Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL

Registration Number
NCT06541665
Lead Sponsor
Ono Pharmaceutical Co. Ltd
Brief Summary

To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.

Detailed Description

Not available

Recruitment & Eligibility

Status
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
Read More
Exclusion Criteria
  • Patients with intraocular PCNSL without brain lesions
  • Patients are unable to swallow oral medications
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSLONO-4059-
Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSLMethotrexate-
Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSLRituximab-
Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSLProcarbazine-
Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSLVincristine-
Primary Outcome Measures
NameTimeMethod
Tolerability evaluation29 Days

The number of subjects who experienced adverse events and side effects will be tallied. In the tolerability evaluation part, the number of subjects who experienced Dose Limiting Toxicity(DLT) will be tallied

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during induction2 years

Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity.

Secondary Outcome Measures
NameTimeMethod
Duration of response (DOR)2 years

Duration of response is defined as the time between the date of first response (Complete response (CR), Complete response - unconfirmed (CRu), or partial response (PR) ) and the date of the first progressive disease(PD) according to the IPCG criteria, or date of death due to any cause, whichever occurs first.

Summary of plasma tirabrutinib concentration at trough and post 2 hours dosing30days
Time to response (TTR)1 year

Time to response is defined as the time between the date of first administration of tirabrutinib and the date of first response (CR, CRu, or PR) as determined by IRC according to the IPCG criteria.

Complete response rate (CRR)4 months

Complete response rate is defined as the proportion of patients with a best overall response of CR or CRu as determined by an independent review committee according to the IPCG criteria.

Best overall response (BOR)1 year

Best overall response based on independent review committee (IRC) response determination is defined as the best response and is derived programmatically based upon the visit responses determined by IRC from the date of administration of tirabrutinib to the date of PD as determined by IRC or the date of initiation of subsequent anticancer therapy for PCNSL, w...

Trial Locations

Locations (44)

Kindai University Hospital

🇯🇵

Osakasayama-shi, Osaka, Japan

Institute of Science Tokyo Hospital

🇯🇵

Bunkyo-ku, Tokyo, Japan

National Hospital Organization Disaster Medical Center

🇯🇵

Midori-cho, Tokyo, Japan

Aichi Cancer Center

🇯🇵

Nagoya-shi, Aichi, Japan

Nagoya City University Hospital

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Nagoya-shi, Aichi, Japan

Akita University Hospital

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Akita-shi, Akita, Japan

Juntendo University Urayasu Hospital

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Urayasu-shi, Chiba, Japan

Fukuoka University Hospital

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Fukuoka-shi, Fukuoka, Japan

Kyushu University Hospital

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Fukuoka-shi, Fukuoka, Japan

Hospital of the University of Occupational and Environmental Health,Japan

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Kitakyushu-shi, Fukuoka, Japan

Kurume University Hospital

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Kurume-shi, Fukuoka, Japan

Fukushima Medical University Hospital

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Fukushima-shi, Fukushima, Japan

Gifu University Hospital (Tokai National Higher Education and Research System)

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Gifu-shi, Gifu, Japan

Gunma University Hospital

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Maebashi-shi, Gunma, Japan

Sapporo Medical University Hospital

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Sapporo-shi, Hokkaido, Japan

Kobe City Medical Center General Hospital

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Kobe-shi, Hyogo, Japan

Hyogo Medical University Hospital

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Nishinomiya-shi, Hyogo, Japan

University of Tsukuba Hospital

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Tsukuba-shi, Ibaraki, Japan

Kanazawa Medical University Hospital

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Kahoku-gun, Ishikawa, Japan

Kagawa University Hospital

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Kita-gun, Kagawa, Japan

St. Marianna University Hospital

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Kawasaki-shi, Kanagawa, Japan

Yokohama City University Hospital

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Yokohama-shi, Kanagawa, Japan

Kochi Medical School Hospital

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Nankoku-shi, Kochi, Japan

University of Miyazaki Hospital

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Miyazaki-shi, Miyazaki, Japan

NAGASAKI University Hospital

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Nagasaki-shi, Nagasaki, Japan

Kindai University Nara Hospital

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Ikoma-shi, Nara, Japan

Nara Medical University

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Kashihara-shi, Nara, Japan

Niigata University Medical & Dental Hospital

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Niigata-shi, Niigata, Japan

Oita University Hospital

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Yufu-shi, Oita, Japan

Kurashiki Central Hospital

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Kurashiki-shi, Okayama, Japan

Osaka International Cancer Institute

🇯🇵

Osaka-shi, Osaka, Japan

Osaka University Hospital

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Suita-shi, Osaka, Japan

Saga University Hospital

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Saga-shi, Saga, Japan

Saitama Medical Center

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Kawagoe-shi, Saitama, Japan

Shizuoka Cancer Center

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Sunto-gun, Shizuoka, Japan

Dokkyo Medical University Hospital

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Shimotsuga-gun, Tochigi, Japan

The Cancer Institute Hospital of JFCR

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Koto-ku, Tokyo, Japan

The Jikei University Hospital

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Minato-ku, Tokyo, Japan

Toranomon Hospital

🇯🇵

Minato-ku, Tokyo, Japan

Tokyo Medical University Hospital

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Shinjuku-ku, Tokyo, Japan

Tokyo Women's Medical University Hospital

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Shinjuku-ku, Tokyo, Japan

Toyama University Hospital

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Toyama-shi, Toyama, Japan

Yamaguchi University Hospital

🇯🇵

Ube-shi, Yamaguchi, Japan

University of Yamanashi Hospital

🇯🇵

Chuo-shi, Yamanashi, Japan

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