Trial Type
First-Line-Therapy (Metastatic Disease/Hematology)
Description for experts
The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxeland gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomizedpatients.
A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial
of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in
Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma
Description for laymen
A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial
of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in
Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma
JSON Data
{
"short_title": "ARCUS PRISM-1 ",
"data_mode": "900",
"data_mode_number": "000002479",
"official_title": "A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "first",
"ctgov_number": "NCT06608927",
"eudract_number": null,
"general_contact_email": "oncostudy@ukdd.de",
"general_contact_phone": "+49 351-4587666",
"hauptpruefer_dd_name": "Prof. Dr. med. Gunnar Folprecht",
"description_laie_de": "Eine randomisierte, placebokontrollierte, doppelblinde, multizentrische Phase-3-Studie \r\nvon Quemliclustat und Chemotherapie im Vergleich zu Placebo und Chemotherapie bei \r\nPatienten mit therapienaivem metastasiertem duktalen Adenokarzinom der Bauchspeicheldr\u00fcse",
"description_laie_en": "A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial \r\nof Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in \r\nPatients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma",
"description_expert_de": "Eine randomisierte, placebokontrollierte, doppelblinde, multizentrische Phase-3-Studie \r\nvon Quemliclustat und Chemotherapie im Vergleich zu Placebo und Chemotherapie bei \r\nPatienten mit therapienaivem metastasiertem duktalen Adenokarzinom der Bauchspeicheldr\u00fcse",
"description_expert_en": "The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxeland gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomizedpatients.\r\nA Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial \r\nof Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in \r\nPatients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "III",
"main_cat_id": 2,
"sub_cat_id": 4
}
