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A Phase I Study of Oral BGJ398 in Asian Patients

6. december 2020 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

9

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
    • Aichi
      • Nagoya-city, Aichi, Japan, 466-8560
        • Nagoya University Hospital
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East (NCEE)
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Novartis Investigative Site
    • Osaka
      • Sayama, Osaka, Japan, 589 8511
        • Novartis Investigative Site
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
  • Kina
      • Guangzhou, Kina, 510060
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 51000
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Novartis Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: BGJ398

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.
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.
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.
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. oktober 2012

Primær færdiggørelse (Faktiske)

7. februar 2019

Studieafslutning (Faktiske)

7. februar 2019

Datoer for studieregistrering

Først indsendt

19. september 2012

Først indsendt, der opfyldte QC-kriterier

28. september 2012

Først opslået (Skøn)

2. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. december 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CBGJ398X1101

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med BGJ398

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Djibouti

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner