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- Klinische proef NCT00521404
Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
11 maart 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
65
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Alabama
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Birmingham, Alabama, Verenigde Staten
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District of Columbia
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Washington, District of Columbia, Verenigde Staten
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Florida
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Fort Myers, Florida, Verenigde Staten
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Georgia
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Atlanta, Georgia, Verenigde Staten
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Tucker, Georgia, Verenigde Staten, 30084
- Georgia Cancer Specialists
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Illinois
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Decatur, Illinois, Verenigde Staten
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten
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Ohio
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Cincinnati, Ohio, Verenigde Staten
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Tennessee
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Chattanooga, Tennessee, Verenigde Staten
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Nashville, Tennessee, Verenigde Staten
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Texas
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Temple, Texas, Verenigde Staten
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Virginia
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Richmond, Virginia, Verenigde Staten
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: CS-1008 + gemcitabine
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CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly.
Andere namen:
Gemcitabine - 1000mg/meter sq
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
15 augustus 2007
Primaire voltooiing (Werkelijk)
20 augustus 2010
Studie voltooiing (Werkelijk)
20 augustus 2010
Studieregistratiedata
Eerst ingediend
24 augustus 2007
Eerst ingediend dat voldeed aan de QC-criteria
24 augustus 2007
Eerst geplaatst (Schatting)
27 augustus 2007
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 april 2021
Laatste update ingediend die voldeed aan QC-criteria
11 maart 2021
Laatst geverifieerd
1 maart 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Endocriene systeemziekten
- Neoplasmata van het spijsverteringsstelsel
- Endocriene klierneoplasmata
- Alvleesklier Ziekten
- Pancreasneoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Enzymremmers
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Gemcitabine
- Antilichamen
Andere studie-ID-nummers
- CS1008-A-U201
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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