Phase I study evaluating tolerability, safety, pharmacokinetics, and efficacy of combined ONO-4059 and R-MPV therapy for PCNSL
Active, not recruiting
- Conditions
- Primary central nervous system lymphoma
- Registration Number
- jRCT2071230124
- Lead Sponsor
- Ono Pharmaceutical Co.,LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Patients diagnosed with PCNSL
- Patients who have not received treatment for PCNSL in the past
- Patients with ECOG Performance Status 0-2
- Patients expected to survive for 6 months or more
Exclusion Criteria
1.Patients with intraocular PCNSL without brain lesions 2.Patients are unable to swallow oral medications
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method tolerability To confirm the tolerability of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients
safety To confirm the safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of ONO-4059 To evaluate the pharmacokinetics of ONO-4059 when ONO-4059 is administered in combination with R-MPV therapy in untreated PCNSL patients.
Efficacy of ONO-4059 To investigate the efficacy of ONO-4059 in combination with R-MPV therapy in untreated PCNSL patients.