EUCTR2009-012709-20-BG进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 742
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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 408
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 334
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 investigator’s 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 ß-human chorionic gonadotropin [ß-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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