- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00357734
Iressa Follow-up Trial
29. august 2016 opdateret af: 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).
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
14
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Freiburg, Tyskland
- Research Site
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Gauting, Tyskland
- Research Site
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Großhansdorf, Tyskland
- Research Site
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Hemer, Tyskland
- Research Site
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Jena, Tyskland
- Research Site
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Minden, Tyskland
- Research Site
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Tübingen, Tyskland
- Research Site
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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
18 år til 99 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
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: Gefitinib (ZD1839)
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
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ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Serious Adverse Events (SAEs)
Tidsramme: 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)
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Number of Serious Adverse Events (SAEs) Related to ZD1839
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Progression-free Survival (PFS)
Tidsramme: 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.
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From randomization until progression or death (up to 120 months)
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Overall Survival (OS)
Tidsramme: From randomization until death (up to 120 months)
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From randomization until death (up to 120 months)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: AstraZeneca Germany Medical Director, MD, 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
1. januar 2005
Primær færdiggørelse (Faktiske)
1. maj 2015
Studieafslutning (Faktiske)
1. maj 2015
Datoer for studieregistrering
Først indsendt
26. juli 2006
Først indsendt, der opfyldte QC-kriterier
26. juli 2006
Først opslået (Skøn)
27. juli 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. august 2016
Sidst verificeret
1. juni 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1839IL/0555
- D7913L00008
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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