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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

95

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

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

25 år til 149 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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: 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)
Medicin: AZD4547
Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
Medicin: AZD4547
Patients start at a dose of 80 mg twice daily, with no washout
Medicin: AZD4547
Single dose is followed by washout 5-10 days before multiple dose
Eksperimentel: Part B
Dose expansion phase, at the RD defined in Part A
Medicin: AZD4547
Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
Medicin: AZD4547
Patients start at a dose of 80 mg twice daily, with no washout
Medicin: AZD4547
Single dose is followed by washout 5-10 days before multiple dose
Eksperimentel: Part C
Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A
Medicin: AZD4547
Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
Medicin: AZD4547
Patients start at a dose of 80 mg twice daily, with no washout
Medicin: AZD4547
Single dose is followed by washout 5-10 days before multiple dose

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Efterforskere

  • Ledende efterforsker: Fabrice André, Dr, Institut de Cancerologie Gustave Roussy
  • Studieleder: Donal Landers, Dr, AstraZeneca

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)

21. oktober 2009

Primær færdiggørelse (Faktiske)

12. februar 2014

Studieafslutning (Faktiske)

5. marts 2015

Datoer for studieregistrering

Først indsendt

16. september 2009

Først indsendt, der opfyldte QC-kriterier

16. september 2009

Først opslået (Skøn)

17. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. november 2018

Sidst verificeret

1. november 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D2610C00001

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Kliniske forsøg med AZD4547

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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