CTRI/2010/091/000034已完成3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
入排标准
入选标准
- •1. Age greater than and equal to 18 yrs
- •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
- •4. At least one target lesion that is unirradiated and measurable by RECIST
- •5. Adequate hematologic, renal and hepatic function
- •6. ECOG 0, 1, or 2
- •7. Able to understand and sign an Informed Consent
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. Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
- •3. 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
- •4. Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
- •5. Serious active infection
- •6. Psychiatric illness/ social situations that would limit study compliance
- •7. Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
- •8. 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)
- •9. Known HIV positive or on active anti-retroviral therapy
- •10. Known Hepatitis B surface antigen positive or hepatitis C positive
- •11. Receipt of any investigational medication within 4 weeks prior to randomization
- •12. 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
- •13. Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
- •14. Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
研究者
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