2023-503272-25-00已完成2 期
Phase 2, open-label, single-arm rollover study to evaluate long-term Safety in subjects who participated in other Celgene sponsored CC-486 (oral Azacitidine) clinical trials in Hematological disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Safety: type, frequency, severity, and relationship of treatment emergent adverse events (AEs) to investigational product (CC-486).
研究概览
简要总结
To evaluate the long-term safety of CC-486 in participants who have received CC-486 as monotherapy in the parent CC-486 studies and whom the Investigators feel may derive clinical benefit from continuing treatment with CC 486.
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
- •Previously participated in, received CC-486, and continues to fulfill the eligibility criteria in one of the parent CC-486 studies
- •Continue to derive clinical benefit from treatment with CC-486 as per Investigator’s opinion.
- •In order to be enrolled for the survival follow up in the Follow up Phase, participants must have been in a parent CC-486 study where monitoring for survival was required.
- •Both women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must use an efficient method of contraception after the last dose of CC-486 in the parent CC-486 study and prior to the 1st dose of CC-486 in this study without interruption; throughout participation in this study, and for a period after treatment completion as specified in the protocol.
排除标准
- •Concomitant use of drugs that are prohibited.
- •Prior chemotherapy (including injectable azacitidine), radiotherapy or any investigational agent after the last dose of CC-486 received in the parent CC 486 study.
- •Received CC-486 in combination with another compound during the parent CC-486 study.
- •Transition into rollover study ≥ 45 days after End of Study visit of the parent CC-486 study.
- •Pregnant or lactating females. There are no exclusion criteria to prevent entry or remaining on the follow-up phase of this study
结局指标
主要结局
Safety: type, frequency, severity, and relationship of treatment emergent adverse events (AEs) to investigational product (CC-486).
Safety: type, frequency, severity, and relationship of treatment emergent adverse events (AEs) to investigational product (CC-486).
次要结局
- Survival: time from randomization until death from any cause.
研究者
GSM-CT
Scientific
Celgene Corp.
研究点 (1)
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