A Rollover Protocol of Dacomitinib For Patients In Japan
1. juli 2020 opdateret af: Pfizer
TREATMENT ACCESS PROTOCOL FOR PATIENTS PREVIOUSLY TREATED WITH DACOMITINIB ON A CLINICAL TRIAL IN JAPAN
The purpose of this study to permit continued access to dacomitinib for patients who participated in other dacomitinib monotherapy treatment protocols in Japan and have the potential to derive clinical benefit without unacceptable toxicity from continued dacomitinib treatment.
Studieoversigt
Detaljeret beskrivelse
The intention of the study is to allow continued use of dacomitinib in Japan for patients on closed dacomitinib clinical trials and who continue to experience clinical benefit.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
7
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ishikawa
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Kanazawa City, Ishikawa, Japan, 9208641
- Kanazawa University Hospital
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Okayama
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Kurashiki, Okayama, Japan, 710-8602
- Kurashiki Central Hospital
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Osaka
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Osaka-city, Osaka, Japan, 534-0021
- Osaka City General Hospital Department of Clinical Oncology
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Osakasayama, Osaka, Japan, 589-8511
- Kindai University Hospital
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Shizuoka
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Suntougun, Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
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Tokyo
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Koto-Ku, Tokyo, Japan, 135-8550
- Cancer Institute Hospital,Japanese Foundation for Cancer Research
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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
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients who received dacomitinib on another clinical trial in Japan
- Evidence of a personally signed and dated informed consent document
Exclusion Criteria:
- Patients who meet one or more study withdrawal criteria on the prior study
- Participation in other studies involving other investigational drug(s) during study participation
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
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Dacomitinib
3 dose strengths (45 mg, 30 mg, and 15 mg), continuous oral daily dosing
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Starting at the current dose level in the prior study.
Dose reductions and re-escalations are allowed based on tolerability.
Patients may continue to be treated with dacomitinib on this protocol as long as there is evidence of clinical benefit in the judgment of the investigator.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants Who Were Previously Treated With Dacomitinib on the Parent Study in Japan and Who Got Access to Dacomitinib in This Extension Study
Tidsramme: 4 years
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To allow access to dacomitinib for participants who received dacomitinib on prior studies (A7471009 [NCT01360554] and A7471050 [NCT01774721]) in Japan and who had the potential to derive continued clinical benefit from single-agent dacomitinib treatment without unacceptable toxicity based upon the investigator's judgment.
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4 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Tidsramme: Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
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An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.
TEAEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration.
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Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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)
10. juli 2015
Primær færdiggørelse (Faktiske)
30. maj 2019
Studieafslutning (Faktiske)
30. maj 2019
Datoer for studieregistrering
Først indsendt
3. marts 2015
Først indsendt, der opfyldte QC-kriterier
3. marts 2015
Først opslået (Skøn)
9. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juli 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2020
Sidst verificeret
1. juni 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- A7471055
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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 .