PER-124-09已完成未知
FORTIS-M: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Oral Talactoferrin in Addition to Best Supportive Care in Patients With Non-small Cell Lung Cancer Who Have Failed Two or More Prior Treatment Regimens
Agennix Incorporated,0 个研究点目标入组 0 人开始时间: 2010年1月29日最近更新:
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
- 18 至 70（—）
入选标准
- •Histologically or cytologically confirmed stage IIIB or IV NSCLC
- •Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic NSCLC
- •At least one target lesion that is unirradiated and measurable by RECIST
- •Adequate hematologic, renal and hepatic function
- •ECOG 0, 1, or 2
- •Able to understand and sign an Informed Consent
排除标准
- •Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
- •Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
- •History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for = 5 years
- •Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
- •Serious active infection
- •Psychiatric illness/ social situations that would limit study compliance
- •Other uncontrolled serious chronic disease or conditions that in the investigator´s opinion could affect compliance or follow-up in the protocol
- •Concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
- •Known HIV positive or on active anti-retroviral therapy
- •Known Hepatitis B surface antigen positive or hepatitis C positive
- •Receipt of any investigational medication within 4 weeks prior to randomization
- •Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment
- •Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
- •Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
研究者
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