CTRI/2009/091/000214已完成1 期
A Phase I/II study to evaluate safety and efficacy of P276-00 in combination with Gemcitabine in patients with cancer of pancreas (Acronym: SAVIOR).
Piramal Life Sciences Limited0 个研究点目标入组 23 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
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. Histologically or cytologically confirmed diagnosis of infiltrating ductal adenocarcinoma of pancreas. 2. Chemonaive patients i.e. patients must not have received chemotherapy or biologic/targeted anticancer therapy for the adenocarcinoma of pancreas. 3.Locally advanced inoperable pancreatic cancer. 4. Patients of either sex, aged > or = 18 years.5. Karnofsky performance status of > or = 60%. 6. Adequate bone marrow reserve: white blood cell (WBC) count > or = 4 x 109/l, Absolute neutrophil count (ANC) > or = 1.5 x 109/l, platelets > or =100 x 109/l, hemoglobin > or = 10 g/dl.7. Adequate liver function: bilirubin < or = 1.5 times the upper normal value, ALT/AST/ alkaline phosphatase less than 3 times the upper normal value (unless due to liver metastases in which case bilirubin less than 3 times the upper normal value, ALT/AST less than 4 times the upper normal value, and alkaline phosphatase without limit). 8. Adequate renal function: creatinine < or = 1.5 times the upper normal value.9. If female a)Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of at least 2 approved contraceptive methods (at least one should be a barrier method) during and for 4 weeks after stopping the study treatment. b) Negative urine beta HCG test within 1 week prior to protocol entry where childbearing potential is not terminated.10. Additional inclusion criterion only for part B: Patient should satisfy at least one of the following criteria on cycle 1 day 1:a) Karnofsky performance status of 60 or 70 b)Baseline analgesic consumption of > or = 10 morphine equivalent per day c) Baseline pain intensity score of > or = 20 mm
排除标准
- •1. Inability / unwillingness to give consent
- •2. Pregnant or breast feeding women
- •3. Brain metastasis (active or inactive)
- •4. Serious concomitant systemic disorders including, but not limited to active infection, congestive heart failure, cardiac arrhythmia, psychiatric illness etc that are incompatible with the study (at the discretion of the investigator)
- •5.Patients known to be suffering from infection with HIV,Tuberculosis,Hepatitis C or Hepatitis B.
- •6. Patients who had received any other investigational drug within 1 month prior to Day 1 of protocol treatment or who have not recovered (to grade 1) from adverse effects of the investigational agent received prior to this period.
- •7. Patients with QTc 450 msec on 12-lead standard electrocardiogram (ECG)
- •8. Major surgery within 2 weeks prior to protocol
- •9. Radiotherapy to 10% of bone marrow
- •10. Patients with clinically significant 3rd space fluid
- •1.accumulation (ascites, pleural effusion)
研究者
相似试验
进行中（未招募）
1 期
Evaluation of safety and efficacy of DCVAC/LuCa (immunotherapy of lung cancer) in patients with metastatic lung cancerStage IV Non-Small Cell Lung CancerMedDRA version: 20.1Level: PTClassification code 10025070Term: Lung carcinoma cell type unspecified stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-003084-37-CZSOTIO a.s.98
进行中（未招募）
1 期
Evaluation of safety and efficacy of DCVAC/LuCa (immunotherapy of lung cancer) in patients with metastatic lung cancerStage IV Non-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10025070Term: Lung carcinoma cell type unspecified stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-003084-37-SKSOTIO a.s.98
进行中（未招募）
1 期
Gene therapy study with autologous hemapoietic stem cells for patients affected by MPSIHEUCTR2017-002430-23-ITOSPEDALE SAN RAFFAELE6
进行中（未招募）
1 期
Gene therapy study with autologous hemapoietic stem cells for patients affected by MPSIHMucopolysaccharidosis type I HurlerCTIS2024-514870-29-00Ospedale San Raffaele S.r.l.8
进行中（未招募）
1 期
Studio di terapia genica con cellule staminali ematopoietiche autologheEUCTR2014-004860-39-ITOSPEDALE SAN RAFFAELE10