LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015118
• Other study ID #: 1199.15
• Secondary ID: AGO-OVAR122008-0
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2009
• Last updated: November 3, 2017
• Start date: November 17, 2009
• Est. completion date: September 15, 2016

Study information

• Verified date: November 2017
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Neoplasms
• Ovarian Neoplasms
• Peritoneal Neoplasms

Intervention

Drug:
• Placebo
comparator to BIBF 1120
• Paclitaxel
Paclitaxel (standard chemo-therapy)
• BIBF 1120
comparison of BIBF 1120 in combination with chemotherapy and placebo in combination with chemotherapy (paclitaxel/carboplatin)
• Carboplatin
Carboplatin (standard chemo-therapy)
• Paclitaxel
Paclitaxel (standard chemo-therapy)
• Carboplatin
Carboplatin (standard chemo-therapy)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

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, 

Outcome

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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