EUCTR2016-004907-30-FR进行中（未招募）1 期
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination with Azacitidine in Subjects = 18 Years of Age with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 392
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
- •Subjects must meet all of the following criteria to be eligible for inclusion in the study:
- •1. Be = 18 years of age.
- •2. Have previously untreated AML, defined according to World Health Organization (WHO) criteria, with = 20% leukemic blasts in the bone marrow. Subjects with extramedullary disease alone (ie, no detectable bone marrow and no detectable peripheral blood AML) are not eligible for the study.
- •3. Have an isocitrate dehydrogenase 1 (IDH1) mutation as determined by central laboratory testing (using an investigational polymerase chain reaction [PCR] assay, Abbott RealTime IDH1) in their bone marrow aspirate and/or peripheral blood sample.
- •4. Have an ECOG PS score of 0 to 2.
- •5. Have adequate hepatic function, as evidenced by:
- •a. Serum total bilirubin = 1.5 times the upper limit of normal (× ULN), unless considered to be due to Gilbert’s disease or underlying leukemia, where it must be < 3 × ULN
- •b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) = 3.0 × ULN, unless considered to be due to underlying leukemia
- •6. Have adequate renal function, as evidenced by serum creatinine = 2.0 × ULN or creatinine clearance > 40 mL/min based on the Cockcroft-Gault glomerular filtration rate.
- •7. Have agreed to undergo serial blood and bone marrow sampling.
- •8. Be able to understand and willing to sign an informed consent form (ICF).
- •9. Be willing to complete QoL assessments during study treatment and at the designated time points following treatment discontinuation.
- •10. If female with reproductive potential, must have a negative serum pregnancy test prior to the start of study therapy. Female subjects with reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion or who have not been naturally postmenopausal for at least 24 consecutive months. Females of reproductive potential, as well as fertile men and their female partners of reproductive potential, must agree to use 2 effective forms of contraception (including at least 1 barrier form) from the time of giving informed consent throughout the study and for 90 days (both females and males) following the last dose of study drug(s). Effective forms of contraception are defined as hormonal oral contraceptives, injectables, patches, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal ligation, condoms with spermicide, or male partner sterilization.
- •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 168
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 224
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study:
- •1. Are candidates for and willing to receive intensive induction chemotherapy (IC) for their AML.
- •2. Have received any prior treatment for AML with the exception of hydroxyurea.
- •3. Have received a hypomethylating agent for myelodysplastic syndrome (MDS).
- •4. Subjects who had previously received an experimental agent for MDS may not be randomized until a washout period of at least 5 half-lives of the experimental agent has elapsed since the last dose of that agent.
- •5. Have received prior treatment with an IDH1 inhibitor.
- •6. Have a known hypersensitivity to any of the components of AG-120, matched placebo, or azacitidine.
- •7. Are female and pregnant or breastfeeding.
- •8. Are taking known strong cytochrome P450 (CYP) 3A4 inducers or sensitive CYP3A4 substrate medications with a narrow therapeutic window, unless they can be transferred to other medications within = 5 half-lives prior to dosing.
- •9. Are taking P-glycoprotein (P-gp) transporter-sensitive substrate medications with a narro therapeutic window, unless they can be transferred to other medications within = 5 half-lives prior to administration of study treatment.
- •10. Have an active, uncontrolled, systemic fungal, bacterial, or viral infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
- •11. Have a prior history of malignancy other than MDS or myeloproliferative disorder, unless the subject has been free of the disease for = 1 year prior to the start of study treatment. However, subjects with the following history/concurrent conditions or similar indolent cancer are allowed to participate in the study:
- •a. Basal or squamous cell carcinoma of the skin
- •b. Carcinoma in situ of the cervix
- •c. Carcinoma in situ of the breast
- •d. Incidental histologic finding of prostate cancer
- •12. Have had significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association Class III or IV congestive heart failure, myocardial infarction, unstable angina, and/or stroke.
- •13. Have a heart-rate corrected QT interval using Fridericia’s method (QTcF) = 470 msec or any other factor that increases the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome). Subjects with prolonged QTcF interval in the setting of bundle branch block may participate in the study.
- •14. Have an active viral infection caused by human immunodeficiency virus, hepatitis B virus, or hepatitis C virus that cannot be controlled by treatment.
- •15. Have dysphagia, short-gut syndrome, gastroparesis, or any other condition that limits the ingestion or gastrointestinal absorption of orally administered drugs.
- •16. Have uncontrolled hypertension (systolic blood pressure [BP] > 180 mmHg or diastolic BP > 100 mmHg).
- •17. Have clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid during Screening is only required if there is a clinical suspicion of CNS involvement by leukemia during Screening.
- •18. Have immediate, life-threatening, severe complications of leukemia, such as uncontrolled bleeding, pneumonia with hypoxia or sepsis, and/or disseminated intravascular coagulation.
- •19. Have any other medical or psychological condition deemed by th
研究者
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