; or that require ongoing treatment with corticosteroids.
  • •12. Have uncontrolled active systemic infection requiring treatment
  • •13. Have evidence of a co-existing advanced or metastatic malignancy other than
  • •BAC or adenocarcinoma with BAC features.
  • •14. Have a history of allergic reaction attributable to compounds containing boron or
  • •15. Have known human immunodeficiency virus (HIV) positive or hepatitis B surface
  • •antigen-positive status or known active hepatitis C infection. Patients assessed
  • •by the investigator to be at risk for HIV, hepatitis B or C infection should be
  • •tested in accordance with local regulations.
  • •16. Have poorly controlled hypertension, diabetes mellitus, or another serious
  • •medical or psychiatric illness that could, in the investigator's opinion, potentially
  • •interfere with the completion of treatment according to this protocol.
  • •17. Are a pregnant or breast-feeding female. Confirmation that the patient is not
  • •pregnant must be established by a negative serum or urine beta-human
  • •chorionic gonadotropin (beta-hCG) pregnancy test result obtained during the
  • •Screening Period. Pregnancy testing is not required for post-menopausal or
  • •surgically sterilized women.
  • 另有 2 项未显示

研究者

发起方
Janssen Cilag International, N.V. (Sponsor in European Union)

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