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

30 novembre 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

95

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 25 anni a 149 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Patients Who Experienced at Least 1 AE
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
AUC(0-infinity)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Investigatori

  • Investigatore principale: Fabrice André, Dr, Institut de Cancérologie Gustave Roussy
  • Direttore dello studio: Donal Landers, Dr, AstraZeneca

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 ottobre 2009

Completamento primario (Effettivo)

12 febbraio 2014

Completamento dello studio (Effettivo)

5 marzo 2015

Date di iscrizione allo studio

Primo inviato

16 settembre 2009

Primo inviato che soddisfa i criteri di controllo qualità

16 settembre 2009

Primo Inserito (Stima)

17 settembre 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 marzo 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 novembre 2018

Ultimo verificato

1 novembre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D2610C00001

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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