JPRN-jRCT2080221445未知1 期
Phase 1, Open Label Study to Assess the Safety and Tolerability of U3-1565 in Japanese Subjects with Advanced Solid Malignant Tumors
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 44 人开始时间: 2011年4月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 44
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
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1) Histologically or cytologically confirmed advanced solid malignant tumor.
- •2) Refractory to standard treatment or for which no standard treatment is available.
- •3) Men or women at the age of 20-75 years (at informed consent).
- •4) ECOG Performance Status (PS) =< 1.
- •5) Preserved organ function as defined below within 7 days prior to registration.
- •WBC : 3000/microL, ANC : >= 1500/microL, Platelet count: >= 100000/microL,
- •Hb : >= 9.0 g/dL, AST: =< 3 x upper limit of normal (ULN)*, ALT : =< 3 x ULN*, Total bilirubin : =< 1.5 x ULN, Creatinine : =< 1.5 x ULN or creatinine clearance >= 60 ml/min, PT or PTT : =< 1.5 x ULN
- •* If liver metastases are present, >= 5 x ULN
- •6) Recovered or resolved to baseline values (before prior therapy) from toxicities of prior anti-cancer therapies (chemotherapy , hormonal treatment, radiation, and/or surgery). Except alopecia, skin toxicity (Grade 1), peripheral neurotoxicity (Grade 1) and fatigue (Grade 1). Graded according to CTCAE v 4.0 Japanese version.
- •7) Following treatment-free period prior to first administration of study drug :
- •i) Surgery (laparotomy, thoracotomy) : 4 weeks (2 weeks for less invasive surgery, such as colostomy)
- •ii) Radiation : 4 weeks (2 weeks for the irradiation to bone metastases (except for pelvic irradiation), and brain metastasis for pain releiefs)
- •iii) Chemotherapy (including antibody) : 4 weeks (6 weeks for nitrosourea antineoplastic agent and mitomycin C)
- •iv) Hormonal treatment: 4 weeks
- •v) Pleurodesis : 2 weeks
- •8) Life expectancy >=3 months.
排除标准
- •1) History of any of the following disease within 6 months before enrollment or complication, as follows :
- •Cardiac failure (NYHA>=ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requires treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, deep-vein thrombosis or clinically severe thromboembolic event, clinically severe pulmonary disease (eg, chronic obstructive pulmonary disease, asthma)
- •2) Any of the complication, as follows :
- •i) Clinically severe infection that requires systemic administration of antibacterial or antiviral agents.
- •ii) Chronic diarrhea, inflammatory bowel disease (e.g., ulcerative colitis, crohn disease) or partial bowel obstruction.
- •iii) Fluid retention that requires treatment (e.g., pleural effusions, pericardial effusions, ascites).
- •iv) Uncontrolled diabetes despite any medication.
- •v) Uncontrolled hypertension despite any medication.
- •vi) Uncontrolled psychiatric symptoms despite any medication.
- •vii) Any concomitant medical condition that could interfere completion of protocol.
- •3) Suspicion of having interstitial pneumonia or pulmonary fibrosis by radiological examination (Chest CT-scan), or history of pulmonary disease (e.g., radiation pneumonia, drug induced pneumonia).
- •4) Cardiac dysfunction that considered to require treatment identified by echocardiography.
- •5) Mean QTc intervals> 450 msec for male subjects and > 470 msec for female subjects based on screening ECG.
- •6) Clinically active brain metastases defined as symptomatic or requiring treatment.
- •7) History of hematopoietic stem cell or bone marrow transplant.
- •8) Have a serious, nonhealing wound or unhealed bone fracture.
- •9) History of HBs antigen positivity, HCV antibody positivity or HIV antibody positivity
- •10) Active gastrointestinal hemorrhage that requires blood transfusions within 2 weeks.
- •11) History of severe drug sensitivity (e.g., anaphylactoid symptoms) that seriously interfere with study objectives.
- •12) Treatment with an investigational drug within 4 weeks before enrollment.
- •13) History of critical hypersensitivity to a polysorbate 20 content formulation .
- •14) Female subject with pregnancy (confirmed by pregnancy test) and lactation.
- •15) Unwilling to use adequate contraceptive methods during the study period and 6 months following the last study drug administration.
研究者
相似试验
未知
1 期
Phase 1 study of DS-5573aAdvanced solid malignant tumors refractory to standard treatment or for which no standard treatment is available.JPRN-jRCT2080222535DAIICHISANKYO Co.,Ltd.57
已完成
1 期
A clinical study to assess the safety, tolerability & immunogenicity of Measles Rubella(MR) vaccine in 4 to 5 years old healthy children.CTRI/2022/03/040874Biological E Limited24
已完成
1 期
A Phase 1 Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Selumetinib, a Selective Mitogen Activated Protein Kinase Kinase (MEK) 1 Inhibitor, in Japanese Paediatric Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable and Symptomatic Plexiform Neurofibromas (PN)JPRN-jRCT2080225326AstraZeneca KK9
已完成
1 期
A Phase 1, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti- tumor Activity of AZD9833 in Japanese Women with ER Positive, HER2 Negative Advanced Breast CancerAdvanced Breast CancerJPRN-jRCT2080225373AstraZeneca KK12
进行中（未招募）
1 期
An Open-Label Phase 1 Study of Ceralasertib in Japanese Patients with Advanced Solid MalignanciesAdvanced solid malignanciesJPRN-jRCT2031220106Yamaji Shigeyuki18