KCT0003710已完成未知
Multi-center, Open-label, Phase 1b Clinical Trial to Evaluate the Safety, Tolerability, and Exploratory Efficacy of TEW-7197 in Combination with FOLFOX in Patients with Metastatic Pancreatic Ductal Adenocarcinoma who have Failed First-Line Gemcitabine and nab-Paclitaxel
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1)Subjects who are males or females = 19 years of age
- •2)Subjects who have the following history of first-line gemcitabine and nab-paclitaxel among patients with cytologically or histologically proven metastatic pancreatic ductal adenocarcinoma
- •3)Subjects who can give written informed consent for participation in this trial after receiving explanations of this trial
- •4)Subjects who have the following laboratory test values:
- •-bilirubin = 1.5 x ULN (upper limit of normal)
- •-aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 5 x ULN
- •-serum creatinine = 1.5 x ULNor estimated creatinine clearance = 40 mL/min (Cockcroft-Gault)
- •-partial thromboplastin time (aPTT) = 1.5 x ULN
- •-absolute neutrophil count (ANC) = 1,500 cells/µL
- •-platelet count = 100,000/µL
- •-hemoglobin = 9.0 g/dL
- •5)Subjects who have at least a 12-week life expectancy at the Investigator’s discretion
- •6)Subjects who have Eastern Cooperative Oncology Group (ECOG)Performance Status 0-1
排除标准
- •1)Subjects who were treated with surgery, radiotherapy, chemotherapy or investigational therapy within 2 weeks (note: placement of biliary stent is allowed)
- •2)Subjects who have uncontrolled CNS metastases (patients who require steroids should be on a stable or decreasing dose for at least 2 weeks)
- •3)Subjects who have any contraindications for 5-FU, leucovorin, or oxaliplatin
- •4)Subjects who have moderate or severe cardiovascular disease
- •-Subjects who have myocardial infarction, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension within 6 months before screening
- •-Subjects who have major abnormalities at the Investigator’s discretion based on electrocardiogram (ECG)and Doppler ECHO results at screening or within 14 days before screening
- •-Subjects who have increase in brain natriuretic peptide(BNP) or increase in troponin (over 99th percentile upper reference limit) at Screening (based on the normal range of relevant study center)
- •-Subjects who have risk factors for ascending aortic aneurysm such as genetic disorder and trauma and risk factors for aortic stenosis
- •-Subjects who have a history of heart or aorta surgery
- •5)Subjects who have clinically significant gastrointestinal bleeding within 4 weeks before screening
- •6)Subjects who have a known history or suspected hypersensitivity to any excipients of the investigational product or combination drug(s)
- •7)Subjects who have received prior treatment targeting the signaling pathway of TGF-ß
- •8)Subjects who have a disease or condition that affects the mechanism of the investigational product, or are currently using or planning to use:
- •-Drugs that are exclusively or primarily eliminated by cytochrome P-450 isozyme (CYP) including CYP1A2, CYP2B6, or CYP3A4
- •-Drugs that are exclusively or primarily eliminated by UDP glucuronyltransferase (UGT) 1A1 (UGT1A1)
- •-Drugs that are substrates for the drug transporter multidrug resistance protein 1 (MDR1) have a narrow therapeutic window or are strong inhibitors of drug transporter MDR1
- •-Drugs that are strong inhibitors or inducers of CYP2D6 or CYP3A4
- •9)Subjects who are unable to swallow tablets
- •10)Subjects who have a history of or are suspected of drug abuse
- •11)Female subjects of child-bearing potential who have a positive result on a pregnancy test at screening or are unable to agree to use an effective barrier method of birth control to avoid pregnancy during the study period (e.g., sterilization, intrauterine contraceptive device, combination of oral contraception and barrier contraception, combination of other hormone delivery systems and barrier contraception, contraceptive cream, combination of cream, jelly, or form and diaphragm or condom)
- •12)Subjects, in the opinion of the Investigator, who are unsuitable to participate in the study
- •13)Subjects who were treated with other investigational products within 28 days before screening or within a period shorter than 5-timesthe half-life of the investigational product
研究者
相似试验
尚未招募
不适用
to evaluate safety, tolerance and efficacy of TASO(TGF-b2 targeting anti-sense oligonucleotide)-001 in combination with recombinant interleukin-2(Aldesleukin) in patients with solid tumorNeoplasmsKCT0006200Autotelic bio9
进行中（未招募）
1 期
Clinical Trial to evaluate the efficacy and safety of Niraparib + Endocrin Therapy in luminal metastatic breast cancer patients.Advanced or metastatic HR-positive/HER2-negative breast cancer inpatients harboring either gBRCAms or gBRCAwt and HRD.MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864MedDRA version: 20.1Level: PTClassification code 10077481Term: Human epidermal growth factor receptor negativeSystem Organ Class: 10022891 - InvestigationsEUCTR2017-004323-72-ESMedica Scientia Innovation Research (MedSIR)23
进行中（未招募）
1 期
Study evaluating the safety and activity of cevostamab (BFCR4350A) given by subcutaneous injection in patients with relapsed or refractory multiple myelomaCancerMultiple myelomaISRCTN26168155Genentech Inc.170
未知
1 期
Phase I/II Multicenter, Open-label Trial to Evaluate the Safety and Pharmacokinetics of Alpha-1 MP in Patients with Alpha1-Antitrypsin DeficiencyAlpha1-antitrypsin deficiencyJPRN-jRCT2080223105Grifols Japan K.K.3
进行中（未招募）
1 期
An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic profile of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in non-curable patients with SCCHN - Zalutumumab PK in SCCHon-Curable Squamous cell carcinoma of the head and neck (SCCHN)MedDRA version: 12.0Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckEUCTR2009-013317-10-BEGenmab A/S26