IPI-926 Extension Protocol for Continuation of IPI-926 Treatment in Patients Experiencing Clinical Benefit While Enrolled in an IPI-926 Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Incidence of adverse events (AEs) and serious adverse events (SAEs), and laboratory test results
研究概览
简要总结
A treatment protocol that enables patients to have continued access to IPI-926.
详细描述
The extension protocol is a continuation of treatment with IPI-926, as administered to each individual patient during participation in their original IPI-926 protocol.
Patients who are completing their participation in the original IPI-926 protocol in which they enrolled, as defined in the original protocol, and, have stable disease or confirmed complete or partial response as defined by the original protocol may continue to receive treatment with IPI-926 in the extension protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form
- •Currently receiving IPI-926 while participating in an Infinity-sponsored IPI-926 study. Note: For blinded studies, patient's treatment assignment must be unblinded according to the instructions in the original protocol to confirm they are receiving IPI-
- •Eastern Cooperative Oncology Group (ECOG) performance status: 0 or
- •Documented response or stable disease, as defined in the original protocol, at the time of entry to the extension study.
- •Willingness and ability to continue IPI-926 dispensation and follow-up procedures at the current investigational site.
- •Willingness and ability to comply with scheduled visits, treatment plans, and laboratory tests and other study procedures.
- •Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum or urine pregnancy test prior to treatment. All WCBP, all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study.
排除标准
- •Discontinued IPI-926 or withdrew informed consent to participate in original Infinity-sponsored IPI-926 study.
- •Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study.
研究组 & 干预措施
IPI-926
干预措施: IPI-926 (Drug)
结局指标
主要结局
Incidence of adverse events (AEs) and serious adverse events (SAEs), and laboratory test results
时间窗: Up to 30 days after the last patient study visit
Monitoring of AEs, including SAEs as well as review of laboratory sample test data to assess safety and tolerability of IPI-926
次要结局
未报告次要终点