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Sikkerhed og anti-leukæmisk aktivitet af Vodobatinib (K0706) til behandling af refraktær/intolerant CML svigtende ≥3 tidligere CML-terapier

21. april 2026 opdateret af: Sun Pharma Advanced Research Company Limited

En todelt fase 1/2-undersøgelse til bestemmelse af sikkerhed, tolerabilitet, farmakokinetik og aktivitet af K0706, en ny tyrosinkinasehæmmer (TKI), hos raske forsøgspersoner og hos forsøgspersoner med kronisk myeloid leukæmi (CML) eller Philadelphia-kromosompositiv akut lymfoblastisk Leukæmi (Ph+ ALL)

Fase 1/2 undersøgelse til bestemmelse af sikkerhed, tolerabilitet, farmakokinetik og anti-leukæmisk aktivitet af Vodobatinib (K0706) i behandlingsrefraktær/intolerant CML

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Del A (for raske frivillige) af undersøgelsen er afsluttet

Del B dosis-eskaleringsundersøgelse er afsluttet. Rekruttering til dosisudvidelse er i gang i Indien og Korea

Del C-studie i forsøgspersoner med behandlingsrefraktær/intolerant er på vej globalt.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

124

Fase

  • Fase 2
  • Fase 1

Udvidet adgang

Midlertidigt ikke tilgængelig uden for det kliniske forsøg. Se udvidet adgangsregistrering.

Kontakter og lokationer

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

Studiesteder

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

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

Beskrivelse

Inklusionskriterier:

  • Villig og i stand til at give skriftligt og dateret informeret samtykke
  • Mand eller kvinde i alderen ≥ 18 år
  • Villig og i stand til at overholde de planlagte besøg
  • Eastern Cooperative Oncology Group (ECOG) præstationsstatus på 0, 1 eller 2
  • Forsøgspersoner diagnosticeret med Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, som er resistente og/eller intolerante over for ≥ 3 tidligere TKI'er, hvoraf den ene inkluderer ponatinib (del C).

Ekskluderingskriterier:

  • Tilstedeværelse af T315I (DEL C)
  • Enhver større operation, som bestemt af investigator, inden for 4 uger efter IMP-administration
  • Manglende evne til at gennemgå venepunktur og/eller tolerere venøs adgang
  • Positive eksklusionstests: uringraviditetstest (hvis relevant), HIV, hepatitis B overfladeantigen eller hepatitis C-virus
  • Kendt eller mistænkt historie med betydeligt stofmisbrug som vurderet af efterforskeren
  • Modtaget ethvert andet forsøgsmiddel inden for 30 dage eller en udvaskning på mindst 5 halveringstider, alt efter hvad der er længst af IMP-administration
  • Forsøgspersoner, der er berettiget til potentielt helbredende terapi, der er tilgængelig, herunder hæmatopoietisk stamcelletransplantation
  • En anden primær malignitet inden for de seneste 3 år eller tidligere (bortset fra tilstrækkeligt behandlet ikke-melanom hudkræft eller livmoderhalskræft in situ

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Vodobatinib (K0706) kapsler
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Sun Pharma Advanced Research Company Limited

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.

Generelle publikationer

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)

27. juni 2016

Primær færdiggørelse (Faktiske)

3. januar 2025

Studieafslutning (Faktiske)

3. januar 2025

Datoer for studieregistrering

Først indsendt

10. december 2015

Først indsendt, der opfyldte QC-kriterier

10. december 2015

Først opslået (Anslået)

14. december 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CLR_15_03 V 12 Amendment 12

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

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 Sund (for del A)

Kliniske forsøg med Vodobatinib (K0706) capsules

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Venezuela

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner