jRCT2021220030已完成不适用
A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TTI-622 (PF-07901801), A SINGLE AGENT IN JAPANESE PARTICIPANTS WITH RELAPSED OR REFRACTORY HEMATOLOGIC MALIGNANCIES
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 主要终点
- Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit(—)
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Relapsed or refractory lymphoma (Hodgkin's or non-Hodgkin's) or multiple myeloma
- •Disease must have progressed with standard anticancer therapies
- •measurable disease
- •Capable of giving signed informed consent
- •Eastern cooperative oncology group performance status 0 or 1
- •Adequate organ functions
排除标准
- •Exclusion Criteria:
- •Known, current central nervous system or interstitial lung disease involvement
- •History of hemolytic anemia or positive direct antiglobulin test or active bleeding disorder
- •Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent
- •Significant cardiovascular disease
- •Other significant medical condition unrelated to the primary malignancy
- •Radiation therapy within 14 days of study treatment administration
- •Hematopoietic stem cell transplant within 90 days before the planned start of study treatment
- •Antiplatelet/anticoagulant agents within 14 days before planned start of study treatment
- •Patients sustaining major surgery at least 4 weeks prior to study enrollment
- •Use of any investigational agent or any anticancer drug within 14 days before planned start of study treatment
- •Prior anti-CD47 and anti-Signal Regulatory Protein alpha therapy
- •Active, uncontrolled bacterial, fungal, or viral infection
- •Investigator site staff directly involved in the conduct of the study and their family members
结局指标
主要结局
Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma
时间窗: up to 21 days
Number of participants with DLTs
次要结局
未报告次要终点
研究者
相似试验
尚未招募
不适用
A Study to Learn About a Study. Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe DiseasejRCT2031240698Pfizer Japan Inc.2,330
招募中
不适用
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent MigraineMigrainejRCT2051240163Pfizer Japan Inc.200
尚未招募
不适用
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual MigraineMenstrual MigrainejRCT2031250041Pfizer Japan Inc.723
招募中
不适用
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe AsthmaAsthmajRCT2031250163Pfizer Japan Inc.252
招募中
不适用
A Study to Learn About the Study Medicine Called PF-07868489 in People With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionjRCT2051240229Pfizer Japan Inc.90
