EUCTR2017-001770-42-GB进行中（未招募）1 期
A multicenter phase II non-randomised trial assessing the efficacy of Domatinostat plus avelumab in patients with previously treated advanced mismatch repair proficient oesophagogastric and colorectal cancers - EMERGE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 83
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
- •i.Male/female patients aged =18 years
- •ii.Histologically confirmed gastric, gastro-oesophageal junction or oesophageal adenocarcinoma (referred to as oesophagogastric adenocarcinoma (OGA) in this protocol) or colorectal adenocarcinoma (referred to as CRC in this protocol)
- •iii.Agrees to undergo biopsies for translational endpoints
- •iv.Tumour must be mismatch repair proficient assessed using a validated test such as immunohistochemistry for mismatch repair proteins or microsatellite instability testing
- •v.Tumours should be advanced and inoperable or metastatic
- •vi.Patients must have received at least one prior chemotherapy treatment for their cancer, have no established treatment option, or decides against an established treatment option.
- •vii.Adequate bone marrow function:
- •a.Absolute neutrophil count (ANC) =1.5 x109/L
- •b.White blood count >3x109/L
- •c.Platelets =100x109/L
- •d.Haemoglobin (Hb) =9g/dl (can be post-transfusion)
- •viii.Adequate renal function: Creatinine Clearance o =30ml/min is required. This may be calculated as per local practice, if calculated CrCl is <60ml/min then EDTA is required to demonstrate CrCl of =30ml/min If available, the EDTA clearance should always take precedence over the creatinine clearance.
- •ix.Adequate liver function
- •a.Serum bilirubin =1.5x ULN
- •b.ALT/AST =2.5x ULN or ALT/AST =5x ULN if metastatic disease to liver
- •x.Adequate coagulation profile
- •a.International Normalised Ratio (INR) < 1.5
- •b.Activated Prothrombin Time (APTT) < 1.5xULN
- •xi.Patients on oral anticoagulation are advised to change to low molecular weight heparin prior to study entry to be eligible
- •xii.ECOG performance status 0-1
- •xiii.Patient is fit to undergo all protocol investigations and receive all protocol treatment based on the assessment oncology clinics
- •xiv.Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment.
- •xv.Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans
- •xvi. Pregnancy must be excluded with a negative serum pregnancy test, within 7 days before initiation of therapy, if the risk of conception exists. Sexually active female patients must be surgically sterile or be postmenopausal or must agree to use highly effective contraception which must be used for 10 days before the negative pregnancy test. Sexually active male patients must be surgically sterile or must agree to use highly effective contraception, i.e. methods with a failure rate of <1% per year (see section 6.4 for full definition and examples of highly effective contraception). Highly effective contraception must be agreed to be used throughout the study and for 3 monthsafter last avelumab treatment if risk of conception exists. Female patients of child-bearing potential should be strictly advised to use a highly effective contraceptive measure, from the time of screening to 3 months after the last dose of trial treatment. Male patients with partners of child bearing potential should be strictly advised to use barrier contraception in addition to having their partner use another method of contraception during the trial and for three months after the last dose. Male patients should also be advised to abstain from sexual intercourse with pregnant or lactating women, or to use condoms.
- •xvii) Measurable disease
排除标准
- •Patients are not eligible for the trial if any of the exclusion criteria below are met:
- •i.Any contraindication or known hypersensitivity reaction to any of the study drugs
- •ii.Persisting toxicity relating to prior therapy of >grade 1 CTCAE version 4.03 except alopecia of any grade and neuropathy = grade 2, or other grade =2 not constituting a safety risk based on investigators judgement
- •iii.Any prior treatment with immunotherapy including anti-PD-1or PD-L1 therapy or other immunomodulatory drugs.
- •iv.All subjects with brain metastases, except those meeting the following criteria:
- •a.Brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrolment
- •b.No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
- •c.Subjects must be either off steroids or on a stable or decreasing dose of <10mg daily prednisone (or equivalent)
- •v.Known severe hypersensitivity reactions to monoclonal antibodies (Grade = 3 NCI CTCAE v 4.0), any history of anaphylaxis, or uncontrolled asthma (i.e., 3 or more features of partially controlled asthma)
- •vi.Patients who have received chemotherapy or radiotherapy for a previous malignancy in the past 3 years.
- •vii.Any immunodeficiency disorder
- •viii.Any active, known or suspected autoimmune disease that might deteriorate when receiving immunostimulatory agent, with the following exceptions:
- •a.Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
- •b.Patients requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses =10mg (or equivalent) of prednisolone per day
- •c.Administration of steroids through a route known to result in minimal systemic exposure (topical, intranasal, intra-ocular, intra-articular or inhalation) are acceptable. Steroids as pre-medication for hypersensitivity reactions e.g. CT contrast are also acceptable.
- •ix.Prior organ transplantation, including allogeneic stem-cell transplantation
- •x.Active infection requiring systemic therapy
- •xi.History of inflammatory bowel disease
- •xii.Patients with a history of interstitial lung disease or radiological evidence of pulmonary fibrosis
- •xiii.Cerebrovascular disease (including transient ischaemic attacks (TIA) and strokes) within the previous 6 months
- •xiv. Cardiovascular diseases as follows:
- •a. Myocardial infarction within the previous 6 months
- •b. Unstable angina
- •c. Congestive heart failure =NYHA Classification Class II
- •d. Serious cardiac arrhythmia requiring medication (for example,
- •ventricular tachycardia, supraventricular tachycardia or atrial fibrillation with a resting heart rate > 110bpm)
- •e. Patients with a marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >450 msec (Grade 1 NCI-CTCAE); Long-QT-Syndrome (QTcF is applicable)
- •xv. Current signs or symptoms of any other severe progressive or uncontrolled hepatic, haematologic, gastrointestinal, endocrine, respiratory or cardiac disease, which in the opinion of the investigator, might impair the subject’s tolerance of trial treatment or procedures.
- •xvi.Major surgery, major trauma or open biopsy within 28 days prior to registration (not including staging laparoscopy)
- •xvii.Evidence of bleeding diathesis or
研究者
相似试验
进行中（未招募）
1 期
WaKING: Wnt and checKpoint INhibition in Gastric cancerPatients with advanced mismatch repair proficient oesophagogastric cancerMedDRA version: 21.1Level: LLTClassification code 10071114Term: Metastatic gastric adenocarcinomaSystem Organ Class: 100000004864EUCTR2018-004138-13-GBTHE ROYAL MARSDEN NHS FOUNDATIO52
招募中
2 期
A multicenter randomized phase II trial evaluating the efficacy and safety of intrapericardial left superior pulmonary vein ligation or division for prevention of thrombosis in the stumpmalignant tumor of the lungJPRN-UMIN000036037iigata Chest Surgery Study Group60
进行中（未招募）
不适用
A multicenter randomized phase II Trial assessing the activity of Gemcitabine - Oxaliplatin chemotherapy alone or in combination with Cetuximab in patients with advanced biliary cancer - BINGOadenocarcinoma of the biliary tract ( gallbladder, intra and/ or extrahepatic bile ducts, ampulla of Vater)EUCTR2007-001200-20-DEMedizinische Hochschule Hannover100
进行中（未招募）
1 期
A randomized, multi-center phase II trial to assess the efficay of 5-azacytidine added to standard primery therapy in elderly patients with newly diagnosed AML. - AML-AZAThe disease under investigation is newly diagnosed Acute Myeloid Leucemia (AML) in elderly patients.MedDRA version: 13.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-004583-40-DEniversitaetsklinikum Muenster234
招募中
2 期
A multicenter phase II randomized trial to evaluate systemic therapy versus systemic therapy in combination with stereotactic radiotherapy in patients with metastatic colorectal cancerBowel cancerrectum cancer1001799010017991colon cancerNL-OMON52282niversitair Medisch Centrum Utrecht105