Ovarian NeoplasmsPhase 3NCT01015118

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

A Phase 3 study testing Paclitaxel, BIBF 1120 and Carboplatin in people with Ovarian Neoplasms and Peritoneal Neoplasms, run by Boehringer Ingelheim at 281 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Ovarian Neoplasms, Peritoneal Neoplasms
What is being tested?: Paclitaxel, BIBF 1120 and Carboplatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,366 participants
Where: 281 sitesin 22 countries
Study dates: 17 Nov 2009to 15 Sep 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 28Show fewer

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

Trial locations and contacts

281 sites in 22 countries.

Country

City, postcode or hospital

281 sites in 22 countries

Germany78 sites

1199.15.49040 Boehringer Ingelheim Investigational Site
Aachen
1199.15.49070 Boehringer Ingelheim Investigational Site
Aalen
1199.15.49086 Boehringer Ingelheim Investigational Site
Aschaffenburg
1199.15.49002 Boehringer Ingelheim Investigational Site
Berlin
1199.15.49039 Boehringer Ingelheim Investigational Site
Berlin
1199.15.49041 Boehringer Ingelheim Investigational Site
Berlin
1199.15.49081 Boehringer Ingelheim Investigational Site
Böblingen
1199.15.49004 Boehringer Ingelheim Investigational Site
Bonn
1199.15.49042 Boehringer Ingelheim Investigational Site
Bonn
1199.15.49071 Boehringer Ingelheim Investigational Site
Bottrop
1199.15.49043 Boehringer Ingelheim Investigational Site
Chemnitz
1199.15.49005 Boehringer Ingelheim Investigational Site
Dessau
1199.15.49006 Boehringer Ingelheim Investigational Site
Detmold
1199.15.49007 Boehringer Ingelheim Investigational Site
Dresden
1199.15.49067 Boehringer Ingelheim Investigational Site
Dresden
1199.15.49008 Boehringer Ingelheim Investigational Site
Düsseldorf
1199.15.49009 Boehringer Ingelheim Investigational Site
Ebersberg
1199.15.49010 Boehringer Ingelheim Investigational Site
Essen
1199.15.49066 Boehringer Ingelheim Investigational Site
Essen
1199.15.49089 Boehringer Ingelheim Investigational Site
Essen
1199.15.49045 Boehringer Ingelheim Investigational Site
Frankfurt
1199.15.49011 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1199.15.49068 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1199.15.49083 Boehringer Ingelheim Investigational Site
Freudenstadt
1199.15.49046 Boehringer Ingelheim Investigational Site
Fulda
1199.15.49012 Boehringer Ingelheim Investigational Site
Fürstenfeldbruck
1199.15.49064 Boehringer Ingelheim Investigational Site
Greifswald
1199.15.49076 Boehringer Ingelheim Investigational Site
Gütersloh
1199.15.49014 Boehringer Ingelheim Investigational Site
Halle/S.
1199.15.49015 Boehringer Ingelheim Investigational Site
Hamburg
1199.15.49084 Boehringer Ingelheim Investigational Site
Hamburg
1199.15.49073 Boehringer Ingelheim Investigational Site
Hanau
1199.15.49095 Boehringer Ingelheim Investigational Site
Heidelberg
1199.15.49080 Boehringer Ingelheim Investigational Site
Henstedt-Ulzburg
1199.15.49047 Boehringer Ingelheim Investigational Site
Hildesheim
1199.15.49016 Boehringer Ingelheim Investigational Site
Karlsruhe
1199.15.49017 Boehringer Ingelheim Investigational Site
Kiel
1199.15.49062 Boehringer Ingelheim Investigational Site
Krefeld
1199.15.49018 Boehringer Ingelheim Investigational Site
Landshut
1199.15.49019 Boehringer Ingelheim Investigational Site
Lübeck
1199.15.49087 Boehringer Ingelheim Investigational Site
Ludwigsburg
1199.15.49020 Boehringer Ingelheim Investigational Site
Magdeburg
1199.15.49021 Boehringer Ingelheim Investigational Site
Mainz
1199.15.49022 Boehringer Ingelheim Investigational Site
Mainz
1199.15.49023 Boehringer Ingelheim Investigational Site
Mannheim
1199.15.49024 Boehringer Ingelheim Investigational Site
Marburg
1199.15.49025 Boehringer Ingelheim Investigational Site
München
1199.15.49026 Boehringer Ingelheim Investigational Site
München
1199.15.49027 Boehringer Ingelheim Investigational Site
München
1199.15.49048 Boehringer Ingelheim Investigational Site
München
1199.15.49065 Boehringer Ingelheim Investigational Site
Neumarkt in der Oberpfalz
1199.15.49029 Boehringer Ingelheim Investigational Site
Offenbach
1199.15.49082 Boehringer Ingelheim Investigational Site
Paderborn
1199.15.49030 Boehringer Ingelheim Investigational Site
Radebeul
1199.15.49061 Boehringer Ingelheim Investigational Site
Ravensburg
1199.15.49050 Boehringer Ingelheim Investigational Site
Regensburg
1199.15.49051 Boehringer Ingelheim Investigational Site
Rosenheim
1199.15.49052 Boehringer Ingelheim Investigational Site
Rostock
1199.15.49054 Boehringer Ingelheim Investigational Site
Saalfeld
1199.15.49031 Boehringer Ingelheim Investigational Site
Salzgitter
1199.15.49055 Boehringer Ingelheim Investigational Site
Solingen
1199.15.49092 Boehringer Ingelheim Investigational Site
Stadthagen
1199.15.49063 Boehringer Ingelheim Investigational Site
Stendal
1199.15.49093 Boehringer Ingelheim Investigational Site
Stralsund
1199.15.49033 Boehringer Ingelheim Investigational Site
Stuttgart
1199.15.49056 Boehringer Ingelheim Investigational Site
Stuttgart
1199.15.49090 Boehringer Ingelheim Investigational Site
Stuttgart
1199.15.49079 Boehringer Ingelheim Investigational Site
Suhl
1199.15.49034 Boehringer Ingelheim Investigational Site
Traunstein
1199.15.49057 Boehringer Ingelheim Investigational Site
Trier
1199.15.49035 Boehringer Ingelheim Investigational Site
Tübingen
1199.15.49058 Boehringer Ingelheim Investigational Site
Ulm
1199.15.49085 Boehringer Ingelheim Investigational Site
Viersen
1199.15.49001 Boehringer Ingelheim Investigational Site
Wiesbaden
1199.15.49036 Boehringer Ingelheim Investigational Site
Wiesbaden
1199.15.49059 Boehringer Ingelheim Investigational Site
Witten
1199.15.49037 Boehringer Ingelheim Investigational Site
Wolfsburg
1199.15.49060 Boehringer Ingelheim Investigational Site
Worms

Other trials in Germany

Italy35 sites

1199.15.39027 Boehringer Ingelheim Investigational Site
Asti
1199.15.39002 Boehringer Ingelheim Investigational Site
Avellino
1199.15.39003 Boehringer Ingelheim Investigational Site
Aviano (PN)
1199.15.39004 Boehringer Ingelheim Investigational Site
Bari
1199.15.39005 Boehringer Ingelheim Investigational Site
Benevento
1199.15.39029 Boehringer Ingelheim Investigational Site
Brescia
1199.15.39040 Boehringer Ingelheim Investigational Site
Catania
1199.15.39007 Boehringer Ingelheim Investigational Site
Catanzaro
1199.15.39008 Boehringer Ingelheim Investigational Site
Faenza (RA)
1199.15.39039 Boehringer Ingelheim Investigational Site
Ferrara
1199.15.39017 Boehringer Ingelheim Investigational Site
Genova
1199.15.39037 Boehringer Ingelheim Investigational Site
Lecce
1199.15.39009 Boehringer Ingelheim Investigational Site
Mantua
1199.15.39033 Boehringer Ingelheim Investigational Site
Meldola (FC)
1199.15.39021 Boehringer Ingelheim Investigational Site
Milan
1199.15.39028 Boehringer Ingelheim Investigational Site
Milan
1199.15.39036 Boehringer Ingelheim Investigational Site
Milan
1199.15.39010 Boehringer Ingelheim Investigational Site
Modena
1199.15.39026 Boehringer Ingelheim Investigational Site
Monza
1199.15.39001 Boehringer Ingelheim Investigational Site
Naples
1199.15.39022 Boehringer Ingelheim Investigational Site
Padova
1199.15.39011 Boehringer Ingelheim Investigational Site
Palermo
1199.15.39031 Boehringer Ingelheim Investigational Site
Palermo
1199.15.39023 Boehringer Ingelheim Investigational Site
Pisa
1199.15.39012 Boehringer Ingelheim Investigational Site
Pordenone
1199.15.39024 Boehringer Ingelheim Investigational Site
Reggio Emilia
1199.15.39013 Boehringer Ingelheim Investigational Site
Roma
1199.15.39014 Boehringer Ingelheim Investigational Site
Roma
1199.15.39034 Boehringer Ingelheim Investigational Site
Rozzano (MI)
1199.15.39030 Boehringer Ingelheim Investigational Site
San Fermo della Battaglia
1199.15.39018 Boehringer Ingelheim Investigational Site
Sondrio
1199.15.39006 Boehringer Ingelheim Investigational Site
Tappino (CB)
1199.15.39019 Boehringer Ingelheim Investigational Site
Torino
1199.15.39020 Boehringer Ingelheim Investigational Site
Torino
1199.15.39032 Boehringer Ingelheim Investigational Site
Varese

Other trials in Italy

United States33 sites

1199.15.10013 Boehringer Ingelheim Investigational Site
Abington, Pennsylvania
1199.15.10016 Boehringer Ingelheim Investigational Site
Allentown, Pennsylvania
1199.15.10010 Boehringer Ingelheim Investigational Site
Augusta, Georgia
1199.15.10104 Boehringer Ingelheim Investigational Site
Austin, Texas
1199.15.10100 Boehringer Ingelheim Investigational Site
Bedford, Texas
1199.15.10019 Boehringer Ingelheim Investigational Site
Bismarck, North Dakota
1199.15.10024 Boehringer Ingelheim Investigational Site
Canton, Ohio
1199.15.10012 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1199.15.10006 Boehringer Ingelheim Investigational Site
Chattanooga, Tennessee
1199.15.10025 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
1199.15.10029 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
1199.15.10107 Boehringer Ingelheim Investigational Site
Dallas, Texas
1199.15.10108 Boehringer Ingelheim Investigational Site
Dallas, Texas
1199.15.10017 Boehringer Ingelheim Investigational Site
Detroit, Michigan
1199.15.10005 Boehringer Ingelheim Investigational Site
Englewood, Colorado
1199.15.10110 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
1199.15.10102 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1199.15.10007 Boehringer Ingelheim Investigational Site
Houston, Texas
1199.15.10030 Boehringer Ingelheim Investigational Site
Long Beach, California
1199.15.10011 Boehringer Ingelheim Investigational Site
Louisville, Kentucky
1199.15.10003 Boehringer Ingelheim Investigational Site
Marrero, Louisiana
1199.15.10103 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota
1199.15.10028 Boehringer Ingelheim Investigational Site
New Haven, Connecticut
1199.15.10002 Boehringer Ingelheim Investigational Site
New York, New York
1199.15.10014 Boehringer Ingelheim Investigational Site
Orlando, Florida
1199.15.10021 Boehringer Ingelheim Investigational Site
Portland, Oregon
1199.15.10008 Boehringer Ingelheim Investigational Site
Providence, Rhode Island
1199.15.10001 Boehringer Ingelheim Investigational Site
Santa Rosa, California
1199.15.10004 Boehringer Ingelheim Investigational Site
Savannah, Georgia
1199.15.10105 Boehringer Ingelheim Investigational Site
Spokane, Washington
1199.15.10113 Boehringer Ingelheim Investigational Site
Tucson, Arizona
1199.15.10112 Boehringer Ingelheim Investigational Site
Vancouver, Washington
1199.15.10020 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

France31 sites

1199.15.33047 Boehringer Ingelheim Investigational Site
Aix-en-Provence
1199.15.33035 Boehringer Ingelheim Investigational Site
Avignon
1199.15.33055 Boehringer Ingelheim Investigational Site
Besançon
1199.15.33003 Boehringer Ingelheim Investigational Site
Bordeaux
1199.15.33004 Boehringer Ingelheim Investigational Site
Bordeaux
1199.15.33006 Boehringer Ingelheim Investigational Site
Caen
1199.15.33025 Boehringer Ingelheim Investigational Site
Clermont-Ferrand
1199.15.33048 Boehringer Ingelheim Investigational Site
Dechy
1199.15.33042 Boehringer Ingelheim Investigational Site
Fréjus
1199.15.33037 Boehringer Ingelheim Investigational Site
La Roche-sur-Yon
1199.15.33008 Boehringer Ingelheim Investigational Site
Le Mans
1199.15.33009 Boehringer Ingelheim Investigational Site
Lille
1199.15.33020 Boehringer Ingelheim Investigational Site
Lyon
1199.15.33011 Boehringer Ingelheim Investigational Site
Marseille
1199.15.33021 Boehringer Ingelheim Investigational Site
Monaco Cedex
1199.15.33012 Boehringer Ingelheim Investigational Site
Mont-de-Marsan
1199.15.33052 Boehringer Ingelheim Investigational Site
Montpellier
1199.15.33053 Boehringer Ingelheim Investigational Site
Mougins
1199.15.33038 Boehringer Ingelheim Investigational Site
Nancy
1199.15.33013 Boehringer Ingelheim Investigational Site
Nantes
1199.15.33015 Boehringer Ingelheim Investigational Site
Orléans
1199.15.33001 Boehringer Ingelheim Investigational Site
Paris
1199.15.33027 Boehringer Ingelheim Investigational Site
Paris
1199.15.33051 Boehringer Ingelheim Investigational Site
Périgueux
1199.15.33030 Boehringer Ingelheim Investigational Site
Plerin SUR MER
1199.15.33045 Boehringer Ingelheim Investigational Site
Saint-Cloud
1199.15.33033 Boehringer Ingelheim Investigational Site
Saint-Herblain
1199.15.33018 Boehringer Ingelheim Investigational Site
Strasbourg
1199.15.33039 Boehringer Ingelheim Investigational Site
Thonon-les-Bains
1199.15.33031 Boehringer Ingelheim Investigational Site
Vandœuvre-lès-Nancy
1199.15.33050 Boehringer Ingelheim Investigational Site
Villejuif

Other trials in France

Austria9 sites

1199.15.43003 Boehringer Ingelheim Investigational Site
Graz
1199.15.43001 Boehringer Ingelheim Investigational Site
Innsbruck
1199.15.43011 Boehringer Ingelheim Investigational Site
Krems
1199.15.43007 Boehringer Ingelheim Investigational Site
Kufstein
1199.15.43005 Boehringer Ingelheim Investigational Site
Linz
1199.15.43010 Boehringer Ingelheim Investigational Site
Salzburg
1199.15.43002 Boehringer Ingelheim Investigational Site
Vienna
1199.15.43012 Boehringer Ingelheim Investigational Site
Vienna
1199.15.43013 Boehringer Ingelheim Investigational Site
Wels

Other trials in Austria

Spain8 sites

1199.15.34001 Boehringer Ingelheim Investigational Site
Badalona
1199.15.34003 Boehringer Ingelheim Investigational Site
Barcelona
1199.15.34006 Boehringer Ingelheim Investigational Site
Girona
1199.15.34004 Boehringer Ingelheim Investigational Site
Lleida
1199.15.34002 Boehringer Ingelheim Investigational Site
Madrid
1199.15.34010 Boehringer Ingelheim Investigational Site
Madrid
1199.15.34005 Boehringer Ingelheim Investigational Site
Palma de Mallorca
1199.15.34009 Boehringer Ingelheim Investigational Site
Valencia

Other trials in Spain

United Kingdom8 sites

1199.15.44006 Boehringer Ingelheim Investigational Site
Derby
1199.15.44007 Boehringer Ingelheim Investigational Site
Dundee
1199.15.44003 Boehringer Ingelheim Investigational Site
Glasgow
1199.15.44001 Boehringer Ingelheim Investigational Site
Guildford
1199.15.44005 Boehringer Ingelheim Investigational Site
London
1199.15.44004 Boehringer Ingelheim Investigational Site
Nottingham
1199.15.44002 Boehringer Ingelheim Investigational Site
Poole
1199.15.44008 Boehringer Ingelheim Investigational Site
Truro

Other trials in United Kingdom

Australia7 sites

1199.15.61006 Boehringer Ingelheim Investigational Site
Camperdown, New South Wales
1199.15.61004 Boehringer Ingelheim Investigational Site
Herston, Queensland
1199.15.61002 Boehringer Ingelheim Investigational Site
Nedlands, Western Australia
1199.15.61005 Boehringer Ingelheim Investigational Site
North Terrace, South Australia
1199.15.61007 Boehringer Ingelheim Investigational Site
Parkville, Victoria
1199.15.61003 Boehringer Ingelheim Investigational Site
Southe Brisbane, Queensland
1199.15.61001 Boehringer Ingelheim Investigational Site
Waratah, New South Wales

Other trials in Australia

Canada7 sites

1199.15.11004 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1199.15.11008 Boehringer Ingelheim Investigational Site
London, Ontario
1199.15.11003 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1199.15.11006 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1199.15.11001 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec
1199.15.11009 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1199.15.11005 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

Other trials in Canada

Portugal7 sites

1199.15.35102 Boehringer Ingelheim Investigational Site
Coimbra
1199.15.35104 Boehringer Ingelheim Investigational Site
Coimbra
1199.15.35101 Instituto Portugues de Oncologia Lisboa Francisco Gentil
Lisbon
1199.15.35106 Boehringer Ingelheim Investigational Site
Lisbon
1199.15.35108 Boehringer Ingelheim Investigational Site
Lisbon
1199.15.35105 Boehringer Ingelheim Investigational Site
Porto
1199.15.35109 Boehringer Ingelheim Investigational Site
Vila Real

Other trials in Portugal

Belgium6 sites

1199.15.32010 Boehringer Ingelheim Investigational Site
Edegem
1199.15.32012 Boehringer Ingelheim Investigational Site
Hasselt
1199.15.32003 Boehringer Ingelheim Investigational Site
La Louvière
1199.15.32001 Boehringer Ingelheim Investigational Site
Leuven
1199.15.32007 Boehringer Ingelheim Investigational Site
Liège
1199.15.32008 Boehringer Ingelheim Investigational Site
Sint-Niklaas

Other trials in Belgium

Netherlands6 sites

1199.15.31009 Boehringer Ingelheim Investigational Site
's-Hertogenbosch
1199.15.31005 Boehringer Ingelheim Investigational Site
Amersfoort
1199.15.31004 Boehringer Ingelheim Investigational Site
Niewegein
1199.15.31003 Boehringer Ingelheim Investigational Site
Nijmegen
1199.15.31006 Boehringer Ingelheim Investigational Site
Rotterdam
1199.15.31002 Boehringer Ingelheim Investigational Site
Utrecht

Other trials in Netherlands

Slovakia6 sites

1199.15.42101 Boehringer Ingelheim Investigational Site
Bratislava
1199.15.42105 Boehringer Ingelheim Investigational Site
Bratislava
1199.15.42106 Boehringer Ingelheim Investigational Site
Košice
1199.15.42103 Boehringer Ingelheim Investigational Site
Nitra
1199.15.42104 Boehringer Ingelheim Investigational Site
Poprad
1199.15.42102 Boehringer Ingelheim Investigational Site
Žilina

Other trials in Slovakia

Denmark5 sites

1199.15.45004 Boehringer Ingelheim Investigational Site
Aalborg
1199.15.45002 Boehringer Ingelheim Investigational Site
Herlev
1199.15.45005 Boehringer Ingelheim Investigational Site
Herning
1199.15.45001 Boehringer Ingelheim Investigational Site
Købenahvn Ø
1199.15.45003 Boehringer Ingelheim Investigational Site
Odense C

Other trials in Denmark

Finland5 sites

1199.15.35801 Boehringer Ingelheim Investigational Site
Helsinki
1199.15.35804 Boehringer Ingelheim Investigational Site
Jyväskylä
1199.15.35805 Boehringer Ingelheim Investigational Site
Kuopio
1199.15.35803 Boehringer Ingelheim Investigational Site
Oulu
1199.15.35802 Boehringer Ingelheim Investigational Site
Tampere

Other trials in Finland

Greece5 sites

1199.15.30001 Boehringer Ingelheim Investigational Site
Athens
1199.15.30003 Boehringer Ingelheim Investigational Site
Heraklio
1199.15.30002 Boehringer Ingelheim Investigational Site
Nea Kifissia
1199.15.30005 Boehringer Ingelheim Investigational Site
Pátrai
1199.15.30004 Boehringer Ingelheim Investigational Site
Thessaloniki

Other trials in Greece

Russia5 sites

1199.15.70006 Boehringer Ingelheim Investigational Site
Barnaul
1199.15.70007 Boehringer Ingelheim Investigational Site
Kazan'
1199.15.70001 Boehringer Ingelheim Investigational Site
Moscow
1199.15.70002 Boehringer Ingelheim Investigational Site
Saint Petersburg
1199.15.70005 Boehringer Ingelheim Investigational Site
Yekaterinburg

Other trials in Russia

Sweden5 sites

1199.15.46005 Boehringer Ingelheim Investigational Site
Linköping
1199.15.46001 Boehringer Ingelheim Investigational Site
Lund
1199.15.46002 Boehringer Ingelheim Investigational Site
Stockholm
1199.15.46004 Boehringer Ingelheim Investigational Site
Umeå
1199.15.46003 Boehringer Ingelheim Investigational Site
Uppsala

Other trials in Sweden

Ukraine5 sites

1199.15.38006 Boehringer Ingelheim Investigational Site
Cherkasy
1199.15.38005 Boehringer Ingelheim Investigational Site
Dnipro
1199.15.38004 Boehringer Ingelheim Investigational Site
Donetsk
1199.15.38002 Boehringer Ingelheim Investigational Site
Kharkiv
1199.15.38003 Boehringer Ingelheim Investigational Site
Lviv

Other trials in Ukraine

Norway4 sites

1199.15.47003 Boehringer Ingelheim Investigational Site
Bergen
1199.15.47001 Boehringer Ingelheim Investigational Site
Oslo
1199.15.47002 Boehringer Ingelheim Investigational Site
Stavanger
1199.15.47004 Boehringer Ingelheim Investigational Site
Trondheim

Other trials in Norway

Czechia3 sites

1199.15.42002 Boehringer Ingelheim Investigational Site
Brno
1199.15.42003 Boehringer Ingelheim Investigational Site
Olomouc
1199.15.42001 Boehringer Ingelheim Investigational Site
Prague

Other trials in Czechia

Poland3 sites

1199.15.48003 Boehringer Ingelheim Investigational Site
Gdansk
1199.15.48006 Boehringer Ingelheim Investigational Site
Lublin
1199.15.48001 Boehringer Ingelheim Investigational Site
Warsaw

Other trials in Poland

About this study

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

Conditions: Ovarian Neoplasms, Peritoneal Neoplasms
Being tested: Placebo, Paclitaxel, BIBF 1120, Carboplatin
Medical subject headings: Ovarian Neoplasms, Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01015118
Study group	Role	What they receive
BIBF 1120	Experimental	patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel Receives: Drug: BIBF 1120; Drug: Paclitaxel; Drug: Carboplatin
Placebo	Placebo comparator	patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel Receives: Drug: Placebo; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: First drug administration to date of disease progression or death whichever occurs first , upto 29 months
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.
Measured: First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months

Secondary outcomes (7)

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.
Measured: First drug administration to date of disease progression or death whichever occurs first , upto 29 months
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.
Measured: First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months
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.
Measured: First drug administration to date of death until final DBL 26September16, upto 62 months
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.
Measured: First drug administration until final DBL 26September16, upto 62 months
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
Measured: First drug administration until final DBL 26September16, upto 62 months
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).
Measured: First drug administration until final DBL 26September16, upto 62 months
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).
Measured: First drug administration until final DBL 26September16, upto 62 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 200915 Sep 2016

First posted18 Nov 2009 (estimated)
Study start17 Nov 2009
Primary completion1 Apr 2013
Study completion15 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,366 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01015118
Sponsor's protocol ID: 1199.15
Other IDs: AGO-OVAR12, 2008-006831-10, 2008
Status last verified: Nov 2017
First submitted: 9 Nov 2009
Last updated: 7 Dec 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PubMed 37185961
du Bois A, Kristensen G, Ray-Coquard I, Reuss A, Pignata S, Colombo N, Denison U, Vergote I, Del Campo JM, Ottevanger P, Heubner M, Minarik T, Sevin E, de Gregorio N, Bidzinski M, Pfisterer J, Malander S, Hilpert F, Mirza MR, Scambia G, Meier W, Nicoletto MO, Bjorge L, Lortholary A, Sailer MO, Merger M, Harter P; AGO Study Group led Gynecologic Cancer Intergroup/European Network of Gynaecologic Oncology Trials Groups Intergroup Consortium. Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2016 Jan;17(1):78-89. doi: 10.1016/S1470-2045(15)00366-6. Epub 2015 Nov 16.
PubMed 26590673

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ovarian Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01015118
Acronym / sponsor ID: 1199.15
Conditions: Ovarian Neoplasms, Peritoneal Neoplasms
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,366 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 17 Nov 2009 (actual)
Primary completion: 1 Apr 2013 (actual)
Study completion: 15 Sep 2016 (actual)
First posted: 18 Nov 2009 (estimated)
Results: Posted 15 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
BIBF 1120	Experimental	Drug: BIBF 1120, Drug: Paclitaxel, Drug: Carboplatinpatients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel
Placebo	Placebo comparator	Drug: Placebo, Drug: Paclitaxel, Drug: Carboplatinpatients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (28 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebocomparator to BIBF 1120	Drug	Placebo
PaclitaxelPaclitaxel (standard chemo-therapy)	Drug	Placebo
BIBF 1120comparison of BIBF 1120 in combination with chemotherapy and placebo in combination with chemotherapy (paclitaxel/carboplatin)	Drug	BIBF 1120
CarboplatinCarboplatin (standard chemo-therapy)	Drug	Placebo
PaclitaxelPaclitaxel (standard chemo-therapy)	Drug	BIBF 1120
CarboplatinCarboplatin (standard chemo-therapy)	Drug	BIBF 1120

Primary outcome

PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.
Time frame: First drug administration to date of disease progression or death whichever occurs first , upto 29 months
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.
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).
Time frame: First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months
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.

7 secondary outcomes

PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint).
Time frame: First drug administration to date of disease progression or death whichever occurs first , upto 29 months
PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis).
Time frame: First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months
Overall Survival
Time frame: First drug administration to date of death until final DBL 26September16, upto 62 months
Time to CA-125 Tumour Marker Progression
Time frame: First drug administration until final DBL 26September16, upto 62 months
Objective Response Based on Investigator Assessment
Time frame: First drug administration until final DBL 26September16, upto 62 months
Change in Abdominal/Gastro-intestinal Symptoms Over Time
Time frame: First drug administration until final DBL 26September16, upto 62 months
Change in Global Health Status/ Quality of Life (QoL) Scale Over Time.
Time frame: First drug administration until final DBL 26September16, upto 62 months

Results and safety

Results posted to the registry on 15 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nintedanib	911	242
Placebo	455	128

Primary outcome: PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.

Time frame: First drug administration to date of disease progression or death whichever occurs first , upto 29 months. Median (Inter-Quartile Range). Unit: Months

Measure	Nintedanib n = 911	Placebo n = 455
Value	17.2 (11.1 to 32.5)	16.6 (10.8 to 30.4)

Nintedanib vs Placebo: Hazard Ratio (HR): 0.84 (95% CI 0.72 to 0.98), p = 0.0239, Log Rank

Population analysed: Randomised Set (RS)

Primary outcome: 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).

Time frame: First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months. Median (Inter-Quartile Range). Unit: Months

Measure	Nintedanib n = 911	Placebo n = 455
Value	17.6 (11.1 to 38.0)	16.6 (10.8 to 37.3)

Nintedanib vs Placebo: Hazard Ratio (HR): 0.86 (95% CI 0.75 to 0.98), p = 0.0286, Log Rank

Population analysed: Randomised Set (RS)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: First drug administration until data cut-off 26September16, up to 62 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	157 of 450 (34.9%)	442 of 450 (98.2%)	Not reported
Nintedanib	379 of 902 (42%)	891 of 902 (98.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37185961Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
Derived from this study: PubMed 26590673du Bois A, Kristensen G, Ray-Coquard I, Reuss A, Pignata S, Colombo N, Denison U, Vergote I, Del Campo JM, Ottevanger P, Heubner M, Minarik T, Sevin E, de Gregorio N, Bidzinski M, Pfisterer J, Malander S, Hilpert F, Mirza MR, Scambia G, Meier W, Nicoletto MO, Bjorge L, Lortholary A, Sailer MO, Merger M, Harter P; AGO Study Group led Gynecologic Cancer Intergroup/European Network of Gynaecologic Oncology Trials Groups Intergroup Consortium. Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2016 Jan;17(1):78-89. doi: 10.1016/S1470-2045(15)00366-6. Epub 2015 Nov 16.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

281 sites in 22 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclitaxel, BIBF 1120 and Carboplatin in people with Ovarian Neoplasms and Peritoneal Neoplasms, run by Boehringer Ingelheim at 281 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 281 sites in Germany, Italy, United States, France, Austria and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. (time frame: First drug administration to date of disease progression or death whichever occurs first , upto 29 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01015118, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.