A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects with Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)

Astex Pharmaceuticals, Inc.0 个研究点目标入组 168 人开始时间: 2021年6月14日最近更新: 2021年7月12日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Astex Pharmaceuticals, Inc.
入组人数: 168

研究概览入排标准研究者记录与标识符相似试验

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

•Inclusion Criteria
•Subjects must fulfill all of the following inclusion criteria.
•1) Able to understand and comply with the study procedures, understand the risks involved in the study, and
•provide written informed consent before the first study-specific procedure.
•2) Men or women =18 years with IPSS low risk or Int-1 MDS (all subjects). Subjects must have had at least 1 of
•the following disease-related criteria during the 8 weeks before randomization:
•a) Red blood cell (RBC) transfusion dependence of 2 or more units of RBCs or Hb of <8.5 g/dL in at least 2 blood counts prior to randomization.
•b) ANC of <0.5 × 109/L in at least 2 blood counts prior to randomization.
•c) Platelet counts of <50 × 109/L in at least 2 blood counts prior to randomization.
•3) ECOG performance status of 0 to 2.
•4) Adequate organ function defined as follows:
•a) Hepatic: Total or direct bilirubin =2 × upper limit of normal (ULN); aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) =5 × ULN.
•b) Renal: serum creatinine =1.5 × ULN or calculated creatinine clearance or glomerular filtration rate =50 mL/min.
•5) Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group)
•must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential must agree to practice 2 highly effective contraceptive measures of birth control (as described in the protocol) and must agree not to become pregnant for 6 months after completing treatment; men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures of birth control (as described in the protocol) and must agree not to father a child while receiving treatment with ASTX727 and for at least 3 months after completing treatment.
•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 16
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 144

排除标准

•Subjects meeting any of the following exclusion criteria will be excluded from the study:
•1. Treatment with any investigational drug or therapy within 2 weeks before study treatment, or 5 half-lives,
•whichever is longer, before the first dose of study treatment, or ongoing clinically significant AEs from previous treatment.
•2. Prior treatment with azacitidine, decitabine or gaudecitabine.
•3. Treatments for MDS, including erythropoietins, colony-stimulating factors (CSFs), thrombopoietins, chemotherapy, and immunosuppression including calcineurin inhibitors, glucocorticoids, etc., must be concluded 1 month prior to study treatment.
•4. Diagnosis of chronic myelomonocytic leukemia (CMML).
•5. Poor medical risk because of other conditions such as uncontrolled systemic diseases or active uncontrolled infections.
•6. Known significant mental illness or other condition, such as active alcohol or other substance abuse or addiction, that in the opinion of the investigator predisposes the subject to high risk of noncompliance with the protocol.
•7. Life-threatening illness, medical condition or organ system dysfunction, or other reasons including laboratory abnormalities, which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ASTX727 LD, or compromise the integrity of the study outcomes.
•8. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, prostate cancer or breast cancer under control with hormone therapy, or other cancer from which the subject has been disease free for at least 1 year.
•9. Known active infection with human immunodeficiency virus or hepatitis viruses.

研究者

发起方

Astex Pharmaceuticals, Inc.

相似试验

进行中（未招募）

1 期

A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects with Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)ower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)MedDRA version: 20.0Level: HLTClassification code 10028536Term: Myelodysplastic syndromesSystem Organ Class: 100000004851MedDRA version: 27.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2019-003281-40-BETaiho Oncology, Inc.128

进行中（未招募）

1 期

EUCTR2019-003281-40-DETaiho Oncology, Inc.168

进行中（未招募）

1 期

A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects with Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)

EUCTR2019-003281-40-ITASTEX PHARMACEUTICALS128

进行中（未招募）

2 期

A comparison of response to treatment in patients with Myelodysplastic Syndrome/Myeloproliferative Neoplasm (MDS/MPN) Overlap Syndromes taking ASTX727 versus best supportive careMyelodysplastic Syndrome/Myeloproliferative Neoplasm (MDS/MPN) Overlap SyndromesCancer

ISRCTN30808508niversity of Birmingham77

已完成

1 期

Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDSMyelodysplastic Syndromes

NCT03502668Taiho Oncology, Inc.160