NCT04108325Unknown1 期
A Single-Arm, Open-Label, Multi-Center, Phase Ib Study of YY-20394 in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 58
- 试验地点
- 1
- 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 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 18
- •Histologically or cytologically confirmed diagnosis of relapsed or refractory peripheral T 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 IRWG.
- •Adequate organ function.
- •Had anti-tumor treatments greater than or equal to 2 weeks prior to the first dose of investigational product (including TKI, chemotherapy, radiotherapy, immunotherapy and major surgery).
- •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.
- •Able to comply with the protocol judged by investigator.
- •Provision of signed and dated, written informed consent prior to any study- specific evaluation.
排除标准
- •Previous treatment with any PI3K-delta ihinibitors.
- •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, malabsorption, or other chronic gastrointestinal disease that may hamper compliance and/or absorption of the investigational agent.
- •During the study period, drugs that may prolong the QT (such as anti arrhythmic drugs) could not be interrupted.
- •Evidence of central nervous system involvement of the malignancy, including invasion of brain parenchyma and meninges, or spinal cord compression.
- •Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy(such as pneumonia).
- •Active infection with hepatitis B and C virus ( Volunteers with HBsAg or HBcAb positive and HBV-DNA greater than or equal to 1000 coRpies/ml or 200IU/ml; HCV antibody and HCV-RNA positive ).
- •History of immune deficiency ( acquired or congenital ), or history of organ transplantation, or allogeneic bone marrow or hematopoietic stem cell transplantation.
- •Presence of severe or uncontrolled cardiovascular disease.
- •The baseline pregnancy test was positive in pregnant women, lactating women or fertile women.
- •According to the judgement of the investigator, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study (such as severe hypertension, diabetes, thyroid diseases, etc.).
- •Medical history of other primary malignant tumors in the past 5 years except for the following: clinically cured cervical in situ, local basal cell carcinoma of the skin.
研究组 & 干预措施
YY-20394
Experimental
YY-20394 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.
干预措施: YY-20394 (Drug)
结局指标
主要结局
ORR
时间窗: up to 12 months
Objective Response Rate
DCR
时间窗: up to 12 months
Disease control rate
Safety and Tolerability
时间窗: up to 12 months
safety and tolerability of investigational product assessed as the number of participants experiencing adverse events (AEs, CTCAE5.0) or abnormalities in vital signs, laboratory tests, or electrocardiograms.
次要结局
未报告次要终点
研究者
研究点 (1)
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