EUCTR2014-000489-23-BG进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of CF102 in the Second-Line Treatment of Advanced Hepatocellular Carcinoma in Subjects with Child-Pugh Class B Cirrhosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Males and females at least 18 years of age.
- •2.Diagnosis of HCC:
- •For subjects without underlying cirrhosis at the time of diagnosis, diagnosis of HCC documented by cytology and/or histology.
- •For subjects with underlying cirrhosis at the time of diagnosis, diagnosis of HCC established according to the American Association for the Study of Liver Diseases Practice Guideline algorithm (Appendix E).
- •3.HCC is advanced, ie, treatment-refractory or metastatic, and no standard therapies are expected to be curative.
- •4.Receipt of prior sorafenib therapy for at least 3 weeks and withdrawal from treatment due either to intolerability or to radiographic evidence of disease progression. If treatment was withdrawn due to intolerability manifested as a Grade 3 or 4 event by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE v4.0), less than 3 weeks of continuous prior administration prior to withdrawal is acceptable (see also Exclusion Criterion #3).
- •5.Prior sorafenib treatment was discontinued for at least 2 weeks prior to the Baseline Visit.
- •6.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of = 2 (Appendix B).
- •7.Cirrhosis classified as Child-Pugh Class B (Appendix C).
- •8.The following laboratory values must be documented within 3 days prior to the first dose of study drug:
- •Absolute neutrophil count (ANC) ? 1.5 × 109/L
- •Platelet count ? 75 × 109/L
- •Serum creatinine ? 2.0 mg/dL
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 5 × the upper limit of normal (ULN)
- •Total bilirubin = 3.0 mg/dL
- •Serum albumin = 2.8 g/dL
- •Prothrombin time (PT) no greater than 6 seconds longer than control.
- •9.Life expectancy of = 6 weeks.
- •10.For women of childbearing potential, negative serum pregnancy test result.
- •11.Provide written informed consent to participate.
- •12.Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other trial related procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 39
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 39
排除标准
- •1.Receipt of no, or of > 1, prior systemic drug therapies for HCC.
- •2.Receipt of systemic cancer therapy, immunomodulatory drug therapy, immunosuppressive therapy, or corticosteroids > 20 mg/day prednisone or equivalent within 14 days prior to the Baseline Visit or concurrently during the trial.
- •3.Presence of an acute or chronic toxicity of prior chemotherapy that has not resolved to = Grade 1, as determined by CTCAE v 4.0.
- •4.Locoregional treatment within 4 weeks prior to the Baseline Visit.
- •5.Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.
- •6.Use of any investigational agent within 4 weeks prior to the Baseline Visit.
- •7.Child-Pugh Class A or C cirrhosis, or hepatic encephalopathy.
- •8.Occurrence of esophageal or other gastrointestinal hemorrhage requiring transfusion within 4 weeks prior to the Baseline Visit.
- •9. Uncontrolled or clinically unstable thyroid disease, per judgement of the Principal Investigator.
- •10.Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.
- •11.Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
- •12.Liver transplant.
- •13.Active malignancy other than HCC.
- •14.Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4) (Appendix B).
- •15.Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
- •16.History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to > 450 msec for males or > 470 msec for females.
- •17.Pregnant or lactating female.
- •18.Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Investigator, are effective and adequate for the subject’s circumstances while on study drug.
- •19.Men who partner with a woman of childbearing potential, unless they agree to use effective, dual contraceptive methods (ie, a condom, with female partner using oral, injectable, or barrier method) while on study drug and for 3 months afterward.
- •20.Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or study drug administration; may interfere with the informed consent process and/or with compliance with the requirements of the trial; or may interfere with the interpretation of trial results and, in the Investigator’s opinion, would make the subject inappropriate for entry into this trial.
研究者
相似试验
进行中（未招募）
1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects with Idiopathic Detrusor OveractivityIdiopathic Detrusor Overactivity (Overactive Bladder)EUCTR2005-005868-93-GBAVERA PHARMACEUTICALS INC.62
进行中（未招募）
1 期
A study to assess the safety and effectiveness of enzalutamide in patients with advanced hepatocellular carcinomaMale and female subjects with HCC of any etiology who have progressed on or were intolerant to sorafenib or other anti-VEGF therapy in the advanced settingMedDRA version: 18.1Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-004283-37-ESAstellas Pharma Global Development, Inc.165
进行中（未招募）
1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects with Idiopathic Detrusor OveractivityIdiaopathic Detrusor Overactivity (Overactive Bladder)EUCTR2005-005868-93-NLAVERA PHARMACEUTICALS INC.62
进行中（未招募）
1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of BIO89-100 in Subjects with Severe HypertriglyceridemiaSevere Hypertriglyceridemia (SHTG)MedDRA version: 20.1Level: LLTClassification code 10020870Term: HypertriglyceridemiaSystem Organ Class: 100000004861EUCTR2020-000641-13-HU89bio, Inc.90
进行中（未招募）
1 期
A study to test the efficacy and safety of the drug INCB054707 on a skin condition called Prurigo NodularisPrurigo NodularisMedDRA version: 20.0Level: LLTClassification code 10037084Term: Prurigo nodularisSystem Organ Class: 100000004858EUCTR2021-006329-23-ESIncyte Corporation140