CTRI/2012/09/002972招募中未知
A Prospective, Observational, Open-Label, Non-Randomized, Single Dose, Single centre, Two way, Parallel group, Bioequivalence Study of Two Formulations of Pemetrexed in Indian Adult Chemo-Naïve, Adenocarcinoma NSCLC Patients.
INVESTIGATOR INITIATED TRIA0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •Male and female patients in the age group of 18 to 80 years inclusive of both years
- •Patients with a histologic or cytologic diagnosis of Adenocarcinoma - NSCLC Stage IIIA, IIIB, or IV not amenable to curative treatment surgery or radiotherapy
- •Patients must be chemo-naive
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •If Patients had received prior radiotherapy, then it must be < 25% of bone marrow whole pelvis not allowed
- •Patients with ANC > 1500 cells/mm3
- •Patients with platelet count > 100,000 cells/mm3
- •Patients with hemoglobin > 9 g/dL
- •Current use of an acceptable form of double-barrier birth control
排除标准
- •Patients for whom, in the opinion of the investigator, their general status would not permit the administration of the study drugs or meet any of the study end points
- •Patients with history of any other cancer including squamous NSCLC
- •Patients who are taking other anti cancer agents
- •Patients with other serious concomitant systemic disorder in addition to NSCLC that would make it difficult to complete the study at the discretion of the investigator
- •Patients with any other major organ malfunction, including cardiac conditions and interstitial lung disease
- •Patients with fluid retention â?? Pleural Effusion / Ascitis that cannot be controlled by drainage
- •Patients with peripheral neuropathy >= Grade 1 as per National Cancer Institute Common Toxicity Criteria
- •Patients with creatinine clearance of < 45mL/min as calculated by the modified Cockfort and Gault lean body mass formula
- •Patients with bilirubin > 1.5 times of the ULN
- •Patients without hepatic metastases whose AST/ALT > 3.0 times the ULN
- •Patients with hepatic metastases whose AST/ALT > 5.0 times the ULN
- •Patients with active infection
- •Patients with known history of HIV
- •Patients hypersensitive to Pemetrexed or to any of the excipients
- •Patients who are on non steroidal anti - inflammatory drugs (aspirin, ibuprofen, etc.) or may need to use them during the study
- •Patients who may need concomitant administration of substances that are also tubular secreted (e.g., Probenecid)
- •Patients with a life-expectancy of < 6 months as per the investigatorâ??s discretion
- •Female Patients who are pregnant / planning to become pregnant
- •Patients who are Lactating mothers
- •Inability of the patient and/or legally acceptable representative to give the informed consent
- •Patients who are participating in another clinical trial currently
研究者
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