EUCTR2014-002003-25-GB进行中（未招募）1 期
A Phase II Trial of Aflibercept Monotherapy With Early Dynamic Contrast Enhanced Ultrasound Monitoring in Chemorefractory Metastatic Colorectal Cancer - AusCOR
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 54
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
- •1. Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with liver metastas(es). At least one of which should not have had any focal therapy including radiofrequency ablation.
- •2. Evidence of uni-dimensionally measurable disease as defined by the Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
- •3. 18 years of age or older.
- •4. ECOG performance status of < 3.
- •5. Failed (or intolerant of) at least 2 chemotherapy regimens in advanced disease and resolution of any acute toxic effects of prior therapy e.g. radiotherapy or surgical procedure to NCI CTCv4 grade =1. No other alternative available effective treatment options.
- •6. Adequate organ function as defined by the following criteria:
- •Serum aspartate aminotransferase (AST; serum glutamic oxaloacetic transaminase [SGOT]) or serum alanine aminotransferase (ALT; serum glutamic pyruvic transaminase [SGPT]) =5 x upper limit of normal (ULN).
- •Total serum bilirubin <1.5 x ULN
- •Serum albumin =25mg/dl
- •Absolute neutrophil count =1000/µL
- •Platelets =75, 000/µL
- •Haemoglobin =9.0 g/dL
- •Serum creatinine =1.5 x ULN
- •7. Willing and able to provide fully informed consent to participate in the study
- •8. Willingness and ability to comply with scheduled visits, treatment plans,laboratory tests, and other study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Palliative radiotherapy to non-target, metastatic lesions will be allowed.
- •2. Less than 4 weeks elapsed from prior chemotherapy to the time of inclusion. Less than 4 weeks following major surgery to the time of inclusion or until the surgical wound is fully healed, whichever came later (48 hours in case of minor surgical procedure or until wound full healing observed).
- •3. Treatment with any investigational drug within 30 days prior to inclusion.
- •4. Less than 4 weeks elapsed from prior radiotherapy or prior chemotherapy to the time of inclusion.
- •5. Adverse events (with exception of alopecia, peripheral sensory neuropathy and those listed in specific exclusion criteria) from any prior anti cancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.4.0) at the time of inclusion.
- •6. History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
- •7. Other prior malignancy. Adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or any other cancer from which the patient has been disease free for > 5 years are allowed.
- •8. Any of the following within 6 months prior to inclusion: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
- •9. Any of the following within 3 months prior to inclusion: Grade 3-4 gastrointestinal bleeding/haemorrhage, treatment resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis.
- •10. Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
- •11. Any severe acute or chronic medical condition, which could impair the ability of the patient to participate to the study or to interfere with interpretation of study results
- •12. Predisposing colonic or small bowel disorders in which the symptoms were uncontrolled as indicated by baseline of > 3 loose stools daily.
- •13. Treatment with concomitant anticonvulsant agents that are CYP3A4 inducers (phenytoin, phenobarbital, carbamazepine), unless discontinued >7 days.
- •14. Pregnant or breast-feeding women. Positive pregnancy test (serum or urine ß-HCG) for women of reproductive potential.
- •15. Patients with reproductive potential (female and male) who do not agree to use an accepted effective method of contraception during the study treatment period and for at least 6 months following completion of study treatment. The definition of effective method will be left to the investigator’s judgment.
- •16. For female patients enrolled in United Kingdom, the following methods of contraception are acceptable: oral contraceptives accompanied by the use of a second method of contraception, as it is not known how oral contraceptives interact with study medications or Intra Uterine Device (IUD) or women who are surgically sterile, or women who are post –menopausal or other reasons have no chance of becoming pregnant.
- •17. Urine protein-creatinine ratio (UPCR) >1 on morning spot urinalysis or proteinuria > 500 mg/24-h.
- •18. Serum creatinine > 1.5 x upper limit of normal (ULN).
- •19. Uncontrolled hypertension (defined as blood pressure > 140/90 mmHg or systolic blood pressure >160 mmHg when diastolic blood pressure < 90 mmHg, on at least 2 repeated determinations on separate
研究者
相似试验
已完成
不适用
Investigation of clinical efficacy for Aflibercept in patients with polypoidal choroidal vasculopathy (PCV)Polypoidal Choroidal VasculopathyJPRN-UMIN000011091Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University50
进行中（未招募）
不适用
Study of Aflibercept as Maintenance Following Induction of Aflibercept in Combination with XELOX, as First-Line Treatment for Metastatic Colorectal Cancer PatientColorectal cancer metastaticMedDRA version: 16.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-000858-22-ITSanofi-Aventis Groupe
招募中
4 期
Prospective study evaluating aflibercept in patients with recurrent or prolonged diabetic macular edema after vitrectomyDiabetic macular edemaJPRN-UMIN000016036Kyushu university30
招募中
不适用
Multi-Center Study of Aflibercept Therapy for Neovascular Age-Related Macular Degeneration Using Trreat and Extend Strategyeovascular age-related macular degenerationJPRN-UMIN000016152Tokyo Women's Medical University200
已完成
不适用
Investigation of clinical efficacy of aflicbercept in patients with polypoidal choroidal vasculopathy (PCV) with resistance of ranibizumabPolypoidal choroidal vasculopathyJPRN-UMIN000012493Department of Ophthalmology, Graduate School of Medicine, The University of Tokyo30