EUCTR2005-000949-11-GR进行中（未招募）1 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Oral Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) in Patients With Advanced Malignant Pleural Mesothelioma Previously Treated With Systemic Chemotherapy - Phase III Advanced Mesothelioma Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 660
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
- •a.Patient must have a histologically and/or cytologically confirmed diagnosis of epithelial, sarcomatoid, or mixed histology malignant pleural mesothelioma and:
- •?In countries where pemetrexed is an approved mesothelioma treatment, the patient's mesothelioma has progressed or relapsed following treatment with at least one prior chemotherapy regimen with pemetrexed and either cisplatin or carboplatin.
- •?In countries where pemetrexed is not approved for mesothelioma, the patient's mesothelioma has progressed or relapsed following treatment with at least one prior chemotherapy regimen.
- •?In the opinion of the investigator, pemetrexed is not the preferred therapy for the patient, and the patient's mesothelioma has progressed or relapsed following treatment with at least one prior chemotherapy regimen.
- •NOTE: If patient was not previously treated with pemetrexed, please document reason in the patients study record, i.e.: not approved, contraindicated for patient, reimbursement not available, or other reason to be specified.
- •b.Patient must have received no more than 2 prior systemic therapy regimens.
- •c.Patient must have an area of pleural rind thickness measured by meso-modified RECIST [10] that is at least 1.0 cm in line-length on a spiral computerized tomography (CT) scan.
- •e.Patient has a Karnofsky performance scale status of =70 (see Appendix 1).
- •j.Patient must have completed previous chemotherapy or radiotherapy at least 4 weeks before drug administration (6 weeks for nitrosoureas or mitomycin C) and have recovered from any treatment-related toxicities (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade =1 or recovered to pre-treatment levels).
- •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
- •a. Patient had prior treatment with an HDAC inhibitor (e.g., Depsipeptide, MS 275, LAQ-824, PXD-101, and valproic acid). Patients who have received such agents for other indications, e.g. epilepsy, may enroll on vorinostat trials after a 30-day washout period.
- •b.Patient has an active infection for which the patient received intravenous antibiotic, antiviral, or antifungal medications within 2 weeks prior to the start of study drug.
- •c.Patients with a currently active second malignancy other than non-melanoma skin cancers and carcinoma in situ of the cervix are not eligible. Patients are not considered to have a currently active second malignancy if they have completed therapy for the second malignancy and are disease free from prior malignancies for >5 years.
- •d.Patient has uncontrolled brain metastases, e.g., previously treated brain metastases that is not stable in the last 6 weeks.
- •e.Patient has a known human immunodeficiency virus (HIV) infection or HIV-related malignancy.
研究者
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