Ovarian Neoplasms Clinical Trial
Official title:
Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer
| Verified date | November 2017 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.
| Status | Completed |
| Enrollment | 1366 |
| Est. completion date | September 15, 2016 |
| Est. primary completion date | April 1, 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: - first diagnosis of histologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer - International Federation of Gynecology and Obstetrics (FIGO) Stages IIB - IV - females, age 18 years or older - life expectancy of at least 6 months - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 - prior surgery, defined as either (a) debulking surgery with maximum surgical effort at cytoreduction with the goal of no residual disease or (b) biopsy or limited surgery in patients with stage IV disease for whom surgical debulking was not considered appropriate, if diagnosis is confirmed by histology and no surgery is planned prior to disease progression (including interval debulking surgery) - patient has given written informed consent which must be consistent with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local legislation - planned application of first dose of chemotherapy after wound healing, but no later than 10 weeks after surgery Exclusion criteria: - histologic diagnosis of a benign or borderline tumour or of a malignant tumour of non-epithelial origin of the ovary, the fallopian tube or the peritoneum - planned surgery within 124 weeks after randomisation in this trial, including interval debulking surgery - clinically relevant non-healing wound, ulcer or bone fracture - clinical symptoms or signs of gastrointestinal obstruction that require parenteral nutrition or hydration - brain metastases - pre-existing sensory or motor neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher, except due to trauma - history of major thromboembolic event - known inherited or acquired bleeding disorder - significant cardiovascular diseases - clinically relevant pericardial effusion - history of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months - inadequate safety laboratory values - serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy, including Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV) - poorly controlled diabetes mellitus or other contraindication to high dose corticosteroid therapy - gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug - other malignancy diagnosed within the past 5 years. In exception to this rule, the following malignancies may be included if adequately treated: non-melanomatous skin cancer, cervical carcinoma in situ, carcinoma in situ of the breast, low risk endometrial cancer - prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, oral targeted therapy, hormonal therapy) - prior systemic cytotoxic chemotherapy - prior treatment with BIBF 1120 or any other angiogenesis inhibitor - prior radiotherapy - serious illness or concomitant non-oncological disease such as neurologic, psychiatric or infectious disease or a laboratory abnormality that may increase the risk associated with study participation or study drug administration - Women of childbearing potential who are sexually active and not using a highly effective method of birth control during the trial and for at least twelve months after the end of active therapy. - pregnancy or breast feeding - psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule - active alcohol or drug abuse - patients unable to comply with the protocol - any contraindications for therapy with paclitaxel or carboplatin - treatment with other investigational drugs or participation in another clinical trial testing a drug within the past four weeks before start of therapy or concomitantly with this trial |
| Country | Name | City | State |
|---|---|---|---|
| Australia | 1199.15.61006 Boehringer Ingelheim Investigational Site | Camperdown | New South Wales |
| Australia | 1199.15.61004 Boehringer Ingelheim Investigational Site | Herston | Queensland |
| Australia | 1199.15.61002 Boehringer Ingelheim Investigational Site | Nedlands | Western Australia |
| Australia | 1199.15.61005 Boehringer Ingelheim Investigational Site | North Terrace | South Australia |
| Australia | 1199.15.61007 Boehringer Ingelheim Investigational Site | Parkville | Victoria |
| Australia | 1199.15.61003 Boehringer Ingelheim Investigational Site | Southe Brisbane | Queensland |
| Australia | 1199.15.61001 Boehringer Ingelheim Investigational Site | Waratah | New South Wales |
| Austria | 1199.15.43003 Boehringer Ingelheim Investigational Site | Graz | |
| Austria | 1199.15.43001 Boehringer Ingelheim Investigational Site | Innsbruck | |
| Austria | 1199.15.43011 Boehringer Ingelheim Investigational Site | Krems | |
| Austria | 1199.15.43007 Boehringer Ingelheim Investigational Site | Kufstein | |
| Austria | 1199.15.43005 Boehringer Ingelheim Investigational Site | Linz | |
| Austria | 1199.15.43010 Boehringer Ingelheim Investigational Site | Salzburg | |
| Austria | 1199.15.43013 Boehringer Ingelheim Investigational Site | Wels | |
| Austria | 1199.15.43002 Boehringer Ingelheim Investigational Site | Wien | |
| Austria | 1199.15.43012 Boehringer Ingelheim Investigational Site | Wien | |
| Belgium | 1199.15.32010 Boehringer Ingelheim Investigational Site | Edegem | |
| Belgium | 1199.15.32012 Boehringer Ingelheim Investigational Site | Hasselt | |
| Belgium | 1199.15.32003 Boehringer Ingelheim Investigational Site | La Louvière | |
| Belgium | 1199.15.32001 Boehringer Ingelheim Investigational Site | Leuven | |
| Belgium | 1199.15.32007 Boehringer Ingelheim Investigational Site | Liège | |
| Belgium | 1199.15.32008 Boehringer Ingelheim Investigational Site | Sint-Niklaas | |
| Canada | 1199.15.11004 Boehringer Ingelheim Investigational Site | Hamilton | Ontario |
| Canada | 1199.15.11008 Boehringer Ingelheim Investigational Site | London | Ontario |
| Canada | 1199.15.11003 Boehringer Ingelheim Investigational Site | Montreal | Quebec |
| Canada | 1199.15.11006 Boehringer Ingelheim Investigational Site | Montreal | Quebec |
| Canada | 1199.15.11001 Boehringer Ingelheim Investigational Site | Sherbrooke | Quebec |
| Canada | 1199.15.11009 Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Canada | 1199.15.11005 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia |
| Czechia | 1199.15.42002 Boehringer Ingelheim Investigational Site | Brno | |
| Czechia | 1199.15.42003 Boehringer Ingelheim Investigational Site | Olomouc | |
| Czechia | 1199.15.42001 Boehringer Ingelheim Investigational Site | Prague | |
| Denmark | 1199.15.45004 Boehringer Ingelheim Investigational Site | Aalborg | |
| Denmark | 1199.15.45002 Boehringer Ingelheim Investigational Site | Herlev | |
| Denmark | 1199.15.45005 Boehringer Ingelheim Investigational Site | Herning | |
| Denmark | 1199.15.45001 Boehringer Ingelheim Investigational Site | Købenahvn Ø | |
| Denmark | 1199.15.45003 Boehringer Ingelheim Investigational Site | Odense C | |
| Finland | 1199.15.35801 Boehringer Ingelheim Investigational Site | Helsinki | |
| Finland | 1199.15.35804 Boehringer Ingelheim Investigational Site | Jyväskylä | |
| Finland | 1199.15.35805 Boehringer Ingelheim Investigational Site | Kuopio | |
| Finland | 1199.15.35803 Boehringer Ingelheim Investigational Site | Oulu | |
| Finland | 1199.15.35802 Boehringer Ingelheim Investigational Site | Tampere | |
| France | 1199.15.33047 Boehringer Ingelheim Investigational Site | Aix-en-Provence | |
| France | 1199.15.33035 Boehringer Ingelheim Investigational Site | Avignon cedex 02 | |
| France | 1199.15.33055 Boehringer Ingelheim Investigational Site | Besançon | |
| France | 1199.15.33004 Boehringer Ingelheim Investigational Site | Bordeaux | |
| France | 1199.15.33003 Boehringer Ingelheim Investigational Site | Bordeaux cedex | |
| France | 1199.15.33006 Boehringer Ingelheim Investigational Site | Caen cedex 5 | |
| France | 1199.15.33025 Boehringer Ingelheim Investigational Site | Clermont-Ferrand cedex | |
| France | 1199.15.33048 Boehringer Ingelheim Investigational Site | Dechy | |
| France | 1199.15.33042 Boehringer Ingelheim Investigational Site | Fréjus | |
| France | 1199.15.33037 Boehringer Ingelheim Investigational Site | La Roche-Sur-Yon cedex 09 | |
| France | 1199.15.33008 Boehringer Ingelheim Investigational Site | Le Mans | |
| France | 1199.15.33009 Boehringer Ingelheim Investigational Site | Lille cedex | |
| France | 1199.15.33020 Boehringer Ingelheim Investigational Site | Lyon | |
| France | 1199.15.33011 Boehringer Ingelheim Investigational Site | Marseille cedex 09 | |
| France | 1199.15.33021 Boehringer Ingelheim Investigational Site | Monaco Cedex | |
| France | 1199.15.33012 Boehringer Ingelheim Investigational Site | Mont-de-Marsan cedex | |
| France | 1199.15.33052 Boehringer Ingelheim Investigational Site | Montpellier cedex 5 | |
| France | 1199.15.33053 Boehringer Ingelheim Investigational Site | Mougins | |
| France | 1199.15.33038 Boehringer Ingelheim Investigational Site | Nancy | |
| France | 1199.15.33013 Boehringer Ingelheim Investigational Site | Nantes cedex 02 | |
| France | 1199.15.33015 Boehringer Ingelheim Investigational Site | Orléans cedex 02 | |
| France | 1199.15.33001 Boehringer Ingelheim Investigational Site | Paris | |
| France | 1199.15.33027 Boehringer Ingelheim Investigational Site | Paris cedex 20 | |
| France | 1199.15.33051 Boehringer Ingelheim Investigational Site | PERIGUEUX Cedex | |
| France | 1199.15.33030 Boehringer Ingelheim Investigational Site | Plerin SUR MER | |
| France | 1199.15.33045 Boehringer Ingelheim Investigational Site | Saint Cloud | |
| France | 1199.15.33033 Boehringer Ingelheim Investigational Site | Saint-Herblain cedex | |
| France | 1199.15.33018 Boehringer Ingelheim Investigational Site | Strasbourg cedex | |
| France | 1199.15.33039 Boehringer Ingelheim Investigational Site | Thonon-Les-Bains | |
| France | 1199.15.33031 Boehringer Ingelheim Investigational Site | Vandoeuvre les Nancy cedex | |
| France | 1199.15.33050 Boehringer Ingelheim Investigational Site | Villejuif Cedex | |
| Germany | 1199.15.49040 Boehringer Ingelheim Investigational Site | Aachen | |
| Germany | 1199.15.49070 Boehringer Ingelheim Investigational Site | Aalen | |
| Germany | 1199.15.49086 Boehringer Ingelheim Investigational Site | Aschaffenburg | |
| Germany | 1199.15.49002 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | 1199.15.49039 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | 1199.15.49041 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | 1199.15.49081 Boehringer Ingelheim Investigational Site | Böblingen | |
| Germany | 1199.15.49004 Boehringer Ingelheim Investigational Site | Bonn | |
| Germany | 1199.15.49042 Boehringer Ingelheim Investigational Site | Bonn | |
| Germany | 1199.15.49071 Boehringer Ingelheim Investigational Site | Bottrop | |
| Germany | 1199.15.49043 Boehringer Ingelheim Investigational Site | Chemnitz | |
| Germany | 1199.15.49005 Boehringer Ingelheim Investigational Site | Dessau | |
| Germany | 1199.15.49006 Boehringer Ingelheim Investigational Site | Detmold | |
| Germany | 1199.15.49007 Boehringer Ingelheim Investigational Site | Dresden | |
| Germany | 1199.15.49067 Boehringer Ingelheim Investigational Site | Dresden | |
| Germany | 1199.15.49008 Boehringer Ingelheim Investigational Site | Düsseldorf | |
| Germany | 1199.15.49009 Boehringer Ingelheim Investigational Site | Ebersberg | |
| Germany | 1199.15.49010 Boehringer Ingelheim Investigational Site | Essen | |
| Germany | 1199.15.49066 Boehringer Ingelheim Investigational Site | Essen | |
| Germany | 1199.15.49089 Boehringer Ingelheim Investigational Site | Essen | |
| Germany | 1199.15.49045 Boehringer Ingelheim Investigational Site | Frankfurt | |
| Germany | 1199.15.49011 Boehringer Ingelheim Investigational Site | Freiburg | |
| Germany | 1199.15.49068 Boehringer Ingelheim Investigational Site | Freiburg | |
| Germany | 1199.15.49083 Boehringer Ingelheim Investigational Site | Freudenstadt | |
| Germany | 1199.15.49046 Boehringer Ingelheim Investigational Site | Fulda | |
| Germany | 1199.15.49012 Boehringer Ingelheim Investigational Site | Fürstenfeldbruck | |
| Germany | 1199.15.49064 Boehringer Ingelheim Investigational Site | Greifswald | |
| Germany | 1199.15.49076 Boehringer Ingelheim Investigational Site | Gütersloh | |
| Germany | 1199.15.49014 Boehringer Ingelheim Investigational Site | Halle/S. | |
| Germany | 1199.15.49015 Boehringer Ingelheim Investigational Site | Hamburg | |
| Germany | 1199.15.49084 Boehringer Ingelheim Investigational Site | Hamburg | |
| Germany | 1199.15.49073 Boehringer Ingelheim Investigational Site | Hanau | |
| Germany | 1199.15.49095 Boehringer Ingelheim Investigational Site | Heidelberg | |
| Germany | 1199.15.49080 Boehringer Ingelheim Investigational Site | Henstedt-Ulzburg | |
| Germany | 1199.15.49047 Boehringer Ingelheim Investigational Site | Hildesheim | |
| Germany | 1199.15.49016 Boehringer Ingelheim Investigational Site | Karlsruhe | |
| Germany | 1199.15.49017 Boehringer Ingelheim Investigational Site | Kiel | |
| Germany | 1199.15.49062 Boehringer Ingelheim Investigational Site | Krefeld | |
| Germany | 1199.15.49018 Boehringer Ingelheim Investigational Site | Landshut | |
| Germany | 1199.15.49019 Boehringer Ingelheim Investigational Site | Lübeck | |
| Germany | 1199.15.49087 Boehringer Ingelheim Investigational Site | Ludwigsburg | |
| Germany | 1199.15.49020 Boehringer Ingelheim Investigational Site | Magdeburg | |
| Germany | 1199.15.49021 Boehringer Ingelheim Investigational Site | Mainz | |
| Germany | 1199.15.49022 Boehringer Ingelheim Investigational Site | Mainz | |
| Germany | 1199.15.49023 Boehringer Ingelheim Investigational Site | Mannheim | |
| Germany | 1199.15.49024 Boehringer Ingelheim Investigational Site | Marburg | |
| Germany | 1199.15.49025 Boehringer Ingelheim Investigational Site | München | |
| Germany | 1199.15.49026 Boehringer Ingelheim Investigational Site | München | |
| Germany | 1199.15.49027 Boehringer Ingelheim Investigational Site | München | |
| Germany | 1199.15.49048 Boehringer Ingelheim Investigational Site | München | |
| Germany | 1199.15.49065 Boehringer Ingelheim Investigational Site | Neumarkt i.d.Opf. | |
| Germany | 1199.15.49029 Boehringer Ingelheim Investigational Site | Offenbach | |
| Germany | 1199.15.49082 Boehringer Ingelheim Investigational Site | Paderborn | |
| Germany | 1199.15.49030 Boehringer Ingelheim Investigational Site | Radebeul | |
| Germany | 1199.15.49061 Boehringer Ingelheim Investigational Site | Ravensburg | |
| Germany | 1199.15.49050 Boehringer Ingelheim Investigational Site | Regensburg | |
| Germany | 1199.15.49051 Boehringer Ingelheim Investigational Site | Rosenheim | |
| Germany | 1199.15.49052 Boehringer Ingelheim Investigational Site | Rostock | |
| Germany | 1199.15.49054 Boehringer Ingelheim Investigational Site | Saalfeld | |
| Germany | 1199.15.49031 Boehringer Ingelheim Investigational Site | Salzgitter | |
| Germany | 1199.15.49055 Boehringer Ingelheim Investigational Site | Solingen | |
| Germany | 1199.15.49092 Boehringer Ingelheim Investigational Site | Stadthagen | |
| Germany | 1199.15.49063 Boehringer Ingelheim Investigational Site | Stendal | |
| Germany | 1199.15.49093 Boehringer Ingelheim Investigational Site | Stralsund | |
| Germany | 1199.15.49033 Boehringer Ingelheim Investigational Site | Stuttgart | |
| Germany | 1199.15.49056 Boehringer Ingelheim Investigational Site | Stuttgart | |
| Germany | 1199.15.49090 Boehringer Ingelheim Investigational Site | Stuttgart | |
| Germany | 1199.15.49079 Boehringer Ingelheim Investigational Site | Suhl | |
| Germany | 1199.15.49034 Boehringer Ingelheim Investigational Site | Traunstein | |
| Germany | 1199.15.49057 Boehringer Ingelheim Investigational Site | Trier | |
| Germany | 1199.15.49035 Boehringer Ingelheim Investigational Site | Tübingen | |
| Germany | 1199.15.49058 Boehringer Ingelheim Investigational Site | Ulm | |
| Germany | 1199.15.49085 Boehringer Ingelheim Investigational Site | Viersen | |
| Germany | 1199.15.49001 Boehringer Ingelheim Investigational Site | Wiesbaden | |
| Germany | 1199.15.49036 Boehringer Ingelheim Investigational Site | Wiesbaden | |
| Germany | 1199.15.49059 Boehringer Ingelheim Investigational Site | Witten | |
| Germany | 1199.15.49037 Boehringer Ingelheim Investigational Site | Wolfsburg | |
| Germany | 1199.15.49060 Boehringer Ingelheim Investigational Site | Worms | |
| Greece | 1199.15.30001 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1199.15.30003 Boehringer Ingelheim Investigational Site | Heraklio | |
| Greece | 1199.15.30002 Boehringer Ingelheim Investigational Site | Nea Kifisia | |
| Greece | 1199.15.30005 Boehringer Ingelheim Investigational Site | Patras | |
| Greece | 1199.15.30004 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Italy | 1199.15.39027 Boehringer Ingelheim Investigational Site | Asti | |
| Italy | 1199.15.39002 Boehringer Ingelheim Investigational Site | Avellino | |
| Italy | 1199.15.39003 Boehringer Ingelheim Investigational Site | Aviano (pn) | |
| Italy | 1199.15.39004 Boehringer Ingelheim Investigational Site | Bari | |
| Italy | 1199.15.39005 Boehringer Ingelheim Investigational Site | Benevento | |
| Italy | 1199.15.39029 Boehringer Ingelheim Investigational Site | Brescia | |
| Italy | 1199.15.39040 Boehringer Ingelheim Investigational Site | Catania | |
| Italy | 1199.15.39007 Boehringer Ingelheim Investigational Site | Catanzaro | |
| Italy | 1199.15.39008 Boehringer Ingelheim Investigational Site | Faenza (RA) | |
| Italy | 1199.15.39039 Boehringer Ingelheim Investigational Site | Ferrara | |
| Italy | 1199.15.39017 Boehringer Ingelheim Investigational Site | Genova | |
| Italy | 1199.15.39037 Boehringer Ingelheim Investigational Site | Lecce | |
| Italy | 1199.15.39009 Boehringer Ingelheim Investigational Site | Mantova | |
| Italy | 1199.15.39033 Boehringer Ingelheim Investigational Site | Meldola (fc) | |
| Italy | 1199.15.39021 Boehringer Ingelheim Investigational Site | Milano | |
| Italy | 1199.15.39028 Boehringer Ingelheim Investigational Site | Milano | |
| Italy | 1199.15.39036 Boehringer Ingelheim Investigational Site | Milano | |
| Italy | 1199.15.39010 Boehringer Ingelheim Investigational Site | Modena | |
| Italy | 1199.15.39026 Boehringer Ingelheim Investigational Site | Monza | |
| Italy | 1199.15.39001 Boehringer Ingelheim Investigational Site | Napoli | |
| Italy | 1199.15.39022 Boehringer Ingelheim Investigational Site | Padova | |
| Italy | 1199.15.39011 Boehringer Ingelheim Investigational Site | Palermo | |
| Italy | 1199.15.39031 Boehringer Ingelheim Investigational Site | Palermo | |
| Italy | 1199.15.39023 Boehringer Ingelheim Investigational Site | Pisa | |
| Italy | 1199.15.39012 Boehringer Ingelheim Investigational Site | Pordenone | |
| Italy | 1199.15.39024 Boehringer Ingelheim Investigational Site | Reggio Emilia | |
| Italy | 1199.15.39013 Boehringer Ingelheim Investigational Site | Roma | |
| Italy | 1199.15.39014 Boehringer Ingelheim Investigational Site | Roma | |
| Italy | 1199.15.39034 Boehringer Ingelheim Investigational Site | Rozzano (MI) | |
| Italy | 1199.15.39030 Boehringer Ingelheim Investigational Site | San Fermo Della Battaglia | |
| Italy | 1199.15.39018 Boehringer Ingelheim Investigational Site | Sondrio | |
| Italy | 1199.15.39006 Boehringer Ingelheim Investigational Site | Tappino (CB) | |
| Italy | 1199.15.39019 Boehringer Ingelheim Investigational Site | Torino | |
| Italy | 1199.15.39020 Boehringer Ingelheim Investigational Site | Torino | |
| Italy | 1199.15.39032 Boehringer Ingelheim Investigational Site | Varese | |
| Netherlands | 1199.15.31009 Boehringer Ingelheim Investigational Site | 's-HERTOGENBOSCH | |
| Netherlands | 1199.15.31005 Boehringer Ingelheim Investigational Site | Amersfoort | |
| Netherlands | 1199.15.31004 Boehringer Ingelheim Investigational Site | Niewegein | |
| Netherlands | 1199.15.31003 Boehringer Ingelheim Investigational Site | Nijmegen | |
| Netherlands | 1199.15.31006 Boehringer Ingelheim Investigational Site | Rotterdam | |
| Netherlands | 1199.15.31002 Boehringer Ingelheim Investigational Site | Utrecht | |
| Norway | 1199.15.47003 Boehringer Ingelheim Investigational Site | Bergen | |
| Norway | 1199.15.47001 Boehringer Ingelheim Investigational Site | Oslo | |
| Norway | 1199.15.47002 Boehringer Ingelheim Investigational Site | Stavanger | |
| Norway | 1199.15.47004 Boehringer Ingelheim Investigational Site | Trondheim | |
| Poland | 1199.15.48003 Boehringer Ingelheim Investigational Site | Gdansk | |
| Poland | 1199.15.48006 Boehringer Ingelheim Investigational Site | Lublin | |
| Poland | 1199.15.48001 Boehringer Ingelheim Investigational Site | Warszawa | |
| Portugal | 1199.15.35102 Boehringer Ingelheim Investigational Site | Coimbra | |
| Portugal | 1199.15.35104 Boehringer Ingelheim Investigational Site | Coimbra | |
| Portugal | 1199.15.35101 Instituto Portugues de Oncologia Lisboa Francisco Gentil | Lisboa | |
| Portugal | 1199.15.35106 Boehringer Ingelheim Investigational Site | Lisboa | |
| Portugal | 1199.15.35108 Boehringer Ingelheim Investigational Site | Lisboa | |
| Portugal | 1199.15.35105 Boehringer Ingelheim Investigational Site | Porto | |
| Portugal | 1199.15.35109 Boehringer Ingelheim Investigational Site | Vila Real | |
| Russian Federation | 1199.15.70006 Boehringer Ingelheim Investigational Site | Barnaul | |
| Russian Federation | 1199.15.70005 Boehringer Ingelheim Investigational Site | Ekaterinburg | |
| Russian Federation | 1199.15.70007 Boehringer Ingelheim Investigational Site | Kazan | |
| Russian Federation | 1199.15.70001 Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | 1199.15.70002 Boehringer Ingelheim Investigational Site | St. Petersburg | |
| Slovakia | 1199.15.42101 Boehringer Ingelheim Investigational Site | Bratislava | |
| Slovakia | 1199.15.42105 Boehringer Ingelheim Investigational Site | Bratislava | |
| Slovakia | 1199.15.42106 Boehringer Ingelheim Investigational Site | Kosice | |
| Slovakia | 1199.15.42103 Boehringer Ingelheim Investigational Site | Nitra | |
| Slovakia | 1199.15.42104 Boehringer Ingelheim Investigational Site | Poprad | |
| Slovakia | 1199.15.42102 Boehringer Ingelheim Investigational Site | Zilina | |
| Spain | 1199.15.34001 Boehringer Ingelheim Investigational Site | Badalona | |
| Spain | 1199.15.34003 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1199.15.34006 Boehringer Ingelheim Investigational Site | Girona | |
| Spain | 1199.15.34004 Boehringer Ingelheim Investigational Site | Lleida | |
| Spain | 1199.15.34002 Boehringer Ingelheim Investigational Site | Madrid | |
| Spain | 1199.15.34010 Boehringer Ingelheim Investigational Site | Madrid | |
| Spain | 1199.15.34005 Boehringer Ingelheim Investigational Site | Palma de Mallorca | |
| Spain | 1199.15.34009 Boehringer Ingelheim Investigational Site | Valencia | |
| Sweden | 1199.15.46005 Boehringer Ingelheim Investigational Site | Linköping | |
| Sweden | 1199.15.46001 Boehringer Ingelheim Investigational Site | Lund | |
| Sweden | 1199.15.46002 Boehringer Ingelheim Investigational Site | Stockholm | |
| Sweden | 1199.15.46004 Boehringer Ingelheim Investigational Site | Umeå | |
| Sweden | 1199.15.46003 Boehringer Ingelheim Investigational Site | Uppsala | |
| Ukraine | 1199.15.38006 Boehringer Ingelheim Investigational Site | Cherkasy | |
| Ukraine | 1199.15.38005 Boehringer Ingelheim Investigational Site | Dnepropetrovsk | |
| Ukraine | 1199.15.38004 Boehringer Ingelheim Investigational Site | Donetsk | |
| Ukraine | 1199.15.38002 Boehringer Ingelheim Investigational Site | Kharkiv | |
| Ukraine | 1199.15.38003 Boehringer Ingelheim Investigational Site | Lviv | |
| United Kingdom | 1199.15.44006 Boehringer Ingelheim Investigational Site | Derby | |
| United Kingdom | 1199.15.44007 Boehringer Ingelheim Investigational Site | Dundee | |
| United Kingdom | 1199.15.44003 Boehringer Ingelheim Investigational Site | Glasgow | |
| United Kingdom | 1199.15.44001 Boehringer Ingelheim Investigational Site | Guildford | |
| United Kingdom | 1199.15.44005 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1199.15.44004 Boehringer Ingelheim Investigational Site | Nottingham | |
| United Kingdom | 1199.15.44002 Boehringer Ingelheim Investigational Site | Poole | |
| United Kingdom | 1199.15.44008 Boehringer Ingelheim Investigational Site | Truro | |
| United States | 1199.15.10013 Boehringer Ingelheim Investigational Site | Abington | Pennsylvania |
| United States | 1199.15.10016 Boehringer Ingelheim Investigational Site | Allentown | Pennsylvania |
| United States | 1199.15.10010 Boehringer Ingelheim Investigational Site | Augusta | Georgia |
| United States | 1199.15.10104 Boehringer Ingelheim Investigational Site | Austin | Texas |
| United States | 1199.15.10100 Boehringer Ingelheim Investigational Site | Bedford | Texas |
| United States | 1199.15.10019 Boehringer Ingelheim Investigational Site | Bismarck | North Dakota |
| United States | 1199.15.10024 Boehringer Ingelheim Investigational Site | Canton | Ohio |
| United States | 1199.15.10012 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina |
| United States | 1199.15.10006 Boehringer Ingelheim Investigational Site | Chattanooga | Tennessee |
| United States | 1199.15.10025 Boehringer Ingelheim Investigational Site | Cleveland | Ohio |
| United States | 1199.15.10029 Boehringer Ingelheim Investigational Site | Cleveland | Ohio |
| United States | 1199.15.10107 Boehringer Ingelheim Investigational Site | Dallas | Texas |
| United States | 1199.15.10108 Boehringer Ingelheim Investigational Site | Dallas | Texas |
| United States | 1199.15.10017 Boehringer Ingelheim Investigational Site | Detroit | Michigan |
| United States | 1199.15.10005 Boehringer Ingelheim Investigational Site | Englewood | Colorado |
| United States | 1199.15.10110 Boehringer Ingelheim Investigational Site | Fort Worth | Texas |
| United States | 1199.15.10102 Boehringer Ingelheim Investigational Site | Greenville | South Carolina |
| United States | 1199.15.10007 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 1199.15.10030 Boehringer Ingelheim Investigational Site | Long Beach | California |
| United States | 1199.15.10011 Boehringer Ingelheim Investigational Site | Louisville | Kentucky |
| United States | 1199.15.10003 Boehringer Ingelheim Investigational Site | Marrero | Louisiana |
| United States | 1199.15.10103 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota |
| United States | 1199.15.10028 Boehringer Ingelheim Investigational Site | New Haven | Connecticut |
| United States | 1199.15.10002 Boehringer Ingelheim Investigational Site | New York | New York |
| United States | 1199.15.10014 Boehringer Ingelheim Investigational Site | Orlando | Florida |
| United States | 1199.15.10021 Boehringer Ingelheim Investigational Site | Portland | Oregon |
| United States | 1199.15.10008 Boehringer Ingelheim Investigational Site | Providence | Rhode Island |
| United States | 1199.15.10001 Boehringer Ingelheim Investigational Site | Santa Rosa | California |
| United States | 1199.15.10004 Boehringer Ingelheim Investigational Site | Savannah | Georgia |
| United States | 1199.15.10105 Boehringer Ingelheim Investigational Site | Spokane | Washington |
| United States | 1199.15.10113 Boehringer Ingelheim Investigational Site | Tucson | Arizona |
| United States | 1199.15.10112 Boehringer Ingelheim Investigational Site | Vancouver | Washington |
| United States | 1199.15.10020 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. | Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment. The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm. |
First drug administration to date of disease progression or death whichever occurs first , upto 29 months | |
| Primary | PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis). | Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm. |
First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months | |
| Secondary | PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint). | Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1. The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm. |
First drug administration to date of disease progression or death whichever occurs first , upto 29 months | |
| Secondary | PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis). | Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm. | First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months | |
| Secondary | Overall Survival | Overall survival is defined as time from randomization to date of death (irrespective of reason). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm. |
First drug administration to date of death until final DBL 26September16, upto 62 months | |
| Secondary | Time to CA-125 Tumour Marker Progression | Time to tumour-marker progression was defined as the time from randomisation until the date when Carbohydrate (cancer) antigen (CA-125) values increased to higher than twice the nadir value. CA-125 >=2 x nadir in case nadir value > Upper limit of normal (ULN) or CA-125 >=2 x ULN in case nadir value <= ULN. | First drug administration until final DBL 26September16, upto 62 months | |
| Secondary | Objective Response Based on Investigator Assessment | Objective tumour response defined as either complete response [CR] or partial response [PR] in patients with at least 1 target lesion reported at baseline | First drug administration until final DBL 26September16, upto 62 months | |
| Secondary | Change in Abdominal/Gastro-intestinal Symptoms Over Time | Change in abdominal/gastro-intestinal over time was calculated on symptoms (scale composite of items 31 to 37 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Module for Ovarian Cancer 28 (EORTC QLQ OV-28). As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/severe level of symptomatology). Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB-III vs IV), and Carboplatin level (AUC5 vs. AUC6). |
First drug administration until final DBL 26September16, upto 62 months | |
| Secondary | Change in Global Health Status/ Quality of Life (QoL) Scale Over Time. | Change in Global Health Status/ Quality of life (QoL) over time was calculated on Global Health Status/QoL scale (composite of items 29 and 30 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) as a general measure. As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/healthy level of functioning). Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB-III vs IV), and Carboplatin level (AUC5 vs. AUC6). |
First drug administration until final DBL 26September16, upto 62 months |
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