A Phase I Study of Oral BGJ398 in Asian Patients
6. desember 2020 oppdatert av: Novartis Pharmaceuticals
A Phase I Study of Oral BGJ398 in Asian Patients With Advanced Solid Tumor Having Alterations of the FGF-R Pathway
This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
This is a multi-center, open label, dose finding, phase I study of oral single agent BGJ398, administered on a continuous once and/or twice daily schedule.
Studietype
Intervensjonell
Registrering (Faktiske)
9
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Aichi
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Nagoya-city, Aichi, Japan, 466-8560
- Nagoya University Hospital
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- National Cancer Center Hospital East (NCEE)
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Hyogo
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Kobe-shi, Hyogo, Japan, 650-0017
- Novartis Investigative Site
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Osaka
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Sayama, Osaka, Japan, 589 8511
- Novartis Investigative Site
-
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Shizuoka
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Sunto-gun, Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
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-
-
-
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Guangzhou, Kina, 510060
- Novartis Investigative Site
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Guangdong
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Guangzhou, Guangdong, Kina, 51000
- Novartis Investigative Site
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- Novartis Investigative Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients with advanced solid tumors with FGF-R alteration
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate organ function
Exclusion Criteria:
- Patients with untreated and/or symptomatic metastatic Central Nerve System (CNS) disease
- Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: BGJ398
Eligible participants received oral BGJ398 once daily or twice daily.
Patients may continue treatment with BGJ398 until the patient experiences unacceptable toxicity or progressive disease.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence rate and category of dose limiting toxicities (DLTs)
Tidsramme: First cycle of 28 days
|
Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398
|
First cycle of 28 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs)
Tidsramme: From within 21 days of first treatment to 28 days after treatment discontinuation
|
To characterize the safety and tolerability of oral BGJ398
|
From within 21 days of first treatment to 28 days after treatment discontinuation
|
|
Changes in hematology and chemistry values
Tidsramme: From baseline to 28 days after treatment discontinuation
|
hematology and chemistry values
|
From baseline to 28 days after treatment discontinuation
|
|
Assessments of physical examinations, vital signs and electrocardiograms (ECGs)
Tidsramme: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
|
Participants will be followed for the duration of treatment, an expected average of 24 weeks.
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|
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Time vs. concentration profiles
Tidsramme: 1 to 10 time points (0, 0.25, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose) up to 24 weeks
|
To determine the pharmacokinetic (PK) profiles (Cmax, AUC, Tmax, T1/2, etc) of oral BGJ398 including known pharmacologically active metabolites
|
1 to 10 time points (0, 0.25, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose) up to 24 weeks
|
|
Preliminary anti-tumor activity
Tidsramme: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
|
Assessed based on RECIST version 1.1
|
Participants will be followed for the duration of treatment, an expected average of 24 weeks.
|
|
Best overall response (BOR)
Tidsramme: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
|
Assessed by investigator per RECIST version 1.1.
BOR is the best response recorded until disease progression.
|
Participants will be followed for the duration of treatment, an expected average of 24 weeks.
|
|
Overall response rate (ORR)
Tidsramme: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
|
Assessed by investigator per RECIST version 1.1.
ORR is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR).
|
Participants will be followed for the duration of treatment, an expected average of 24 weeks.
|
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Progression-free survival (PFS)
Tidsramme: From date of end of treatment until the date of progression, or date of death, or starting date of a new anticancer therapy, assessed up to 100 months.
|
PFS is defined as the times from the date of first dose of BGJ398 to the date of the first documented disease progression, date of death due to any cause or until a new anticancer therapy is initiated, whichever occurs first.
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From date of end of treatment until the date of progression, or date of death, or starting date of a new anticancer therapy, assessed up to 100 months.
|
|
Duration of all Adverse Events (AEs)
Tidsramme: From within 21 days of first treatment to 28 days after treatment discontinuation
|
To characterize the safety and tolerability of oral BGJ398
|
From within 21 days of first treatment to 28 days after treatment discontinuation
|
|
Duration of Serious Advers Events (SAEs)
Tidsramme: From within 21 days of first treatment to 28 days after treatment discontinuation
|
To characterize the safety and tolerability of oral BGJ398
|
From within 21 days of first treatment to 28 days after treatment discontinuation
|
|
Severity of all Adverse Events (AEs)
Tidsramme: From within 21 days of first treatment to 28 days after treatment discontinuation
|
To characterize the safety and tolerability of oral BGJ398
|
From within 21 days of first treatment to 28 days after treatment discontinuation
|
|
Severity of all Serious Advers Events (SAEs)
Tidsramme: From within 21 days of first treatment to 28 days after treatment discontinuation
|
To characterize the safety and tolerability of oral BGJ398
|
From within 21 days of first treatment to 28 days after treatment discontinuation
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. oktober 2012
Primær fullføring (Faktiske)
7. februar 2019
Studiet fullført (Faktiske)
7. februar 2019
Datoer for studieregistrering
Først innsendt
19. september 2012
Først innsendt som oppfylte QC-kriteriene
28. september 2012
Først lagt ut (Anslag)
2. oktober 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. desember 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. desember 2020
Sist bekreftet
1. mars 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CBGJ398X1101
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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