- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00602745
S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen (S-1 Pancreas)
A Multicenter, Open-Label, Randomized Study Comparing Efficacy and Safety of S-1 as Single Agent Versus 5-FU Bolus for the Treatment of Patients With Metastatic Pancreatic Cancer Previously Treated With a Gemcitabine-Based Regimen
The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy.
The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
-
Sao Paulo, Brasilien
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Laval, Canada
- Sanofi-Aventis Administrative Office
-
-
-
-
-
San José, Costa Rica
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Horsholm, Danmark
- Sanofi-Aventis Administrative Office
-
-
-
-
New Jersey
-
Bridgewater, New Jersey, Forenede Stater, 08807
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Paris, Frankrig
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Athens, Grækenland
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Mixco, Guatemala
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Netanya, Israel
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Ocean Business Plaza, Panama
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Lima, Peru
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Bucuresti, Rumænien
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Bromma, Sverige
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Midrand, Sydafrika
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Megrine, Tunesien
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Budapest, Ungarn
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Vienna, Østrig
- Sanofi-Aventis Administrative Office
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine pancreas
- Metastatic disease previously treated with a gemcitabine-based regimen
Exclusion Criteria:
- Locally advanced disease
- More than one prior chemotherapy-line for advanced pancreatic disease
- Prior treatment with fluoropyrimidines for advanced pancreatic cancer
- Eastern Cooperative Oncology Group (ECOG) performance status >or= 2
- Poor kidney, liver or bone marrow functions
- Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
- Unable to swallow capsules
- Hypersensitivity history to any of the constituents of the study medications or fluoropyrimidines
- Concurrent participation in another clinical trial or treatment with any other anticancer therapy
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 5-Fluorouracil
|
intravenous bolus
|
Eksperimentel: S-1
|
oral administration
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Overall Survival
Tidsramme: study period
|
study period
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Progressionsfri overlevelse
Tidsramme: hver 6. uge
|
hver 6. uge
|
Overall Response Rate according to RECIST criteria
Tidsramme: every 6 weeks
|
every 6 weeks
|
Clinical Benefit assessed by Time to Symptoms Worsening (TTSW)
Tidsramme: every 6 weeks
|
every 6 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Patologiske processer
- Neoplasmer efter sted
- Sygdomme i det endokrine system
- Neoplasmer i fordøjelsessystemet
- Neoplasmer i endokrine kirtler
- Neoplastiske processer
- Pancreassygdomme
- Neoplasmer
- Neoplasma Metastase
- Bugspytkirtel neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Fluorouracil
Andre undersøgelses-id-numre
- EFC10203
- S-1 - FI
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 .
Kliniske forsøg med Neoplasma Metastase
-
Guangzhou First People's HospitalAfsluttet
Kliniske forsøg med 5-Fluorouracil
-
The Netherlands Cancer InstituteAfsluttet
-
The Netherlands Cancer InstituteAfsluttet
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkendtPlanocellulært karcinom i hoved og halsKina
-
The Cleveland ClinicNational Cancer Institute (NCI)AfsluttetAktinisk keratose | Organ- eller vævstransplantation; KomplikationerForenede Stater
-
Singapore National Eye CentreSingapore Eye Research Institute; Nanchang UniversityAfsluttetGrøn stær | Sårheling | TrabekulektomiSingapore
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AfsluttetKolorektal cancer | Metastatisk kræftForenede Stater
-
UNC Lineberger Comprehensive Cancer CenterAktiv, ikke rekrutterendeHIV-infektioner | CIN 2/3Kenya
-
University of AleppoAleppo University HospitalRekrutteringBasalcellekarcinom | BCCSyrien Arabiske Republik
-
Hong Kong Nasopharyngeal Cancer Study Group LimitedThe Hong Kong Anti-Cancer Society; hong Kong Cancer FundAfsluttet