EUCTR2013-001323-38-DE进行中（未招募）1 期
A randomized, open-label, parallel group, multi-center Phase II clinicaltrial evaluating effect of addition of DCVAC/OvCa to standardchemotherapy (carboplatin and gemcitabine) in women with relapsedplatinum sensitive epithelial ovarian carcinoma
SOTIO a.s.0 个研究点目标入组 60 人开始时间: 2013年7月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- Female
入选标准
- •1.Female aged =18 years
- •2.Patients with histologically confirmed, FIGO (Féderation Internationale de Gynécologie et d’Obstétrique) stage III and IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous), who had complete remission after first line platinum (Pt) based chemotherapy and are selected to receive second line Standard of Care chemotherapy
- •3.Radiologically confirmed relapse after >6 months of remission
- •(Pt-sensitive patients), found up to 4 weeks prior study entry.
- •4.The patient must have at least one measureable target lesion as defined by the RECIST 1.1 criteria to be eligible for enrolment in the study
- •5.Laboratory criteria (results must be obtained <14 days before randomization, including results obtained before giving informed consent):
- •?White blood cells (WBC) >4,000/mm3 (4.0 x109/L)
- •?Neutrophil count >1,500/mm3 (1.5 x109/L)
- •?Hemoglobin (Hb) =10g/dL (100g/L)
- •?Platelet count =100,000/mm3 (100 x109/L)
- •?Total bilirubin within normal limits (benign hereditary hyperbilirubinaemias, e.g. Gilbert´s syndrome are permitted)
- •?Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2x upper limit of normal (ULN), serum creatinine =2.0mg/dL
- •?Blood Urea Nitrogen (BUN) <2.0x ULN
- •6.Adequate coagulation parameters (results must be obtained <14 days before randomization, including results obtained before giving informed consent):
- •?Activated partial thromboplastin time (APTT) =1.5x ULN and
- •?International Normalized Ratio (INR) =1.5
- •7.Life expectancy of at least 12 months based on Investigator’s judgment
- •8.Eastern Cooperative Oncology Group (ECOG) Performance status 0?2
- •9.Signed informed consent including patient’s ability to comprehend its contents
- •10.Females of childbearing potential (assessed by Investigator) must have had a negative serum pregnancy test at screening (ß human chorionic gonadotropin [ß-HCG])
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.FIGO I,II epithelial ovarian cancer
- •2.FIGO III, IV clear cells epithelial ovarian cancer
- •3.Non-epithelial ovarian cancer
- •4.Borderline tumors (tumors of low malignant potential)
- •5.Prior or current systemic anti-cancer therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor [VEGF] therapy or hormonal therapy) except first line Pt based chemotherapy (with or without bevacizumab)
- •6.Previous or concurrent radiotherapy to the abdomen and pelvis
- •7.Malignancy other than epithelial ovarian cancer, except those that have been in CR for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas
- •8.Patient co-morbidities:
- •?Human immunodeficiency virus (HIV) positive, human T lymphotropic virus (HTLV) positive
- •?Active hepatitis B (HBV), active hepatitis C (HCV), active syphilis
- •?Evidence of active bacterial, viral or fungal infection requiring systemic treatment
- •?Clinically significant cardiovascular disease including:
- •?Symptomatic congestive heart failure
- •?Unstable angina pectoris
- •?Serious cardiac arrhythmia requiring medication
- •?Uncontrolled hypertension
- •?Myocardial infarction or ventricular arrhythmia or stroke within a 6 month period before inclusion, ejection fraction (EF) <40% or serious cardiac conduction system disorders, if a pacemaker is not present
- •?Pericardial effusion of any National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) grade
- •?Peripheral neuropathy having a CTCAE =Grade 2
- •?Active autoimmune disease requiring treatment
- •?History of severe forms of primary immune deficiencies
- •?History or anaphylaxis or other serious reaction following vaccination
- •?Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator’s opinion, would prevent participation in the trial
- •9.Known hypersensitivity to any constituent in the DCVAC/OvCa
- •10.Systemic immunosuppressive therapy for any reason
- •11.Refusal to sign the informed consent
- •12.Participation in a clinical trial using experimental therapy within the last 4 weeks before study entry; patients previously enrolled in protocol SOV01 who did not receive treatment with DCVAC/OvCa can be included in this study
- •13.Fertile woman of childbearing potential not willing to use highly effective method of contraception or combination of methods resulting into PEARL Index < 1 (implants, injectables, combination of oral contraceptives with intrauterine devices or barrier method of contraception or spermicidal jelly, vasectomized / sterilized partner or sexual abstinence) for the study duration and at least six months afterwards
- •14.Pregnant or lactating women
研究者
相似试验
进行中（未招募）
1 期
Evaluation and efficacy and safety of DCVAC/OvCa (therapeutic ovarian cancer vaccine) in woman with relapsed platinum resistant epithelial ovarian carcinomaepithelial ovarian carcinomaMedDRA version: 16.0Level: PTClassification code 10061328Term: Ovarian epithelial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-001325-24-CZSOTIO a.s.60
进行中（未招募）
1 期
Evaluation and efficacy and safety of DCVAC/OvCa (ovarian cancerimmunotherapy) in woman with relapsed platinum resistant epithelial ovarian carcinomaEUCTR2013-001325-24-PLSOTIO a.s.60
进行中（未招募）
1 期
Evaluation of efficacy and safety of DCVAC/OvCa (therapeutic ovarian cancer vaccine) in women with relapsed platinum sensitive ovarian carcinomaEUCTR2013-001323-38-PLSOTIO a.s.60
进行中（未招募）
1 期
Evaluation of efficacy and safety of DCVAC/OvCa (therapeutic ovarian cancer vaccine) in women with relapsed platinum sensitive ovarian carcinomaepithelial ovarian carcinomaMedDRA version: 19.0Level: PTClassification code 10061328Term: Ovarian epithelial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-001323-38-CZSOTIO a.s.60
进行中（未招募）
1 期
Evaluation and efficacy and safety of DCVAC/OvCa (therapeutic ovarian cancer vaccine) in woman with relapsed platinum resistant epithelial ovarian carcinomaepithelial ovarian carcinomaMedDRA version: 18.0Level: PTClassification code 10061328Term: Ovarian epithelial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-001325-24-DESOTIO a.s.60