CTRI/2017/04/008305招募中4 期
A two arm, randomized, multicentric, open label, efficacy and safety study of Docetaxel Lipid Suspension (DLS) for Injection of Intas Pharmaceuticals Limited, India in Non-Small Cell Lung Cancer patients. - NA
试验速览
- 阶段
- 4 期
- 状态
- 招募中
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.Patient willing and able to give informed consent to participate in the study.
- •2. Male and Female patients >=18 years and <=65 years of age at screening.
- •3. Patient with histologically/cytologically confirmed locally advanced or metastatic NSCLC after platinum therapy failure.
- •4. Patient should have at least one measurable lesion as per RECIST 1.1.
- •5. Patient must have an adequate bone marrow, renal, cardiac and hepatic function as
- •defined by the following parameters
- •-Bone marrow function-ANC greater than 1500/mm3, Platelet count greater than 100,000/mm3. Hemoglobin Greater than 9.0 g/dL.
- •-Renal function- Serum Creatinine < 1.5 times ULN.
- •-Hepatic function- Serum Bilirubin
- •-LVEF- > 50%.
- •6. Patient should be able to comply with study procedures in the opinion of the investigator.
- •7. Patient with a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG)
- •8. Patient with Life expectancy more than six months
- •9. Serum pregnancy test at screening and urine pregnancy test on Day 1(before dosing) of each cycle must be negative.
- •10. Male or Female patients or their partner must agree to use effective measures of contraception during the study.
- •(It is investigatorâ??s responsibility to ensure that above points regarding an effective
- •method of avoiding pregnancy are discussed with patient in detail and patient agreed
- •for this and it is documented in source document. The investigator should ensure that
- •the patient is using an effective method of avoiding pregnancy as per protocol.)
排除标准
- •1. Patient with the history of hypersensitivity reactions to Taxanes or any other component of formulation.
- •2. Chronic treatment with systemic steroids or another immunosuppressive agent or patient with severely immunocompromised state.
- •3. Patients with an active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections).
- •4. Major surgery within 4 weeks prior to dosing or planned major surgery.
- •5. Patient treated with radiotherapy/and adjuvant chemotherapy within 30 days prior to screening
- •6. Patient with known CNS lesions (brain metastasis or carcinomatous meningitis).
- •7. Any history or presence of clinically significant cardiovascular, respiratory, hepatic,renal, hematologic, gastrointestinal, endocrine, immunologic,dermatologic,neurologic, or psychiatric disease or any other condition which in the opinion of the investigator could jeopardize the safety of the subject or the validity of the study results.
- •8. Patients with hepatitis B or hepatitis C infection or known case of HIV infection.
- •9. Pregnant or breast-feeding patients.
- •10. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 as defined by NCI CTCAE 4.03 criteria.
研究者
相似试验
尚未招募
3 期
A randomized, multicentril, open label, comparative efficacy study in healthy child.CTRI/2022/01/039575Zydus Wellness Products Limited
招募中
2 期
Role and effect of Capsule HRPT-091514 as an add treatment to normal standard treatment in patient with chronic kidney disease.CTRI/2020/12/029519The Himalaya Drug Company
尚未招募
3 期
controlled trial of SHIRO KLOMAN treatment in mild to moderate symptomatic patients with SARS-CoV-2 Infection (Covid-19).CTRI/2021/09/036100Bindi Prashant Shah
已完成
4 期
A multicenter, two arm, randomized, open label clinical study investigating renal function in an advagraf®-based immunosupressive regimen with or without sirolimus in kidney transplant subjects.Kidney transplantationtransfer of a healthy kidney in another body with non-functioning kidneys.10029149NL-OMON38063Astellas Pharma B.V.30
进行中（未招募）
不适用
A multicenter, two arms, randomized, open label clinical Phase IV study investigating the proportion of CMV seropositive kidney transplant recipients who will develop a CMV infection within the first 6 months post-transplantation when treated with an immunosuppressive regimen including everolimus (Certican®) and reduced dose of cyclosporine A (Néoral®) versus an immunosuppressive regimen with mycophenolic acid (Myfortic®) and standard dose of cyclosporine A (Néoral®). - EVERCMVCMV infection in CMV-seropositive de novo kidney transplant recipients receiving an immunosuppressive regimen.EUCTR2013-003195-12-FRCHU de Bordeaux