EUCTR2018-000482-36-ES进行中（未招募）1 期
A pilot study to assess the safety, tolerability, dose finding and efficacy of ORY-1001 in combination with azacitidine in older patients with AML in first line therapy. - ALICE
Oryzon Genomics S. A.0 个研究点目标入组 30 人开始时间: 2018年6月15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
- 30
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. Subjects = 60 years of age with AML according to World Health Organization (WHO) classification, who are considered by the investigator ineligible for intensive chemotherapy regimen at that time or have refused standard chemotherapy.
- •2. Blasts at least 20% of bone marrow and/or = 20 % in peripheral blood.
- •3. Subjects may not have received prior treatment for AML other than Hydroxyurea.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- •5. Platelets = 100 x10e9/ L without transfusion (in the opinion of the investigator).
- •6. Chemical laboratory parameters within the following range:
- •a. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3x the upper limit of normal (ULN).
- •b. Total bilirubin = 1.5 x the ULN; patients with Gilbert’s syndrome can enroll if conjugated bilirubin is within normal limits.
- •7. Patients with preserved renal function: serum creatinine = 1.5 mg /dl.
- •8. Patients must be capable of understanding and complying with protocol requirements, and they must be able and willing to sign a written informed consent, and willing to complete all scheduled visits and assessments at the institution administering.
- •9. Life expectancy of at least 3 months in the opinion of the investigator.
- •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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •1. Malignancies other than AML within 1 year prior to start treatment, except for those that are in complete remission, no treatment is required and with a minimal risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ treated surgically with curative intent.
- •2. Patients with uncontrolled hypertension (in the opinion of the investigator).
- •3. Patients with uncontrolled diabetes (in the opinion of the investigator).
- •4. Active hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
- •5. Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
- •6. Inter-current illness or social situation that will limit compliance with study requirements. Any serious underlying medical or psychiatric condition (e.g. alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the patient to understand informed consent or that in the opinion of the investigator would contraindicate the patient’s participation in the study or confound the results of the study.
- •7. A physical exam or laboratory finding that contraindicates the use of investigational therapy or otherwise places the patient at excessively high risk for treatment, as determined by the Investigator.
- •8. Patients medicated with anti-depressants reported to have KDM1A/LSD1 inhibitory activity: tranylcypromine or phenelzine.
- •9. History of central nervous system (CNS) disease involvement or prior history of NCI CTCAE Grade = 3 drug-related CNS toxicity.
- •10. Evidence of active uncontrolled viral, bacterial, or systemic fungal infection. Prophylactic therapy according to institutional protocols is acceptable.
- •11. Peripheral white blood cell (WBC) count = 20 x 10e9/L on Day 1 prior to treatment. Hydroxyurea or 6-mercaptopurine are allowed until 24 hours prior study treatment start.
- •12. Pregnant or lactating / breastfeeding women.
- •13. Fertile women of childbearing potential (WCBP) not willing to use double barrier methods of contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) during the trial and 90 days after the end of treatment. Male patients whose partners are not willing to use double-barrier methods of contraception.
研究者
相似试验
进行中（未招募）
1 期
Study to assess the safety, tolerability, dose finding and efficacy ORY-1001 in combination with platinum-etoposide chemotherapy in patients with relapsed, extensive-stage disease small cell lung cancerEUCTR2018-000469-35-ESOryzon Genomics S. A.33
已完成
不适用
A preliminary study to examine and evaluate the effect of obeticholic acid (INT-747) for the treatment of portal hypertension in patients with alcoholic liver diseaseCirrhosisISRCTN22662520Intercept Pharmaceuticals Inc34
招募中
1 期
Study to evaluate safety and tolerability of a Traditional Chinese Herbal medicine combination AL” (Astragalus membranaceus and Ligustrum lucidum) in people with advanced cancer.Cancer - Any cancerCancerACTRN12615001203549Concord Repatriation General Hospital25
进行中（未招募）
不适用
Pilot Study Of Obeticholic Acid In Portal HypertensioPortal Hypertension in Patients with CirrhosisMedDRA version: 14.1Level: PTClassification code 10036200Term: Portal hypertensionSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2010-023241-29-ATIntercept Pharmaceuticals Inc78
进行中（未招募）
不适用
An Early Stage Study to Evaluate the Safety, Tolerability and Efficacy of the Medicinal Product Obeticholic Acid for the Treatment of Portal Hypertension, a liver disease.EUCTR2010-023241-29-GBIntercept Pharmaceuticals Inc78