PER-050-07已完成未知
A Phase II/III Randomized, Double-Blind Study of Paclitaxel Plus Carboplatin in Combination With Vorinostat or Placebo in Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC)
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2007年8月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1. The patient has a histologically or cytologically confirmed diagnosis of Non-Small Cell Bronchopulmonary Carcinoma (NSCLC) in Stage IIIB or Stage IV.
- •2. Patients have not received prior systemic chemotherapy, with the exception of adjuvant chemotherapy for NSCLC.
- •3. The patient is ≥ 18 years of age at the time of providing informed consent.
- •4. The patient has a measurable disease.
- •5. It has been at least 3 weeks since the patient underwent any major surgery or previous radiation therapy and has adequately recovered from the toxicity or complications of these interventions.
- •6. The patient has a performance status of the Oncological Cooperative Group of the East of 0 or 1.
- •7. Patients have an adequate organic function.
- •8. Female patient, potentially fertile with a negative pregnancy test within 72 days of enrollment in the study.
- •9. The patient agrees: 1) To use 2 contraceptive methods suitable to prevent pregnancy or 2) To abstain from the practice of heterosexual activity throughout the study.
- •10. The patient is available for the periodic extraction of blood samples, evaluations related to the study, and appropriate clinical management at the institution providing the treatment during the course of the study.
- •11. The patient or his legally authorized representative have voluntarily agreed to participate by providing written informed consent.
排除标准
- •1. The patient has been treated with an investigational agent for any indication within 4 weeks of enrollment in the study.
- •2. The patient has an active infection or has received antibacterial, antiviral, or intravenous antifungal drugs within 2 weeks prior to enrollment.
- •3. The patient has a prior history of treatment with HDAC inhibitors.
- •4. The patient is receiving systemic steroids by any indication.
- •5. Patients with untreated brain metastasis or carcinomatous meningitis are excluded.
- •6. The patient can not take and / or tolerate oral drugs continuously,
- •7. The patient is infected by the human immunodeficiency virus (HIV) or an HIV-related malignancy.
- •8. The patient has active hepatitis A, B or C infection.
- •9. The patient is pregnant or breastfeeding.
- •10. The patient has a known allergy or hypersensitivity to any component of vorinostat or carboplatin.
- •11. The patient has a history of gastrointestinal surgery or another procedure that may interfere with the absorption or intake of the
- •study drugs.
- •12. The patient has an uncontrolled concurrent illness or circumstances that could limit compliance with the study.
- •13. The patient has a preexisting grade 2 or higher neuropathy.
- •14. The patient presents a history of previous malignancy.
- •15. The patient is eligible for treatment with bevacizumab in combination with paclitaxel plus carboplatin, and bevacizumab is available for the individual patient, and treatment with bevacizumab in combination with paclitaxel plus carboplatin is considered the preferred treatment.
研究者
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