Trial Type
First-Line-Therapy (Metastatic Disease/Hematology)
Description for experts
Window-of-opportunity proof-of-concept, non-randomized, open-label phase II trial of Olaparib given alone (cohort A) or in
combination with Durvalumab (cohort B) prior to primary debulking
surgery in histologically proven high-grade epithelial ovarian
cancer (EOC)
Description for laymen
Window-of-opportunity proof-of-concept, non-randomized, open-label phase II trial of Olaparib given alone (cohort A) or in
combination with Durvalumab (cohort B) prior to primary debulking
surgery in histologically proven high-grade epithelial ovarian
cancer (EOC)
JSON Data
{
"short_title": "AGO-Ovar 27",
"data_mode": "900",
"data_mode_number": "000002360",
"official_title": "WoO: Window of Opportunity (Gelegenheitsfenster) Studie zu Olaparib und Durvalumab in histologisch nachgewiesenem EOC",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "neoadjuvant",
"therapielinie_value": "first",
"ctgov_number": null,
"eudract_number": "2020-005101-12",
"general_contact_email": "studiensekretariat.gyn@ukdd.de",
"general_contact_phone": "+49 351-4584202",
"hauptpruefer_dd_name": "Prof. Dr. med. Pauline Wimberger",
"description_laie_de": "Es handelt sich um eine nichtrandomisierte, open-label Phase II Studie, in der die Machbarkeit einer Behandlung mit Olaparib als Monotherapie oder in Kombination mit Durvalumab w\u00e4hrend des Zeitfensters (\u201eWindow-of-Opportunity\u201c) zwischen der Verdachtsdiagnose bzw. der diagnostischen Bauchspiegelung und der prim\u00e4ren Operation zur Tumorentfernung untersucht wird. Dar\u00fcber hinaus soll untersucht werden, ob \u00c4nderungen im Profil der zirkulierenden Tumor-DNA (ctDNA) w\u00e4hrend dieser Behandlungsphase zur Vorhersage einer zielgerichteten Therapie f\u00fcr individuelle Patientinnen geeignet sind.",
"description_laie_en": "Window-of-opportunity proof-of-concept, non-randomized, open-label phase II trial of Olaparib given alone (cohort A) or in \r\ncombination with Durvalumab (cohort B) prior to primary debulking \r\nsurgery in histologically proven high-grade epithelial ovarian \r\ncancer (EOC)",
"description_expert_de": "Window-of-opportunity \u2013 AGO-OVAR 27 ist eine nichtrandomisierte, open-label Phase Machbarkeitsstudie zur Verabreichung von Olaparib als Monotherapie (Kohorte A) oder in Kombination mit Durvalumab (Kohorte B) vor der prim\u00e4ren Tumordebulking-Operation beim histologisch nachgewiesenen hochgradigen epithelialen Ovarialkarzinom (EOC).",
"description_expert_en": "Window-of-opportunity proof-of-concept, non-randomized, open-label phase II trial of Olaparib given alone (cohort A) or in \r\ncombination with Durvalumab (cohort B) prior to primary debulking \r\nsurgery in histologically proven high-grade epithelial ovarian \r\ncancer (EOC)",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "II",
"main_cat_id": 3,
"sub_cat_id": 15
}
