An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers

Astex Pharmaceuticals, Inc.0 个研究点目标入组 300 人开始时间: 2021年12月13日最近更新: 2022年2月7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: 300

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

•1) Previous participation in an Astex-sponsored ASTX727 clinical trial (including but not limited to studies ASTX727-01, ASTX727-02, ASTX727-04, ASTX727-17, ASTX727-18, and the food effect substudy of ASTX727-06) in which the subject was treated with ASTX727 and was still on active treatment with ASTX727 at the time of study completion as determined by Astex.
•2) Subject is considered to be benefitting from ASTX727 treatment in the opinion of the treating Investigator at the time of parent study completion. (Subjects must not be withdrawn from the parent study until eligibility for this study is confirmed.)
•3) Subject is able to understand and comply with the study procedures and understands the risks involved in the study.
•4) Subject provides legally effective informed consent before undergoing any study-specific procedure.
•FE Substudy inclusion criteria:
•1) Be 18 years of age or older, at the time of signing the informed consent.
•2) Have MDS, including all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, CMML), and subjects with MDS IPSS int-1, -2, or high-risk MDS, or AML, as diagnosed according to the 2016 World Health Organization (WHO) guidelines on acute leukemia, of any subtype except M3 (acute promyelocytic leukemia), who are not candidates for intensive chemotherapy, including subjects receiving HMA treatment, who have a confirmed diagnosis and a prior confirmatory bone marrow report. Subjects who are currently receiving HMA treatment must complete the ongoing (at the time of Screening) treatment cycle before enrolling in this study; timing of start of treatment cycle with ASTX727 is at the principal investigator’s discretion.
•3) Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
•4) Have adequate organ function defined as follows:
•a. Hepatic: Total bilirubin =1.5× upper limit of normal (ULN); aspartate aminotransferase/serum glutamicoxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) =5× ULN.
•b. Renal: Calculated creatinine clearance =60 mL/min.
•5) Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential must agree to practice 1 highly effective contraceptive measure of birth control (with a failure rate of <1% per year; with low user dependency) during the substudy and for 6 months after the last dose of study treatment and must agree not to become pregnant for 6 months after completing treatment; men with female partners of childbearing potential must agree to use a condom and advise their partners to practice 1 highly effective contraceptive measure of birth control (user dependent or with low user dependency) while receiving treatment with ASTX727 and for at least 3 months after completing treatment and must agree not to father a child while receiving ASTX727 and for at least 3 months after completing ASTX727 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 72
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 72

排除标准

•1) Any subject who, in the opinion of the investigator, may have other conditions, or for whom safety data from parent study participation suggests the risks of continuing treatment with ASTX727 may outweigh the benefits.
•FE Substudy Exclusion Criteria:
•1) Known or suspected hypersensitivity to decitabine, cedazuridine, or any of the excipients in the ASTX727 tablets.
•2) Poor medical risk because of other conditions such as uncontrolled systemic diseases or active uncontrolled infections.
•3) 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 decitabine + cedazuridine, or compromise the integrity of the study outcomes.
•4) Prior gastric surgery for ulcer disease, weight loss, etc., that would impair normal motility or absorption.
•5) Second malignancy currently requiring active chemotherapy. To clarify, patients with breast or prostate cancer stable on or responding to endocrine therapy, are eligible.
•6) Known history of human immunodeficiency virus or known seropositive for hepatitis C virus or hepatitis B virus.
•7) Active uncontrolled gastric or duodenal ulcer.
•8) Subjects with acute promyelocytic leukemia.
•9) Prior cytotoxic chemotherapy for AML except for hydroxyurea to control high white blood cell (WBC) counts.
•10) Treated with any investigational drug or therapy within 2 weeks of study treatment, or 5 half-lives, whichever is longer, before the protocol-defined first dose of study treatment, or ongoing clinically significant AEs from previous treatment with investigational drug or therapy.
•11) Sensitivity to any of the study interventions or components thereof, or drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates participation in the study.
•12) 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.

研究者

发起方

Astex Pharmaceuticals, Inc.

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