EUCTR2009-012709-20-IT进行中（未招募）不适用
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 - FORTIS-M
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AGENNIX INC.
- 入组人数
- 720
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.Age ? 18 years
- •2.Histologically or cytologically confirmed stage IIIB or IV NSCLC
- •3.Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic NSCLC. The following criteria must be satisfied:
- •Failure is defined as disease progression or unacceptable toxicity
- •The patient must have received a platinum-containing regimen for advanced or metastatic NSCLC
- •Failure to the most recent systemic anti-cancer regimen must have occurred
- •4.At least one target lesion that is unirradiated and measurable by RECIST
- •5.Hemoglobin ≥ 9.0 g/dL
- •6.Absolute neutrophil count ≥ 2000/mm3
- •7.Lymphocytes ≥ 800/mm3
- •8.Platelet count ≥ 100,000/mm3
- •9.Total bilirubin ≤ 1.5 mg/dL
- •10.Creatinine ≤ 2.0 mg/dL
- •11.AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal (ULN)
- •12.Lactate dehydrogenase ≤ 1.5 x ULN
- •13.Karnofsky performance status of >50 (ECOG 0, 1, or 2)
- •14.Life expectancy of >12 weeks
- •15.Able to understand and sign an informed consent
- •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.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
- •2.History of allergic reactions to compounds of similar chemical or biologic composition to talactoferrin
- •3.Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
- •4.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
- •5.Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
- •6.Serious active infection
- •7.Psychiatric illness / social situations that would limit study compliance
- •8.Other uncontrolled serious chronic disease or conditions that in the investigators opinion could affect compliance or follow-up in the protocol
- •9.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)
- •10.Known HIV positive or on active anti-retroviral therapy
- •11.Known Hepatitis B surface antigen positive or hepatitis C positive
- •12.Receipt of any systemic anti-cancer regimen or investigational medication within 4 weeks prior to randomization
- •13.Pregnant or lactating patients, or fertile female patients with a positive pregnancy test (serum -human chorionic gonadotropin [-hCG] at screening or at baseline), or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment
- •14.Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
- •15.Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
- •16.Oral corticosteroid therapy within 4 weeks prior to randomization or expected to be ongoing during the study, except replacement therapy for adrenal insufficiency
研究者
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