NCT05043922进行中（未招募）2 期
A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of CYH33, a Selective PI3Kα Inhibitor in Patients With Recurrent/Persistent Ovary, Fallopian Tube or Primary Peritoneal Clear Cell Carcinoma
Haihe Biopharma Co., Ltd.36 个研究点 分布在 2 个国家目标入组 93 人开始时间: 2021年10月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 93
- 试验地点
- 36
- 主要终点
- Tumor ORR in patients with PIK3CA hotspot mutations.
研究概览
简要总结
The purpose of this study is to determine the treatment efficacy of CYH33 monotherapy in patients with recurrent or persistent ovarian, fallopian tube or primary peritoneal clear cell carcinoma harboring PIK3CA hotspot mutation, who received prior systemic anti-tumor treatment.
详细描述
The purpose of this study is to determine whether treatment with single agent CYH33 significantly improves ORR compared to historical efficacy data in patients with recurrent/persistent ovarian clear cell carcinoma (OCCC) harboring PIK3CA hotspot mutations who received prior systemic anti-tumor treatment.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Female patients ≥ 18 years of age
- •Provide informed consent voluntarily.
- •Patients must have histologically or cytologically confirmed recurrent or persistent ovarian, fallopian tube, or peritoneum clear cell carcinoma.
- •Patients with recurrent/persistent ovary, fallopian tube or primary peritoneal clear cell carcinoma, who have identified PIK3CA status.
- •Patients must have failed standard chemotherapy.
- •Patient must have adequate organ and bone marrow function measured within 28 days of screening.
排除标准
- •Patients are ineligible for this study if they meet any of the following criteria:
- •Patient has received any anticancer therapy
- •Patients who had prior treatment with any PI3K, mTOR or AKT inhibitor.
- •Radical radiation therapy within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
- •Any toxicities from prior treatment that have not recovered to baseline.
- •Patients who have been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug.
- •Patients who have symptomatic CNS metastasis.
- •Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product or has not recovered from major side effects.
- •Known HIV infection with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunity infection within the past 12 months; active hepatitis B and hepatitis C.
- •History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis.
- •Patients with clinically significant cardiovascular disease
研究组 & 干预措施
CYH33
Experimental
40mg daily
干预措施: CYH33 (Drug)
结局指标
主要结局
Tumor ORR in patients with PIK3CA hotspot mutations.
时间窗: through study completion, an average of 1 year
Tumor ORR per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in patients with PIK3CA hotspot mutations.
次要结局
- OS(through study completion, an average of 2 year)
- genetic and protein biomarker alterations(through study completion, an average of 1 year)
- PFS(through study completion, an average of 1 year)
研究者
研究点 (36)
Loading locations...
相似试验
已完成
2 期
A Study to Assess YH003 in Combination with Toripalimab(anti-PD-1 MAb) Injection in Patients with CancersPancreatic Ductal AdenocarcinomaMelanomaNCT05031494Eucure (Beijing) Biopharma Co., Ltd40
尚未招募
3 期
A Study of XY0206 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory AML With FLT3-ITD-Mutation (ALIVE)Acute Myeloid Leukemia With FLT3/ITD MutationNCT05876832Shijiazhuang Yiling Pharmaceutical Co. Ltd312
撤回
2 期
Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in ChildrenPainNCT02542098Purdue Pharma LP
已完成
1 期
A Phase 2 Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Multiple MyelomaMultiple Myeloma in RelapseNCT03136653Molecular Partners AG33
已完成
3 期
4EVER - Efficacy, Safety, Health Economics, Translational Research of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast CancerMetastatic Breast CancerNCT01626222Novartis Pharmaceuticals301