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
- 试验地点
- 13
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens. The previous treatment must include a platinum-based chemotherapy. Approximately 720 patients will receive best supportive care (not including any anti-cancer therapy) and be randomly assigned at a ratio of 2:1 to talactoferrin or placebo. Patients would receive the above therapy until the occurrence of progressive disease (PD), start of a next-line therapy for NSCLC, unacceptable toxicity, withdrawal of consent, or withdrawal by investigator, whichever occurs first. Safety will be assessed throughout the study by the occurrence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v 3.0, and changes in vital signs, physical examination, and laboratory values. Globally the enrollment target is 720 patients. In India the enrollment target is 200 patients. The tentative date of enrollment of first patient in India is July 15, 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age greater than and equal to 18 yrs
- •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.
结局指标
主要结局
Overall survival
时间窗: After the occurrence of the required number of events
次要结局
- Progression free survival(At time of final analysis)
- Objective response and disease stabilization rate(At time of final analysis)
- Survival Rate(Six month and one year)
- Safety and tolerability(At time of final analysis)