NCT04705090Unknown2 期
A Single-arm, Open, Multicenter, Phase II Study to Investigate the Efficacy and Safety of YY-20394 in Patients With Relapsed or Refractory Peripheral T/NK Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 主要终点
- ORR
研究概览
简要总结
A single-arm, open, multicenter study to investigate the efficacy and safety of YY-20394, an oral small molecular inhibitor of PI3K-delta, in patients with relapsed or refractory peripheral T/NK cell lymphoma.
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
- •Males and/or females over age
- •Histologically or cytologically confirmed diagnosis of relapsed or refractory peripheral T/NK cell lymphoma.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •Life expectancy of at least 3 months.
- •At least one measurable lesion according to Lugano
- •Adequate organ function.
- •Had anti-tumor treatment within 2 weeks prior to the first dose of investigational product (including TKI, Chinese herbal anti-tumor treatment); within 4 weeks prior to the first dose of investigational product (including chemotherapy, radiotherapy, immunotherapy and major surgery); other targeted therapies with 5 half-life period prior to the first dose.
- •Men and women of childbearing potential are willing to employ an effective method of contraception for the entire duration of study and 6 months after the last dose.
- •Volunteers did not participate in other clinical trials within 1 month prior to study entry.
- •Provision of signed and dated, written informed consent prior to any study- specific evaluation.
排除标准
- •Previous treatment with any PI3K-delta inhibitors.
- •Uncontrolled pleural effusion and ascites.
- •The dosage of steroid hormone (prednisone equivalent) was greater than 20mg/day, and lasted for more than 14 days.
- •Medical conditions in swallowing difficulty, malabsorption, or other chronic gastrointestinal disease that may hamper compliance and/ or absorption of the investigational agent.
- •Drugs that may prolong the QT (such as anti-arrhythmic drugs) could not be interrupted during the study period.
- •Evidence of central nervous system involvement of the malignancy, including invasion of brain parenchyma and meninges, or spinal cord compression.
- •Have active viral, bacterial, fungal, or other infections that require systematic treatment (e.g., active tuberculosis), excluding nail bed fungal infections.
- •Active infection with hepatitis B and C virus (volunteers with HBsAg or HBcAb positive but HBV-DNA negative, or HCV antibody positive but HCV-RNA negative can be enrolled).
- •History of immune deficiency (acquired and congenital), or history of organ transplantation, or allogeneic bone marrow or hematopoietic stem cell transplantation; with active autoimmune disease or history of autoimmune disease (e.g., autoimmune enteritis and systemic lupus erythematosus).
- •prior autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study drug.
- •Presence of severe or uncontrolled cardiovascular disease.
- •Medical history of active bleeding within 2 months prior to study entry, or currently achieved anticoagulant therapy, or susceptible to bleed by the judgement of investigator.
- •Presence of concomitant diseases that are seriously endanger the safety of patient or affect the completion of the study by the investigator's judgment (e.g., uncontrolled hypertension, diabetes, thyroid diseases).
- •Had received GCSF or blood transfusion treatment within 14 days prior to study entry.
- •Female subjects of childbearing potential have a positive pregnancy test at the baseline.
- •Medical history of other primary malignant tumors in the past 5 years except for the following: clinically cured cervical or breast carcinoma in situ, local basal cell or squamous cell carcinoma of the skin, thyroid tumor.
- •Adverse events occurred during previous anticancer therapy have not been recovered to ≤1 (CTCAE 5.0) except toxicity with no significant risk determined by investigator such as alopecia.
- •Live vaccine was administered within 30 days prior to the first dose of the investigational drug, or was scheduled to be administered during the study period.
- •Judgment by the investigator that the volunteer should not participate in the study.
研究组 & 干预措施
YY-20394 treatment
Experimental
YY-20394 tablets, 20mg spec, 80mg QD, 28 days for each cycle.
干预措施: YY-20394 treatment (Drug)
结局指标
主要结局
ORR
时间窗: up to 12 months
Objective Response Rate
次要结局
- DOR(up to 12 months)
- PFS(up to 12 months)
- DCR(up to 12 months)
- TTR(up to 12 months)
- Safety and Tolerability(up to 12 months)
研究者
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