- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02098291
An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma (PC1)
26. marts 2014 opdateret af: Cancer Advances Inc.
Phase II, Open, Single-center Study to Determine the Antibody Response to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma
This study was designed to determine the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advanced pancreatic cancer.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
34
Fase
- Fase 2
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent
- Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study
- Male or female patients over 18 years of age
- Patients with a life expectancy of at least 2 months
- Patients must have given written informed consent
- Patients with a Karnofsky Performance Status score of ≥ 50%
- Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study)
Exclusion Criteria:
- History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix
- Concomitant use or anticipated use in the period of the study of radiotherapy
- Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study
- Use in the past month or concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
- Females who were pregnant, planning to become pregnant or lactating
- Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study
- Haematological indicators:
Haemoglobin <9.5g/dl White blood cell count <3.5 x 109/l Platelets <100 x 109/l
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: G17DT
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pharmacodynamic
Tidsramme: Up to week 16
|
Anti-Gastrin 17 antibodies were determined at baseline (week0) and measured at subsequent visits during the first 16 weeks after the first G17DT injection to determine the effect of jaundice on the ability of patients to generate antibodies.
|
Up to week 16
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Patient Survival
Tidsramme: Up to week 139
|
The vital status was monitored throughout the study and was followed up to the death of the last patient.
|
Up to week 139
|
Number of Participants with Serious and Non-Serious Adverse Events
Tidsramme: Up to week 60
|
Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-exisiting illnesses, were assessed at each visit.
|
Up to week 60
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. april 1999
Primær færdiggørelse (Faktiske)
1. juli 2001
Studieafslutning (Faktiske)
1. februar 2002
Datoer for studieregistrering
Først indsendt
12. marts 2014
Først indsendt, der opfyldte QC-kriterier
26. marts 2014
Først opslået (Skøn)
28. marts 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. marts 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. marts 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PC1
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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 Kræft i bugspytkirtlen
-
Richard HungerMedizinische Hochschule Brandenburg Theodor FontaneAfsluttetVolume-Outcome Relation i Pancreatic Surgery
-
Tianjin Medical University Cancer Institute and...Ikke rekrutterer endnuPDAC - Pancreatic Ductal Adenocarcinoma
-
Sun Yat-sen UniversityRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaKina
-
Cedars-Sinai Medical CenterRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaForenede Stater
-
Azienda Ospedaliera Universitaria Integrata VeronaRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaItalien
-
Azienda Ospedaliera Universitaria Integrata VeronaRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaItalien
-
Washington University School of MedicineUniversity of Oklahoma Medical Center; Northwestern University Chicago... og andre samarbejdspartnereAfsluttet
-
Radboud University Medical CenterDutch Cancer SocietyRekrutteringPDAC - Pancreatic Ductal AdenocarcinomaHolland
-
Imperial College LondonThe Leeds Teaching Hospitals NHS Trust; Sheffield Teaching Hospitals NHS... og andre samarbejdspartnereRekrutteringKræft i bugspytkirtlen | PDAC - Pancreatic Ductal AdenocarcinomaDet Forenede Kongerige
-
Andrei IagaruIkke længere tilgængeligCarcinoide tumorer | Islet Cell (Pancreatic NET) | Andre neuroendokrine tumorerForenede Stater
Kliniske forsøg med G17DT
-
Cancer Advances Inc.AfsluttetKræft i bugspytkirtlen
-
Cancer Advances Inc.AfsluttetKolorektal cancerDet Forenede Kongerige
-
Cancer Advances Inc.Afsluttet
-
Cancer Advances Inc.AfsluttetMavekræftDet Forenede Kongerige
-
Cancer Advances Inc.Afsluttet
-
Cancer Advances Inc.AfsluttetKræft i bugspytkirtlen | Gulsot
-
Cancer Advances Inc.AfsluttetKolorektal cancerDet Forenede Kongerige
-
Cancer Advances Inc.Clinical Project Services; MPS Research UnitAfsluttet
-
Cancer Advances Inc.PPD; ChapelPharma LtdAfsluttet
-
Cancer Advances Inc.Afsluttet