- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00521404
Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
11. března 2021 aktualizováno: Daiichi Sankyo, Inc.
Phase 2 Multicenter, Open-Label Study of CS-1008, A Humanized Monoclonal Antibody Targeting Death Receptor 5 (DR5), In Combination With Gemcitabine in Chemotherapy Naive Subjects With Unresectable or Metastatic Pancreatic Cancer
Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
Primary Objective:
- To evaluate the efficacy of CS-1008 administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer, based on the progression-free survival at 16 weeks.
Secondary Objectives:
- To evaluate the efficacy of CS-1008 administered in combination with gemcitabine on overall progression-free survival rate, objective response rate, duration of response, and overall survival.
- To determine the pharmacokinetics of BIP CS-1008 and DSC CS-1008.
- To study potential biomarkers of CS-1008 activity
- To assess possible human anti-human antibody formation after exposure to CS-1008
- To evaluate the safety profile of CS-1008 when administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer.
Typ studie
Intervenční
Zápis (Aktuální)
65
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Alabama
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Birmingham, Alabama, Spojené státy
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District of Columbia
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Washington, District of Columbia, Spojené státy
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Florida
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Fort Myers, Florida, Spojené státy
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Georgia
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Atlanta, Georgia, Spojené státy
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Tucker, Georgia, Spojené státy, 30084
- Georgia Cancer Specialists
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Illinois
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Decatur, Illinois, Spojené státy
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Minnesota
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Minneapolis, Minnesota, Spojené státy
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Ohio
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Cincinnati, Ohio, Spojené státy
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Tennessee
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Chattanooga, Tennessee, Spojené státy
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Nashville, Tennessee, Spojené státy
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Texas
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Temple, Texas, Spojené státy
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Virginia
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Richmond, Virginia, Spojené státy
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Histologically or cytologically confirmed resectable or metastatic pancreatic cancer; not previously treated with chemotherapy; measurable disease; 18 years of age or older
Exclusion Criteria:
- Anticipation of need for major surgery or radiation therapy during the study
- Heart Disease exclusions: myocardial infarction or unstable angina within the past 6 months; severe or unstable angina pectoris within the past 6 months; coronary or peripheral artery bypass graft within the past 6 mo., etc.
- Clinically significant active infection or history of HIV
- Partial or complete bowel obstruction
- Poorly controlled psychiatric illness
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: CS-1008 + gemcitabine
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CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly.
Ostatní jména:
Gemcitabine - 1000mg/meter sq
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Progression-Free Survival Rate at 16 Weeks Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
Časové okno: Baseline to the date of disease progression or death due to any cause (whichever occurs first), up to 16 weeks post dose.
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Progression-free survival rate (PFS) was defined as the time from the date of the first administration of the study drug (Day 1) to the date of the first objective documentation of disease progression or death resulting from any cause, whichever came first at 16 weeks post-treatment with CS-1008.
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Baseline to the date of disease progression or death due to any cause (whichever occurs first), up to 16 weeks post dose.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Kaplan-Meier (Non-Parametric) Analysis of Progression-Free Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
Časové okno: Baseline up to date of disease progression or death due to any cause (whichever occurs first), up to approximately 36 months post dose.
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PFS (Progression-free survival) was defined as the time from the date of the first administration of study drug (Day 1) to the date of the first objective documentation of disease progression or death resulting from any cause, whichever came first.
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Baseline up to date of disease progression or death due to any cause (whichever occurs first), up to approximately 36 months post dose.
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Overall Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
Časové okno: Baseline to death due to any cause, up to approximately 36 months post dose.
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OS (Overall Survival) was defined as the time from the date of the first administration of study drug (Day 1) to the date of death.
If there was no death reported for a subject before the cut-off date for overall survival analysis, overall survival was censored at the last contact date at which the subject was known to be alive.
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Baseline to death due to any cause, up to approximately 36 months post dose.
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Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
Časové okno: Baseline to up to date of first documented objective response or disease progression (whichever occurs first), up to approximately 36 months post dose.
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The best overall response the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], unconfirmed CR, unconfirmed PR, stable disease [SD], and progressive disease[PD]) among all overall responses recorded from the start of treatment until the subject withdrew from the study.
If there was no tumor assessment after the first infusion of study drug and no clinical disease progression recorded, the best overall response was classified as Unknown.
CR was defined as the disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, PD was defined as at least a 20% increase in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease PD according to RECIST guideline (version 1.1).
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Baseline to up to date of first documented objective response or disease progression (whichever occurs first), up to approximately 36 months post dose.
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Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term
Časové okno: Baseline up to 30 days post last dose, up to approximately 36 months post dose.
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A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that: emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment or worsens in severity during treatment relative to the pre-treatment state when the AE was continuous.
The AEs with an onset date on Day 1 (the date on which the first dose of study medication was administered) were counted as a TEAE.
An AE that occurred more than 30 days after the last dose of study medication was not included as a TEAE unless it was considered drug-related.
A TEAE was considered related to CS-1008 or gemcitabine if the investigator considered the event as possibly, probably, or definitely related to treatment, or if the investigator's assessment of the relationship was unknown.
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Baseline up to 30 days post last dose, up to approximately 36 months post dose.
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Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term
Časové okno: Baseline up to 30 days post last dose, up to approximately 36 months post dose.
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A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that: emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment or worsens in severity during treatment relative to the pre-treatment state when the AE was continuous.
The AEs with an onset date on Day 1 (the date on which the first dose of study medication was administered) were counted as a TEAE.
An AE that occurred more than 30 days after the last dose of study medication was not included as a TEAE unless it was considered drug-related.
A TEAE was considered related to CS-1008 or gemcitabine if the investigator considered the event as possibly, probably, or definitely related to treatment, or if the investigator's assessment of the relationship was unknown.
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Baseline up to 30 days post last dose, up to approximately 36 months post dose.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
15. srpna 2007
Primární dokončení (Aktuální)
20. srpna 2010
Dokončení studie (Aktuální)
20. srpna 2010
Termíny zápisu do studia
První předloženo
24. srpna 2007
První předloženo, které splnilo kritéria kontroly kvality
24. srpna 2007
První zveřejněno (Odhad)
27. srpna 2007
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. dubna 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
11. března 2021
Naposledy ověřeno
1. března 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci trávicího systému
- Novotvary
- Novotvary podle místa
- Onemocnění endokrinního systému
- Novotvary trávicího systému
- Novotvary endokrinních žláz
- Onemocnění slinivky břišní
- Novotvary pankreatu
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Antiinfekční látky
- Antivirová činidla
- Inhibitory enzymů
- Antimetabolity, Antineoplastika
- Antimetabolity
- Antineoplastická činidla
- Imunosupresivní látky
- Imunologické faktory
- Gemcitabin
- Protilátky
Další identifikační čísla studie
- CS1008-A-U201
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na CS-1008 (humanized anti-DR5 antibody)
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Daiichi Sankyo, Inc.DokončenoLymfom | MalignitySpojené státy