EUCTR2013-001276-38-GB进行中（未招募）不适用
A Clinical Study Of ColoAd1 Administered Intraperitoneally: Dose Finding and Proof of Concept in Platinum-Resistant Epithelial Ovarian Cancer
PsiOxus Therapeutics Ltd0 个研究点目标入组 47 人开始时间: 2013年10月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 47
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. Able and willing to provide written informed consent and to comply with the study protocol
- •2. Age = 18 years
- •3. Histologically confirmed non-resectable epithelial ovarian, fallopian tube or primary peritoneal cancer
- •4. Phase Ia and Phase Ib first 3 patients:
- •- Confirmed relapsed within the platinum-resistant time frame.
- •- Platinum-resistance is defined as progression within 6 months of receiving prior platinum-containing chemotherapy, with progression identified either by CT scanning (RECIST v1.1) or symptomatic CA125 progression (GCIG CA-125 criteria)
- •- The treatment immediately prior to study entry need not be platinum-based
- •- Absence of other available treatment option
- •Phase Ib (after first 3 patients) and Phase II
- •- Confirmed relapsed within the platinum-resistant time frame
- •- Platinum-resistance is defined as progression within 6 months of receiving prior platinum-containing chemotherapy, with progression identified either by CT scanning (RECIST v1.1) or symptomatic CA125 progression (GCIG CA-125 criteria)
- •- The treatment immediately prior to study entry need not be platinum-based
- •Phase Ia and Phase Ib first 3 patients:
- •- Evaluable disease (by RECIST v1.1).
- •Phase Ib (after first 3 patients) and Phase II:
- •- Measurable disease (by RECIST v1.1)
- •5. Able to undergo IP injection, including all administration procedures e.g. placement of IP catheter, iatrogenic ascites and ascites drainage and comply with study procedures in the Investigator’s opinion
- •6. Recovered to at least grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancy at time of first administration of enadenotucirev
- •7. ECOG Performance Status Score of 0 - 1
- •8. Adequate renal function
- •- Creatinine = 1.8 mg/dl (159 µmol/l) or calculated creatinine clearance using the Cockcroft-Gault formula = 45 ml/min, or measured creatinine clearance = 45 ml/min
- •- Absence of clinically significant haematuria on urinalysis: dipstick =2+
- •- Absence of clinically significant proteinuria on urinalysis: dipstick = 2+
- •9. Adequate hepatic function
- •- Serum bilirubin <1.5 x upper limit of normal (ULN)
- •- Aspartate transaminase (AST) and alanine transaminase (ALT) = 3 x ULN
- •10. Adequate bone marrow function:
- •- Absolute neutrophil count (ANC) = 1.5 x 10e9/l
- •- Platelets = 100 x 10e9/l
- •- Haemoglobin = 90 g/l
- •11. Adequate coagulation tests: INR = 1.5 x ULN;
- •12. Access to archival tumour samples
- •13. For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment
- •14. For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year (e.g. hormonal implants, combined oral contraceptives, vasectomised partner), during the treatment period and for at least 3 months after the last dose of study drug
- •15. For selected patients in the Phase Ia and Phase II part of the study participating in the exploratory assessment of tumour samples:
- •- Ovarian disease amenable to percutaneous image-guided biopsy.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1. Tumours of malignant mixed mesodermal (MMMT) or mucinous subtypes, or non-epithelial ovarian cancers (e.g. Brenner tumours, Sex-cord tumours)
- •2. Symptomatic sub-acute bowel obstruction, characterised by e.g. regular bloating, nausea, vomiting, constipation or diarrhoea
- •3. Pregnant or lactating (nursing) women
- •4. Known and/or a history or evidence of significant immunodeficiency due to underlying illness (e.g. human immunodeficiency virus [HIV]/acquired immunodeficiency syndrome [AIDS]) and/or medication (e.g. systemic corticosteroids at doses higher than dexamethasone 20 mg [or other corticosteroid equivalent to dexamethasone dose] for <= 14 days or prolonged administration [>14 days] of dexamethasone at doses higher than 10 mg but <=20 mg [or other corticosteroid equivalent to dexamethasone dose] or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 14 days)
- •5. Splenectomy
- •6. Prior allogeneic or autologous bone marrow or organ transplantation
- •7. Active infections requiring antibiotics, physician monitoring, or recurrent fevers >38.0degC associated with a clinical diagnosis of active infection
- •8. Active viral disease, positive serology for HIV, hepatitis B or hepatitis C
- •9. Use of the following anti-viral agents:
- •- Ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to day 1
- •- or pegylated interferon (PEG-IFN) (within 14 days prior to day 1)
- •10. Administration of an investigational drug within 28 days
- •11. Concurrent administration of any cancer therapy other than planned study treatment
- •12. Major surgery within 2 weeks prior to first dose of enadenotucirev
- •13. Phase Ib (after first 3 patients) and Phase II only: another primary malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ or in situ stage 1 synchronous endometrial cancer)
- •14. Symptomatic central nervous system (CNS) metastasis
- •15. Inflammatory diseases of the bowel
- •16. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease
- •17. Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the drug
- •18. Known allergy to treatment medication or its excipients
- •19. Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
研究者
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