EUCTR2017-004058-40-IT进行中（未招募）1 期
A multicentre, open-label, three-arm randomised Phase II trial assessing the safety and efficacy of the HSP90 inhibitor Ganetespib in combination with Carboplatin followed by maintenance treatment with Niraparib versus Ganetespib plus Carboplatin followed by Ganetespib and Niraparib versus Carboplatin in combination with standard chemotherapy followed by Niraparib maintenance treatment in platinum-sensitive ovarian cancer patients - EUDARIO: European Trial on enhanced DNA Repair Inhibition in Ovarian Cancer
IVERSITé CATHOLIQUE DE LOUVAI0 个研究点目标入组 122 人开始时间: 2020年11月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 122
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
- •Ability to understand and willingness to sign and date a written informed consent document
- •Female patients = 18 year of age
- •High-grade serous, high grade endometrioid, undifferentiated epithelial ovarian, or carcinosarcoma, fallopian tube or primary peritoneal cancer
- •Platinum-sensitive relapse > 6 months after previous platinum-based treatment (calculated from the first day of the last cycle of the last platinum based chemotherapy until the date of progression confirmed according to RECIST 1.1 on imaging)
- •No limits in number of prior treatment lines
- •Measurable or evaluable disease according to RECIST 1.1
- •ECOG performance status 0-1
- •Adequate functions of the bone marrow: o Platelets = 100 x 109/L o Absolute neutrophil count (ANC) = 1.5 x 109/L
- •Adequate function of the organs: o Creatinine < 2 mg/dl (<177 µmol/L) o Total bilirubin = 1.5 x upper limit of normal (= 2.0 in patients with known Gilberts syndrome) OR direct bilirubin = 1 x ULN o SGOT/SGPT (AST/ALT) = 2.5 x upper limit of normal unless liver metastases are present, in which case they must be = 5 x ULN o Urinanalysis or urine dipstick for proteinuria less than 2+. Patients with = 2+ on dipstick should undergo 24-hour urine collection and must demonstrate < 1 g of protein/24 hours; except the proteinuria is clearly related to a catheter in the urinary system.
- •Adequate coagulation parameter: aPTT = 1.5 x ULN (patients on heparin treatment must have an aPTT between 1.5-2.5 x ULN), or INR = 1.5. (In patients receiving anticoagulants (such as warfarin) INR must be between 2.0 and 3.0 in two consecutive measurements 1-4 days apart).
- •Participant receiving corticosteroids (dose < 10 mg/day methylprednisolone equivalent), including inhaled steroids, may continue as long as their dose is stable for at least 4 weeks prior to initiating protocol therapy.
- •Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
- •Female participant has a negative serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of nonchildbearing potential.
- •Participant must agree to not breastfeed (or store breast milk for use) during the study or for 180 days afer the last dose of study treatment.
- •Haemoglobin =8.5 g/dl (patients may not receive a transfusion within 4 weeks prior to initiating study treatment)
- •Able to take oral medications
- •Availability of archival ovarian cancer tissue from primary diagnosis (delivery of FFPE block or slides is prerequisite for randomisation)
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Ovarian tumours with low malignant potential (i.e. borderline tumours)
- •Any prior radiotherapy to the pelvis or abdomen, or any radiotherapy encompassing > 20 % of the bone marrow within 2 weeks, or any radiotherapy within 1 week prior to Day 1 of protocol therapy.
- •Surgery (including open biopsy and traumatic injury) within 4 weeks prior to first dose of Ganetespib, or anticipation of the need for major surgery during study treatment • Minor surgical procedures, within 24 hours prior to the first study treatment
- •Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- •Any serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection.
- •Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (> 325 mg/day).
- •Patients with a history of diagnosis, detection or treatment of any prior malignancies = 2 years prior to initiating protocol therapy, except: basal or squamous cell carcinoma of the skin and cervical cancer that has been definitively treated.
- •Clinically significant gastro-intestinal (GI) tract abnormalities that may increase the risk for GI bleeding and / or perforation
- •Non-healing wound or non-healing bone fracture
- •Patients with symptomatic brain or leptomeningeal metastases (patients who are asyptomatic since treatment of brain or leptomeningeal metastases, eg after irradiation, are eligible)
- •Left ventricular ejection fraction (LVEF) defined by ECHO below the institutional lower limit of normal
- •Cerebrovascular accident (CVA)/ stroke or transient ischemic attack (TIA) or sub-arachnoid haemorrhage within = 6 months prior to first study treatment.
- •Significant cardiac disease: New Yourk Heart Assiciation (NYHA) Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary atrial or ventricular cardiac arrhythmias
- •History of prolonged QT syndrome, or family member with prolonged QT syndrome
- •QTc interval > 470 msec when 3 consecutive ECG values are averaged
- •Ventricular tachycardia or a supraventricular tachycardia that requires treatment with a Class Ia antiarrhythmic drug (e.g. sotalol, amiodarone, dofetilide). Use of other antiarrhythmic drugs is permitted • Second- or third-degree atrioventricular (AV) block, except: treated with a permanent pacemaker
- •Complete left bundle branch block (LBBB) • History of evidence of haemorrhagic disorders, patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorders, coagulopathy or tumour involving major vessels.
- •Participation in another clinical study with experimental therapy within 28 days before start of treatment.
- •Participant must not be simultaneously enrolled in any interventional clinical trial.
- •Women who are pregnant or are lactating • Patients unable to be regularly followed for any reason (geographic, familiar, social, psychologic, housed in an institution eg. prison because of a court agreement or administrative order)
- •Subjects that are dependent on the sponsor/CRO or investigational site as well as on the investigator.
- •History of known hypersensibility against any medication used in the study
- •Intolerance / Hypersensitivity reactions to components and exipients of study drugs
- •Peripheral neuropathy of grade >2 per NCI CTCAE, version 4.03, within 4 weeks prior to randomisation
- •Any other conditio
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