Fas I-studie som utvärderar tolerabilitet, säkerhet, farmakokinetik och effektivitet av kombinerad ONO-4059 och R-MPV-terapi för PCNSL
En multicenter, fas I, öppen, okontrollerad studie av ONO-4059 i kombination med rituximab, metotrexat, prokarbazin och vinkristin (R-MPV) terapi för obehandlat primärt lymfom i centrala nervsystemet (PCNSL)
To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studieorter
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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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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Tirabrutinib + R-MPV hos patienter med nydiagnostiserade, behandlingsnaiva PCNSL
|
Specified dose, once daily
Andra namn:
Specified dose on specified days Specified dose on specified days Specified dose on specified days Specified dose on specified days |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Tolerability evaluation
Tidsram: 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
Tidsram: 2 years
|
Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity. |
2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sammanfattning av plasmakoncentrationen av tirabrutinib vid dalgång och efter 2 timmars dosering
Tidsram: 30 dagar
|
30 dagar
|
|
|
Duration of response (DOR)
Tidsram: 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. |
2 years
|
|
Time to response (TTR)
Tidsram: 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. |
1 year
|
|
Best overall response (BOR)
Tidsram: 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, whichever occurs first. |
1 year
|
|
Complete response rate (CRR)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Project Leader, Ono Pharmaceutical Co., Ltd.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Aminosyror, peptider och proteiner
- Proteiner
- Organiska kemikalier
- Heterocykliska föreningar
- Heterocykliska föreningar, 2-ring
- Heterocykliska föreningar, smältring
- Kolväten
- Kolväten, cykliska
- Karboxylsyror
- Alkaloider
- Kolväten, aromatisk
- Amider
- Förenad
- Antikroppar, monoklonal
- Antikroppar
- Immunglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Bensiverivat
- Pteriner
- Pteridiner
- Vinca alkaloider
- Secologanin tryptaminalkaloider
- Indolalkaloider
- Indolizidiner
- Indoliziner
- Aminopterin
- Antikroppar, monoklonal, murin härledd
- Syror, karbocyklisk
- Bensoat
- Bensamider
- Rituximab
- Metotrexat
- Vincristine
- Prokarbazin
- tirabrutinib
Andra studie-ID-nummer
- ONO-4059-13
- jRCT2071230124 (Registeridentifierare: Japan Registry of Clinical Trials)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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