2024-516293-29-01招募中2 期
An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 79
- 试验地点
- 15
- 主要终点
- Safety as measured by AEs
研究概览
简要总结
To provide ongoing long-term treatment with ASTX727 for subjects who were benefiting from ASTX727 treatment in a previous Astex/Taiho sponsored clinical study. To obtain long-term safety information.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Safety follow-up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Previous participation in an Astex/Taiho-sponsored ASTX727 clinical trial (including but not limited to studies ASTX727-01, ASTX727-02, ASTX727-04, ASTX727-17 and 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 the Sponsor.
- •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 (Subjects must not be withdrawn from the parent study until eligibility for this study is confirmed.)
- •Subject is able to understand and comply with the study procedures and understands the risks involved in the study.
- •Subject provides legally effective informed consent before undergoing any study-specific procedure.
- •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, agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period, 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.
排除标准
- •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.
结局指标
主要结局
Safety as measured by AEs
Safety as measured by AEs
次要结局
未报告次要终点
研究者
Hamdy Elsayed
Scientific
Taiho Oncology Inc.
研究点 (15)
Loading locations...
相似试验
已完成
4 期
This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis2023-504869-23-00AbbVie Deutschland GmbH & Co. KG272
招募中
1 期
A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor PatientsNCT07260305Kangabio AUSTRALIA LTD PTY57
招募中
2 期
A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and PharmacokineticsNCT07260500Changchun GeneScience Pharmaceutical Co., Ltd.72
招募中
3 期
A study to evaluate the efficacy and safety of Clascoterone solution in treatment of male pattern hair loss.Androgenetic Alopecia2023-504421-39-00Cassiopea S.p.A.629
招募中
1 期
A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D MutationNCT07259590Genfleet Therapeutics (Shanghai) Inc.126