A phase 1 study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ONO-7018 in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) in Japan
- Conditions
- Non-Hodgkin Lymphoma
- Registration Number
- jRCT2021240028
- Lead Sponsor
- Ono Pharmaceutical Co.,LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 24
1.Patient with histologically/cytologically confirmed diagnosis of any of the subtypes of B-cell NHL or T-cell NHL defined below as documented by medical records and with histology based on criteria established by the World Health Organization (Swerdlow 2017) 2.Relapsed or refractory patient who is refractory or intolerant to standard therapy or for whom, in the opinion of the investigator, there is no appropriate treatment for the primary disease. 3.Patient who has measurable disease 4.ECOG PS 0 to 2 5.Life expectancy of at least 3 months
1.Any serious or uncontrolled medical disorder that may increase the risk associated with study participation or study treatment, or interfere with the interpretation of study results 2.Patient with malignancies other than lymphoid malignancy allowed per inclusion criteria 3.Prior treatment with a MALT1 inhibitor 4.Patient is unable to swallow tablets
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method - To assess the tolerability and safety of ONO-7018 in patients with relapsed or refractory NHL
- Secondary Outcome Measures
Name Time Method Efficacy of ONO-7018 To assess the efficacy of ONO-7018 in patients with relapsed or refractory NHL
PK profile of ONO-7018 To assess the PK profile of ONO-7018