EUCTR2013-001325-24-PL进行中（未招募）1 期
A randomized, open-label, parallel group, multi-center Phase II clinical trial evaluating effect of addition of DCVAC/OvCa to standard chemotherapy in women with relapsed platinum resistant epithelial ovarian carcinoma
SOTIO a.s.0 个研究点目标入组 60 人开始时间: 2013年9月30日最近更新:
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 have undergone initial or interval debulking surgery
- •but have not reached complete remission of more than 6 months after
- •first line Platinum (Pt) based chemotherapy, for one of the following
- •? Patients are Pt-refractory (no response)
- •? Complete remission was not reached (partial responders)
- •? Relapse within =6 months of remission (Pt-resistant)
- •3. Pt-based chemotherapy failure should have been confirmed by
- •computerized tomography (CT)/magnetic resonance imaging (MRI)
- •scan (Pt-resistant) or by finding described as 'did not reach complete
- •clinical remission' (Pt-refractory or Pt-partial response). Patients are
- •selected to receive second line Standard of Care chemotherapy
- •4. Patients must have at least one measureable target lesion as defined
- •the RECIST 1.1 criteria
- •5. Laboratory criteria (results must be obtained <14 days before
- •randomization, including results obtained before giving informed
- •? White blood cells (WBC) >4,000/mm3 (4.0 x109/L)
- •? Neutrophil count >1,500/mm3 (1.5 x109/L)
- •? Hemoglobin of at least 10g/dL (100g/L)
- •? Platelet count of at least 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 Investigators
- •8. Eastern Cooperative Oncology Group (ECOG) Performance status 0?2
- •9. Signed informed consent including patient's ability to comprehend its
- •10. Females of childbearing potential (assessed by Investigator) must
- •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
- •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
- •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
- •? 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
- •? Pleural and pericardial effusion of any National Cancer Institute
- •(NCI) common terminology criteria for adverse events (CTCAE)
- •? 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
- 另有 3 项未显示
研究者
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