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Sikkerhet og anti-leukemisk aktivitet av Vodobatinib (K0706) for behandling av refraktær/intolerant CML sviktende ≥3 tidligere CML-terapier

21. april 2026 oppdatert av: Sun Pharma Advanced Research Company Limited

En todelt fase 1/2-studie for å bestemme sikkerhet, tolerabilitet, farmakokinetikk og aktivitet til K0706, en ny tyrosinkinasehemmer (TKI), hos friske personer og hos personer med kronisk myeloisk leukemi (CML) eller Philadelphia-kromosompositiv akutt lymfoblastisk Leukemi (Ph+ ALL)

Fase 1/2 studie for å bestemme sikkerhet, tolerabilitet, farmakokinetikk og anti-leukemisk aktivitet av Vodobatinib (K0706) ved behandlingsrefraktær/intolerant CML

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Del A (for friske frivillige) av studien er fullført

Del B dose-eskaleringsstudie er fullført. Rekruttering innen dose-ekspansjon pågår i India og Korea

Del C-studie i forsøkspersoner med behandlingsrefraktær/intolerant meldes inn globalt.

Studietype

Intervensjonell

Registrering (Faktiske)

124

Fase

  • Fase 2
  • Fase 1

Utvidet tilgang

Midlertidig ikke tilgjengelig utenfor den kliniske utprøvingen. Se utvidet tilgangspost.

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Brussels, Belgia, 1200
        • Cliniques Universitaires Saint-Luc
  • Forente stater
    • California
      • Downey, California, Forente stater, 90241
        • The Oncology Institute of Hope and Innovation, Innovative Clinical Research Institute
      • Los Angeles, California, Forente stater, 90024
        • UCLA Hematologic Malignancy Program
    • Florida
      • Jacksonville, Florida, Forente stater, 32224
        • Mayo Clinic
    • Georgia
      • Augusta, Georgia, Forente stater, 30912
        • Board of Regents of the University System of Georgia
    • New York
      • New York, New York, Forente stater, 10065
        • Memorial Sloan Kettering Cancer Center - MAIN
    • Texas
      • Dallas, Texas, Forente stater, 75226
        • Baylor University Medical Center
      • Houston, Texas, Forente stater, 77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Huntsman Cancer Institute University of Utah
  • Frankrike
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, Frankrike, 13273
        • Institut Paoli Calmettes
    • Rhone
      • Lyon, Rhone, Frankrike, 69373
        • Centre Léon Bérard
      • Pierre-Bénite, Rhone, Frankrike, 69495
        • Centre Hospitalier Lyon Sud
  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Hospital
      • Mumbai, Maharashtra, India, 400010
        • Prince Aly Khan Hospital
      • Pune, Maharashtra, India, 411004
        • Sahyadri Specialty Hospital
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625107
        • Meenakshi Mission Hospital & Research Centre
    • West Bengal
      • Kolkata, West Bengal, India, 700156
        • TATA Medical Centre
  • Italia
      • Milan, Italia, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Roma, Italia, 00161
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
      • Roma, Italia, 00144
        • Ospedale Sant'Eugenio
    • Forli - Cesena
      • Meldola, Forli - Cesena, Italia, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
    • Milano
      • Monza, Milano, Italia, 20900
        • Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
  • Romania
      • Bucharest, Romania, 020125
        • Spitalul Clinic Colentina
      • Cluj-Napoca, Romania, 400124
        • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
      • Craiova, Romania, 200143
        • Spitalul Clinic Municipal Filantropia Craiova
  • Spania
      • Barcelona, Spania, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spania, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spania, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spania, 28046
        • Hospital Universitario La Paz
    • Barcelona
      • Badalona, Barcelona, Spania, 08916
        • ICO Badalona - Hospital Universitari Germans Trias i Pujol
  • Storbritannia
    • Greater London
      • London, Greater London, Storbritannia, SE5 9NU
        • King's College Hospital
      • London, Greater London, Storbritannia, W120HS
        • Hammersmith Hospital
  • Sør -Korea
      • Gyeonggi-do, Sør -Korea, 11759
        • Uijeongbu Eulji Medical Center, Eulji University
    • Gyeonggi-do
      • Seoul, Gyeonggi-do, Sør -Korea, 6591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Ungarn
      • Debrecen, Ungarn, 4032
        • Debreceni Egyetem

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

Beskrivelse

Inklusjonskriterier:

  • Villig og i stand til å gi skriftlig og datert informert samtykke
  • Mann eller kvinne i alderen ≥ 18 år
  • Villig og i stand til å overholde de planlagte besøkene
  • Eastern Cooperative Oncology Group (ECOG) ytelsesstatus på 0, 1 eller 2
  • Personer diagnostisert med Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, som er resistente og/eller intolerante overfor ≥ 3 tidligere TKI-er, hvorav én inkluderer ponatinib (del C).

Ekskluderingskriterier:

  • Tilstedeværelse av T315I (DEL C)
  • Enhver større operasjon, som bestemt av etterforskeren, innen 4 uker etter IMP-administrasjon
  • Manglende evne til å gjennomgå venepunktur og/eller tolerere venøs tilgang
  • Positive eksklusjonstester: uringraviditetstester (hvis aktuelt), HIV, hepatitt B overflateantigen eller hepatitt C-virus
  • Kjent eller mistenkt historie med betydelig narkotikamisbruk som bedømt av etterforskeren
  • Mottatt et annet undersøkelsesmiddel innen 30 dager eller en utvasking på minst 5 halveringstider, avhengig av hva som er lengst av IMP-administrasjon
  • Forsøkspersoner som er kvalifisert for potensielt kurativ terapi som er tilgjengelig, inkludert hematopoetisk stamcelletransplantasjon
  • En annen primær malignitet i løpet av de siste 3 årene eller tidligere (bortsett fra tilstrekkelig behandlet ikke-melanom hudkreft eller livmorhalskreft in situ

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Vodobatinib (K0706) kapsler
Legemiddel: Vodobatinib (K0706) capsules

Part A: Oral Vodobatinib (K0706) capsules in single ascending doses.

Part B: Oral Vodobatinib (K0706) capsules in multiple ascending doses, once daily.

Part C: Oral Vodobatinib (K0706) capsules at recommended phase 2 dose of 174 mg, once daily.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Examination of the Safety and Tolerability of Single Oral Doses of K0706
Tidsramme: Approximately 56 ± 2 days
Number of Participants with Adverse Events in Part A
Approximately 56 ± 2 days
To Determine the Maximum Tolerated Dose (MTD) as Determined by Frequency of Dose Limiting Toxicities
Tidsramme: Dose Limiting toxicities observed over a 4 week period
PART B
Dose Limiting toxicities observed over a 4 week period
Incidence and Severity of Treatment Emergent AEs (PART B)
Tidsramme: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Number of Participants with treatment emergent Adverse Events in Part B
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
For CML Subjects in CP at Study Entry
Tidsramme: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C: Proportion of subjects achieving Major Cytogenetic Response [ defined as complete cytogenetic response (CCyR; 0% Ph+metaphases) or partial cytogenetic response (PCyR; 1-35% Ph+ metaphases)] as assessed by conventional Karyotyping of Bone marrow aspirate
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
For CML Subjects in AP at Study Entry
Tidsramme: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C: Proportion of subjects achieving Major Hematologic Response [ defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)] as assessed by complete blood count of peripheral blood sample
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
For CML Subjects in BP at Study Entry
Tidsramme: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C: Proportion of subjects achieving Major Hematologic Response [defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)] as assessed by complete blood count of peripheral blood sample
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To Characterize the Pharmacokinetics (Cmax) of K0706 After Single Oral Doses in Healthy Male Subjects
Tidsramme: Approximately 28 ± 2 days
Part A
Approximately 28 ± 2 days
To Characterize the Pharmacokinetics of K0706 (Cmax) After Single Oral Doses in Fasted and Fed State in Healthy Male Subjects
Tidsramme: Approximately 28 ± 2 days
Part A
Approximately 28 ± 2 days
Pharmacokinetic Profile of K0706 - Cmax [The Maximum (Peak) Observed Drug Concentration After Dose Administration]
Tidsramme: All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
PART B
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
Pharmacokinetic Profile of Vodobatinib (K0706) - Tmax [The Time to Reach Maximum (Peak) Drug Concentration After Dose Administration]
Tidsramme: All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
PART B
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
Pharmacokinetic Profile of Vodobatinib (K0706) - AUC[0-tau] (AUC Over the Dosing Interval of 0-24 Hours).
Tidsramme: All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
PART B
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
In Subjects With CML- CP:Proportion of Subjects Achieving Complete Hematological Response as Assessed by Complete Blood Count of Peripheral Blood Sample
Tidsramme: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In Subjects With CML- CP:Proportion of Subjects Achieving Complete Cytogenetic Response as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
Tidsramme: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In Subjects With CML- CP:Proportion of Subjects Achieving Major Molecular Response as Assessed by BCR-ABL Transcript Levels (BCR-ABL1 Ratio of ≤ 0.1%) in Peripheral Blood Using PCR (Polymerase Chain Reaction)
Tidsramme: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Complete Cytogenetic Response as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
Tidsramme: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Partial Cytogenetic Response (PCyR) as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
Tidsramme: All subjects will be followed up for 60 months from the first dose of K0706
Part C
All subjects will be followed up for 60 months from the first dose of K0706
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Major Molecular Response as Assessed by BCR-ABL Transcript Levels (BCR-ABL1 Ratio of ≤ 0.1%) in Peripheral Blood Using PCR (Polymerase Chain Reaction)
Tidsramme: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Time to Major Cytogenetic Response (MCyR): Time to MCyR is the Time From First Dose to First MCyR (0-35% Ph+ Metaphases); Computed Only for CML-CP Subjects Who Achieved MCyR
Tidsramme: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C; Time to response was calculated as time from date of first dose to date of first occurrence of best response
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Time to Major Molecular Response : Time to MMR is the Time From First Dose to First MMR (BCR-ABL1 Ratio of ≤ 0.1%) Computed Only for CML-CP Subjects Who Achieved MMR
Tidsramme: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C; Time to response was calculated as time from date of first dose to date of first occurrence of best response
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In All Subjects Progression Free Survival (PFS)
Tidsramme: All subjects will be followed up at 12, 24, 36 months from the first dose of K0706 and beyond, until intolerance, disease progression or subject withdrawal from the study.
PART C
All subjects will be followed up at 12, 24, 36 months from the first dose of K0706 and beyond, until intolerance, disease progression or subject withdrawal from the study.
In All Subjects Overall Survival (OS)
Tidsramme: All subjects will be followed up at 12, 24, 36 months from the first dose of K0706 and beyond, until intolerance, disease progression or subject withdrawal from the study.
PART C
All subjects will be followed up at 12, 24, 36 months from the first dose of K0706 and beyond, until intolerance, disease progression or subject withdrawal from the study.
Incidence and Severity of Treatment Emergent AEs (PART C)
Tidsramme: All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Number of Participants with treatment emergent Adverse Events in Part C
All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Pharmacokinetic Profile of K0706 - Cmax [The Maximum (Peak) Observed Drug Concentration After Dose Administration]
Tidsramme: All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
PART C
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
Pharmacokinetic Profile of Vodobatinib (K0706) - Tmax [The Time to Reach Maximum (Peak) Drug Concentration After Dose Administration]
Tidsramme: All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
PART C
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
To Characterize the Pharmacokinetics (AUC(0-inf)) of K0706 After Single Oral Doses in Healthy Male Subjects
Tidsramme: Approximately 28 ± 2 days
Part A
Approximately 28 ± 2 days
To Characterize the Pharmacokinetics of K0706 (AUC(0-inf)) After Single Oral Doses in Fasted and Fed State in Healthy Male Subjects
Tidsramme: Approximately 28 ± 2 days
Part A
Approximately 28 ± 2 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sun Pharma Advanced Research Company Limited

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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)

27. juni 2016

Primær fullføring (Faktiske)

3. januar 2025

Studiet fullført (Faktiske)

3. januar 2025

Datoer for studieregistrering

Først innsendt

10. desember 2015

Først innsendt som oppfylte QC-kriteriene

10. desember 2015

Først lagt ut (Antatt)

14. desember 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CLR_15_03 V 12 Amendment 12

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere