JPRN-jRCT2031220276招募中1 期
A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation - LOXO-PIK-21001 (J4C-OX-JZUA)
Masaki Takeshi0 个研究点目标入组 260 人开始时间: 2022年8月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Have advanced breast cancer or another solid tumor with the presence of a phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) H1047R mutation (or other Sponsor and safety review committee (SRC) -approved, activating PIK3CA mutations other than H1047R mutation)
- •-Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.
- •-Have stopped all cancer treatment and have recovered from the major side effects
- •-Have adequate organ function, as measured by blood tests
- •-Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- •-Patients must have
- •-Measurable disease
- •---Patients with non-breast tumor types must have at least 1 measurable lesion
- •-Non-measurable bone disease (at least 1 bone lesion in breast cancer patients only)
- •-For patients with an estrogen receptor (ER) + breast cancer diagnosis:
- •-If female, must be postmenopausal
- •-If male, must agree to use hormone suppression
- •-Phase 1a:
- •--Dose escalation and backfill patients:
- •-Advanced solid tumor
- •-Patients may have had up to 5 prior regimens for advanced disease
- •-Phase 1b:
- •-ER+/human epidermal growth factor receptor 2 (HER2) - advanced breast cancer
- •-Patients may have had up to 5 prior regimens for advanced disease
- •----Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required
- •-ER+/HER2- advanced breast cancer
- •-Patients may have had up to 2 prior regimens for advanced disease.
- •-ER+/HER2- advanced breast cancer
- •-Patients may have had up to 5 prior regimens for advanced disease.
- •----Prior CDK4/6 inhibitor therapy required.
- •-Have a diagnosis of diabetes mellitus Type 2
- •-Advanced breast cancer
- •-Patients may have had up to 5 prior regimens for advanced disease.
- •-Advanced solid tumor
- •-Patients may have had up to 3 prior regimens for advanced disease
- •-ER+/HER2- advanced breast cancer
- •-Patients may have had up to 5 prior regimens for advanced disease
- •-Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required
排除标准
- •-Medical Conditions
- •-Colorectal cancer
- •-Endometrial cancers with specific concurrent oncogenic alterations
- •-A history of known active or suspected
- •-Diabetes mellitus Type 1 or
- •-Diabetes mellitus Type 2 requiring antidiabetic medication (Phase 1a and all parts of Phase 1b except Part C).
- •-Serious concomitant systemic disorder
- •-Known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
- •-Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process
- •-Prior exposure to phosphatidylinositol 3-kinase/protein kinase B/mammalian target of rapamycin (PI3K/AKT/mTOR) inhibitor(s), except in certain circumstances
研究者
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