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Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours

30. november 2018 oppdatert av: AstraZeneca

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Patients With Advanced Solid Malignancies

This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

95

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • California
      • Stanford, California, Forente stater, 94305
        • Research Site
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Research Site
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06520
        • Research Site
    • Michigan
      • Detroit, Michigan, Forente stater, 48201
        • Research Site
    • New York
      • New York, New York, Forente stater, 10021
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19111
        • Research Site
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Research Site
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Research Site
  • Frankrike
      • Pierre Benite, Frankrike, 69495
        • Research Site
      • Villejuif, Frankrike, 94805
        • Research Site
  • Italia
      • Napoli, Italia, 80131
        • Research Site
      • Rozzano, Italia, 20089
        • Research Site
  • Nederland
      • Amsterdam, Nederland, 1066 CX
        • Research Site
      • Rotterdam, Nederland, 3015 CE
        • Research Site
  • Spania
      • Badajoz, Spania, 06008
        • Research Site
      • Majadahonda, Spania, 28222
        • Research Site
      • Valencia, Spania, 46010
        • Research Site
      • Valencia, Spania, 46026
        • Research Site
  • Storbritannia
      • Birmingham, Storbritannia, B9 5SS
        • Research Site
      • Edinburgh, Storbritannia, EH4 2XU
        • Research Site
      • Glasgow, Storbritannia, G12 0YN
        • Research Site
      • London, Storbritannia, W1G 6AD
        • Research Site
      • London, Storbritannia, W12 0NN
        • Research Site
      • Manchester, Storbritannia, M20 4BX
        • Research Site
      • Newcastle upon Tyne, Storbritannia, NE7 7DN
        • Research Site
      • Wolverhampton, Storbritannia, WV10 0QP
        • Research Site
  • Tyskland
      • Frankfurt, Tyskland, 60488
        • Research Site
      • Freiburg, Tyskland, 79106
        • Research Site
      • Köln, Tyskland, 50924
        • Research Site

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

25 år til 149 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Minimum life expectancy of 12 weeks
  • The presence of a solid, malignant tumour that is resistance to standard therapies or for which no standard therapies exist
  • In the expansion for the study patients must have a tumour at least 1cm in size that can be measure using a CT or MRI scan, and provide a tumour sample to the sponsor company for testing of FGFR1 and/or 2 amplification
  • Expansion, 5 groups of advanced cancer
  • Solid tumours,FGFR1 and/or FGFR2 gene amplified
  • Squamous NSCLC, FGFR1 gene low & high amplified
  • Gastric adenocarcinoma, including the lower oesophagus/gastro-oesophageal junction, FGFR2 gene low & high amplified
  • Aged at least 25 years

Exclusion Criteria:

  • Treatment with any other chemotherapy, immunotherapy or anticancer agents within 3 weeks before the first dose of study
  • An inability to be able to take the study medication
  • A bad reaction to AZD4547 or any drugs similar to it in structure or class.

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: Part A
Ascending doses of AZD4547 administered orally to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD)
Legemiddel: AZD4547
Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
Legemiddel: AZD4547
Patients start at a dose of 80 mg twice daily, with no washout
Legemiddel: AZD4547
Single dose is followed by washout 5-10 days before multiple dose
Eksperimentell: Part B
Dose expansion phase, at the RD defined in Part A
Legemiddel: AZD4547
Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
Legemiddel: AZD4547
Patients start at a dose of 80 mg twice daily, with no washout
Legemiddel: AZD4547
Single dose is followed by washout 5-10 days before multiple dose
Eksperimentell: Part C
Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A
Legemiddel: AZD4547
Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
Legemiddel: AZD4547
Patients start at a dose of 80 mg twice daily, with no washout
Legemiddel: AZD4547
Single dose is followed by washout 5-10 days before multiple dose

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Patients Who Experienced at Least 1 AE
Tidsramme: AEs are monitored from screenng through to 30 day follow up period
To investigate the safety and tolerability of AZD4547. System organ class (SOC), preferred term (PT), duration and severity all recorded.
AEs are monitored from screenng through to 30 day follow up period
Number of Participants Who Experienced at Least 1 Causally Related AE.
Tidsramme: AEs are continually assessed from screening up to 30 day FU period
To investigate the safety and tolerability of AZD4547. A causally related AE is an AE deemed to be causally related to AZD4547.
AEs are continually assessed from screening up to 30 day FU period
Number of Participants With at Least 1 AE of CTCAE >=G3
Tidsramme: Ongoing up to discontinuation up to 30 day FU.
To investigate the safety and tolerability of AZD4547
Ongoing up to discontinuation up to 30 day FU.
Number of Participants With at Least 1 Causally Related AE of CTCAE >=G3
Tidsramme: Ongoing up to discontinuation up to 30 day FU.
To investigate the safety and tolerability of AZD4547
Ongoing up to discontinuation up to 30 day FU.
Number of Participants Who Experienced at Least One SAE
Tidsramme: Serious Adverse Events (SAEs) are continually assessed from Screening up to the end of the 30 day FU period.
To investigate the safety and tolerability of AZD4547. A SAE (Serious Adverse Event) is and AE (adverse Event) which fulfills one of the following criteria that the PI assesses closely such as results in death, immediately life-threatening, requires hospitalisation or prolongation of, results in significant disability, results in birth defect, may jepardise the patient or require intervention to prevent any of the previous outcomes.
Serious Adverse Events (SAEs) are continually assessed from Screening up to the end of the 30 day FU period.
Number of Participants With at Least 1 Causally Related SAE
Tidsramme: SAEs are continually monitored from screening to end of 30 FU period
To investigate the safety and tolerability of AZD4547: SAEs are assessed and deemed as causally related or not to AZD4547
SAEs are continually monitored from screening to end of 30 FU period

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
AUC(0-infinity)
Tidsramme: PK samples out to 96 hours "0 to 96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
PK samples out to 96 hours "0 to 96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
Tumour Response (Best Objective Response) - Number of Patients With a Confirmed Response of Partial Response (PR) or Confirmed Response (CR)
Tidsramme: Baseline assessment, then assessment every 6 weeks after start of treatment until objective disease progression.
To obtain a preliminary assessment of the anti tumour activity of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1. Objective response = CR + PR; CR=disappearance of all target lesions and PR is >=30% reduction in sum of longest diameter of target lesions
Baseline assessment, then assessment every 6 weeks after start of treatment until objective disease progression.
Cmax (ng/mL)
Tidsramme: PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
Css,Max (ng/mL)
Tidsramme: PK samples out to 96 hours "0-96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
PK samples out to 96 hours "0-96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
AUC,ss(0-infinity)
Tidsramme: PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.

Samarbeidspartnere og etterforskere

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

Sponsor

AstraZeneca

Etterforskere

  • Hovedetterforsker: Fabrice André, Dr, Institut de Cancérologie Gustave Roussy
  • Studieleder: Donal Landers, Dr, AstraZeneca

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)

21. oktober 2009

Primær fullføring (Faktiske)

12. februar 2014

Studiet fullført (Faktiske)

5. mars 2015

Datoer for studieregistrering

Først innsendt

16. september 2009

Først innsendt som oppfylte QC-kriteriene

16. september 2009

Først lagt ut (Anslag)

17. september 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. mars 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. november 2018

Sist bekreftet

1. november 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D2610C00001

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