Fase I-studie som evaluerer tolerabilitet, sikkerhet, farmakokinetikk og effektivitet av kombinert ONO-4059 og R-MPV-terapi for PCNSL
En multisenter, fase I, åpen, ukontrollert studie av ONO-4059 i kombinasjon med rituximab, metotreksat, prokarbazin og vinkristin (R-MPV) terapi for ubehandlet primært sentralnervesystem lymfom (PCNSL)
To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
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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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Tirabrutinib + R-MPV hos pasienter med nylig diagnostisert, behandlingsnaiv PCNSL
|
Specified dose, once daily
Andre navn:
Specified dose on specified days Specified dose on specified days Specified dose on specified days Specified dose on specified days |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Tolerability evaluation
Tidsramme: 29 Days
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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
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Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during induction
Tidsramme: 2 years
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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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sammendrag av plasmakonsentrasjon av tirabrutinib ved bunn- og etter 2 timers dosering
Tidsramme: 30 dager
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30 dager
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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
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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
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Complete response rate (CRR)
Tidsramme: 4 months
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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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Project Leader, Ono Pharmaceutical Co., Ltd.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Aminosyrer, peptider og proteiner
- Proteiner
- Organiske kjemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Hydrokarboner
- Hydrokarboner, syklisk
- Karboksylsyrer
- Alkaloider
- Hydrokarboner, aromatisk
- Amides
- Indoler
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Benzenderivater
- Pteriner
- Pteridiner
- Vinca -alkaloider
- Secologanin tryptaminalkaloider
- Indolalkaloider
- Indolizidiner
- Indolisiner
- Aminopterin
- Antistoffer, monoklonale, murine-avledede
- Syrer, karbosykliske
- Benzoates
- Benzamider
- Rituximab
- Metotreksat
- Vincristine
- Prokarbazin
- Tirabrutinib
Andre studie-ID-numre
- ONO-4059-13
- jRCT2071230124 (Registeridentifikator: Japan Registry of Clinical Trials)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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