KURZPROTOKOLL ACACIA DN10016 Öffentlicher Titel Phase II Studie zur Effizienz von APD403 in Behandlung mit AC-basierter Chemotherapie Wissenschaftl. Titel Randomised, double-blind, dose-finding phase II study to assess the efficacy of APD403 in the prevention of nausea and vomiting caused by cisplantin- or anthracycline/cyclophosephamide (AC)- based chemotherapy Kurztitel ACACIA DN10016 Studienart multizentrisch, prospektiv, Therapiestudie, randomisiert, Pharma-Studie, doppelblind, mehrarmig Studienphase Phase II Erkrankung HAEMA: Alle hämatologischen Erkrankungen GYN: Alle gynäkologischen Tumoren: Sonstige URO: Alle urogenitalen Tumoren: Sonstige HAEMA: Supportivtherapie THORAX: Nicht kleinzelliges Lungenkarzinom: Erstlinie Einschlusskriterien - Male or female patients >= 18 years of age - Ability and willingness to give written informed consent - Patients scheduled to receive, on day 1 of their chemotherapy, either: (i) a first cisplatin chemotherapy infusion at a dose of 70 mg/m2 (males and females); or (ii) a first infusion of cyclophosphamide at a dose of 500-1500 mg/m2 in combination with either epirubicin at a dose of 60-100 mg/m2 or doxorubicin at a dose of 40-60 mg/m2 (females only) - Karnofsky performance score >= 60% - Adequate cardiac, hepatic and renal function: QTc interval < 500 ms, Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) < 5 x upper limit normal (ULN), Bilirubin < 5 x ULN, Creatinine < 3 x ULN - Adequate haematological function: Haemoglobin >= 8 g/dL, White blood count >= 3.0 x 10^9/L , Platelet count >= 100 x 10^9/L - For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partners use of a condom) during the study and for a period of at least 48 hours afterwards - Patients scheduled to receive, prior to or in the 120 hours after cisplatin or AC, any other chemotherapeutic agent with a high or moderate emetic risk - Patients who have previously received anti-neoplastic chemotherapy - Patients scheduled to receive paclitaxel or docetaxel during the first cycle of their chemotherapy - Patients undergoing abdominal or pelvic irradiation within 48 hours prior to screening or scheduled to receive abdominal or pelvic irradiation between screening and 24 hours after cisplatin or AC administration - Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or confirmed prolactin-dependent breast cancer) or phaeochromocytoma - Patients receiving amisulpride for any indication within the last 2 weeks - Patients who are allergic to amisulpride or any of the excipients of APD403; or to ondansetron, fosaprepitant or dexamethasone; or who would be otherwise considered inappropriate for treatment with any of those agents - Patients with a pre-existing vestibular disorder - Patients being treated with regular anti-emetic therapy including corticosteroids Ausschlusskriterien © Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de Stand: 06.02.2015; Seite 1 von 3 KURZPROTOKOLL ACACIA DN10016 - Patients receiving inhaled corticosteroids, unless started more than one month prior to the expected date of study entry - Patients being treated with medications which could induce torsades de pointes, including Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide; Class III antiarrhythmic agents such as amiodarone and sotalol; and other medications such as bepridil, cisapride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin - Patients being treated with levodopa - Patients receiving benzodiazepines, unless on a stable dose for at least one month prior to the expected date of study entry - Patients with pre-existing nausea or vomiting in the 24 hours before receiving chemotherapy - Patients who are pregnant or breast feeding - Patients with a history of alcohol abuse - Patients with any pre-existing, clinically significant cardiac arrhythmia - Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study - Patients who have participated in another therapeutic study within the previous 28 days Alter 18 Jahre und älter Status Aktiv Beginn der Rekrutierung 29.01.2014 Zentrum im UCT Universitätsklinikum Frankfurt Ansprechpartner Prüfer Brunnberg, Dr. med., Uta Universitätsklinikum Frankfurt/Main Medizinische Klinik II, Hämatologie/Onkologie Theodor-Stern-Kai 7 60590 Frankfurt am Main Tel: +49 (0)69 6301 87146 Fax: +49 (0)69 6301 6089 E-Mail: [email protected] Homepage: http://www.kgu.de/ Stellvertretender Prüfer Sebastian, Dr. med., Martin Universitätsklinikum Frankfurt/Main Medizinische Klinik II, Hämatologie/Onkologie Theodor-Stern-Kai 7 60590 Frankfurt am Main Tel: +49 (0)69 6301-6217 Fax: +49 (0)69 6301-83833 E-Mail: [email protected] Studienzentrale im UCT Studienzentrale der Med. Klinik II, Hämatologie/Onkologie Theodor-Stern-Kai 7 60590 Frankfurt am Main Homepage: http://www.uct- frankfurt.de/content/studien/studienzentralen_und__ambulanzen/haematologie_ onkologie_kgu/index_ger.html © Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de Stand: 06.02.2015; Seite 2 von 3 KURZPROTOKOLL ACACIA DN10016 Studienzentrale Gynäkologie/Brustzentrum Theodor-Stern-Kai 7 60590 Frankfurt am Main Homepage: http://141.2.205.15/zfg/studienzentrale/index.html Studienzentrale der Med. Klinik I, Gastroenterologie/Hepatologie Theodor-Stern-Kai 7 60590 Frankfurt am Main Homepage: http://www.uct- frankfurt.de/content/studien/studienzentralen_und__ambulanzen/studienzentrale n_im_uct/index_ger.html Teilnehmende Kliniken im Medizinische Klinik II, Hämatologie/Onkologie UCT Theodor-Stern-Kai 7 60590 Frankfurt am Main Klinik für Frauenheilkunde und Geburtshilfe Theodor-Stern-Kai 7 60590 Frankfurt am Main Medizinische Klinik I, Gastroenterologie/Hepatologie Theodor-Stern-Kai 7 60590 Frankfurt am Main Sponsoren Central European Society for Anticancer Drug Research Förderer Acacia Pharma Registrierung in anderen Studienregistern EUDRACT 2013-001635-51 Links Studiendokumente zum Download © Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de Stand: 06.02.2015; Seite 3 von 3