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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 mis à jour par: 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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

95

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

25 ans à 149 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Patients Who Experienced at Least 1 AE
Délai: 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.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
AUC(0-infinity)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

AstraZeneca

Les enquêteurs

  • Chercheur principal: Fabrice André, Dr, Institut de Cancerologie Gustave Roussy
  • Directeur d'études: Donal Landers, Dr, AstraZeneca

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

21 octobre 2009

Achèvement primaire (Réel)

12 février 2014

Achèvement de l'étude (Réel)

5 mars 2015

Dates d'inscription aux études

Première soumission

16 septembre 2009

Première soumission répondant aux critères de contrôle qualité

16 septembre 2009

Première publication (Estimation)

17 septembre 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 mars 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 novembre 2018

Dernière vérification

1 novembre 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • D2610C00001

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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