KURZPROTOKOLL TRINOVA-3

KURZPROTOKOLL
TRINOVA-3
Öffentlicher Titel
Phase-III Studie zu AMG 386/Paclitaxel/Carboplatin als first-line Behandlung bei
Ovarialkarzinom
Wissenschaftl. Titel
A phase 3 randomized, double blind, placebo-controlled, multi center study of AMG 386
with paclitaxel and carboplatin as first-line treatment of subjects with FIGO stage III-IV
epithelial ovarian, primary peritoneal or fallopian tube cancers
Kurztitel
TRINOVA-3
Studienart
multizentrisch, prospektiv, randomisiert, Pharma-Studie, doppelblind, zweiarmig
Studienphase
Phase III
Erkrankung
GYN: Ovarialkarzinom: Erstlinie
Einschlusskriterien
-
Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian,
primary peritoneal or fallopian tube cancer with an indication for first-line treatment
with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma,
mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma,
sarcoma, mucinous or neuroendocrine histology are excluded
-
Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian,
primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
-
Subjects with FIGO Stage IIIC or IV disease must either:
-
Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within
12 weeks prior to randomization or
-
Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or
AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian
tube cancer
-
ECOG performance status of 0 or 1
-
Adequate bone marrow, renal and hepatic function
-
Prior use of any anticancer therapy or experimental therapy for epithelial ovarian,
primary peritoneal or fallopian tube cancer
-
Previous abdominal and/or pelvic external beam radiotherapy
-
History of central nervous metastasis
-
History of arterial or venous thromboembolism within 12 months prior to
randomization
-
Clinically significant cardiovascular disease within 12 months prior to randomization
Ausschlusskriterien
Alter
18 Jahre und älter
Status
Nachbeobachtung
Beginn der Rekrutierung
10.01.2013
Prüfzentren
Universitätsklinikum Frankfurt
Klinik für Frauenheilkunde und Geburtshilfe
Theodor-Stern-Kai 7
60590 Frankfurt am Main
Dr. Stefan Marcel Loitsch
Tel: 069 6301-6850
Fax: 069 6301-7938
[email protected]
Sponsoren
AMGEN GmbH
Förderer
AMGEN GmbH
Registrierung in anderen
Studienregistern
ClinicalTrials NCT01493505
EUDRACT 2011-001112-53
Therapie
AMG 386
© Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt
Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de
Stand: 01.08.2016; Seite 1 von 1

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