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Iressa Follow-up Trial

29 agosto 2016 aggiornato da: AstraZeneca

Multicenter Open-label, Long-term Safety Trial of Treatment Extension With ZD1839 in Patients Who Have Been Treated in Other ZD1839 Clinical Trials.

The purpose of this study is to assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839 (gefitinib).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

14

Fase

  • Fase 3

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

  • Germania
      • Freiburg, Germania
        • Research Site
      • Gauting, Germania
        • Research Site
      • Großhansdorf, Germania
        • Research Site
      • Hemer, Germania
        • Research Site
      • Jena, Germania
        • Research Site
      • Minden, Germania
        • Research Site
      • Tübingen, Germania
        • 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 18 anni a 99 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Provision of written informed consent to participate in the trial.
  • Female or male aged 18 years and over.
  • Patients with previously diagnosed cancer who have been treated with ZD1839 in a parent ZD1839 clinical trial and may benefit from continuation

Exclusion Criteria:

  • Known severe hypersensitivity to ZD1839
  • Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
  • Withdrawal from a parent ZD1839 trial because of tumor progress

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: Gefitinib (ZD1839)
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
Droga: Gefitinib
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Serious Adverse Events (SAEs)
Lasso di tempo: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)
Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease
Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)
Number of Serious Adverse Events (SAEs) Related to ZD1839
Lasso di tempo: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)
Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.
Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)
Number of Other Adverse Events (AEs)
Lasso di tempo: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)
Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.
Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)
Number of Other Adverse Events (AEs) Related to ZD1839
Lasso di tempo: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)
Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.
Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free Survival (PFS)
Lasso di tempo: From randomization until progression or death (up to 120 months)
Objective disease progressing was assessed using the previous cancer response criteria in the parent ZD1839 trial: ie Southwest Oncology Group (SWOG) tumor response criteria, as a 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions from the overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline; Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase In the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
From randomization until progression or death (up to 120 months)
Overall Survival (OS)
Lasso di tempo: From randomization until death (up to 120 months)
From randomization until death (up to 120 months)

Collaboratori e investigatori

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

Sponsor

AstraZeneca

Investigatori

  • Direttore dello studio: AstraZeneca Germany Medical Director, MD, 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

1 gennaio 2005

Completamento primario (Effettivo)

1 maggio 2015

Completamento dello studio (Effettivo)

1 maggio 2015

Date di iscrizione allo studio

Primo inviato

26 luglio 2006

Primo inviato che soddisfa i criteri di controllo qualità

26 luglio 2006

Primo Inserito (Stima)

27 luglio 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

30 agosto 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 agosto 2016

Ultimo verificato

1 giugno 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1839IL/0555
  • D7913L00008

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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