Fase I-studie, der evaluerer tolerabilitet, sikkerhed, farmakokinetik og effektivitet af kombineret ONO-4059- og R-MPV-terapi til PCNSL
Et multicenter, fase I, åbent, ukontrolleret studie af ONO-4059 i kombination med rituximab, methotrexat, procarbazin og vincristin (R-MPV) terapi for ubehandlet primært centralnervesystem lymfom (PCNSL)
To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Aichi-ken
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Nagoya, Aichi-ken, Japan
- Nagoya City University Hospital
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Nagoya, Aichi-ken, Japan
- Aichi Cancer Center
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Akita
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Akita, Akita, Japan
- Akita University Hospital
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Chiba
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Urayasu-shi, Chiba, Japan
- Juntendo University Urayasu Hospital
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Fukuoka
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Fukuoka, Fukuoka, Japan
- Kyushu University Hospital
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Fukuoka, Fukuoka, Japan
- Fukuoka University Hospital
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Kitakyushu-shi, Fukuoka, Japan
- Hospital of the University of Occupational and Environmental Health,Japan
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Kurume-shi, Fukuoka, Japan
- Kurume University Hospital
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Fukushima
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Fukushima, Fukushima, Japan
- Fukushima Medical University Hospital
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Gifu
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Gifu, Gifu, Japan
- Gifu University Hospital (Tokai National Higher Education and Research System)
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Gunma
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Maebashi, Gunma, Japan
- Gunma University Hospital
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Hokkaido
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Sapporo, Hokkaido, Japan
- Sapporo Medical University Hospital
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Hyōgo
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Kobe, Hyōgo, Japan
- Kobe City Medical Center General Hospital
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Nishinomiya-shi, Hyōgo, Japan
- Hyogo Medical University Hospital
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Ibaraki
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Tsukuba, Ibaraki, Japan
- University of Tsukuba Hospital
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Ishikawa-ken
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Kahoku-gun, Ishikawa-ken, Japan
- Kanazawa Medical University Hospital
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Kagawa-ken
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Kita-gun, Kagawa-ken, Japan
- Kagawa University Hospital
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Kanagawa
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Kawasaki-shi, Kanagawa, Japan
- St. Marianna University Hospital
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Yokohama, Kanagawa, Japan
- Yokohama City University Hospital
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Kochi
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Nankoku-shi, Kochi, Japan
- Kochi Medical School Hospital
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Miyazaki
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Miyazaki, Miyazaki, Japan
- University of Miyazaki Hospital
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Nagasaki
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Nagasaki, Nagasaki, Japan
- NAGASAKI University Hospital
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Nara
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Ikoma-shi, Nara, Japan
- Kindai University Nara Hospital
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Kashihara-shi, Nara, Japan
- Nara Medical University
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Niigata
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Niigata, Niigata, Japan
- Niigata University Medical & Dental Hospital
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Oita Prefecture
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Yufu-shi, Oita Prefecture, Japan
- Oita University Hospital
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Okayama-ken
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Kurashiki-shi, Okayama-ken, Japan
- Kurashiki Central Hospital
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Osaka
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Osaka, Osaka, Japan
- Osaka International Cancer Institute
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Osakasayama-shi, Osaka, Japan
- Kindai University Hospital
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Suita-shi, Osaka, Japan
- Osaka University Hospital
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Saga-ken
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Saga, Saga-ken, Japan
- Saga University Hospital
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Saitama
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Kawagoe-shi, Saitama, Japan
- Saitama Medical Center
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Shizuoka
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Sunto-gun, Shizuoka, Japan
- Shizuoka Cancer Center
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Tochigi
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Shimotsuga-gun, Tochigi, Japan
- Dokkyo Medical University Hospital
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Tokyo
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Bunkyo-ku, Tokyo, Japan
- Institute of Science Tokyo Hospital
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Koto-ku, Tokyo, Japan
- The Cancer Institute Hospital of JFCR
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Midorichō, Tokyo, Japan
- National Hospital Organization Disaster Medical Center
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Minato-ku, Tokyo, Japan
- The Jikei University Hospital
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Minato-ku, Tokyo, Japan
- Toranomon Hospital
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Shinjuku-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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Toyama
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Toyama, Toyama, Japan
- Toyama University Hospital
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Yamaguchi
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Ube-shi, Yamaguchi, Japan
- Yamaguchi University Hospital
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Yamanashi
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Chuo-shi, Yamanashi, Japan
- University of Yamanashi Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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:
- Patients with intraocular PCNSL without brain lesions
- Patients are unable to swallow oral medications
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Tirabrutinib + R-MPV hos patienter med nyligt diagnosticeret, behandlingsnaiv PCNSL
|
Specified dose, once daily
Andre navne:
Specified dose on specified days Specified dose on specified days Specified dose on specified days Specified dose on specified days |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tolerability evaluation
Tidsramme: 29 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 |
29 Days
|
|
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during induction
Tidsramme: 2 years
|
Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity. |
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sammenfatning af plasmakoncentrationen af tirabrutinib ved laveste og efter 2 timers dosering
Tidsramme: 30 dage
|
30 dage
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|
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Duration of response (DOR)
Tidsramme: 2 years
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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. |
2 years
|
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Time to response (TTR)
Tidsramme: 1 year
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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. |
1 year
|
|
Best overall response (BOR)
Tidsramme: 1 year
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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, whichever occurs first. |
1 year
|
|
Complete response rate (CRR)
Tidsramme: 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. |
4 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Project Leader, Ono Pharmaceutical Co., Ltd.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Aminosyrer, peptider og proteiner
- Proteiner
- Organiske kemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Kulbrinter
- Kulbrinter, cyklisk
- Carboxylsyrer
- Alkaloider
- Kulbrinter, aromatisk
- Amider
- Indoler
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Benzenderivater
- Pterins
- Pteridiner
- Vinca alkaloider
- Secologanin tryptamin alkaloider
- Indole alkaloider
- Indolizidiner
- Indolizines
- Aminopterin
- Antistoffer, monoklonal, murint afledt
- Syrer, carbocykliske
- Benzoates
- Benzamider
- Rituximab
- Methotrexat
- Vincristine
- Procarbazin
- Tirabrutinib
Andre undersøgelses-id-numre
- ONO-4059-13
- jRCT2071230124 (Registry Identifier: Japan Registry of Clinical Trials)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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