Clinical trial NCT01015118: LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Neoplasms
Peritoneal Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-11-18
Enrollment: 1366
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.
timeFrame: First drug administration to date of disease progression or death whichever occurs first , upto 29 months
measure: 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).
timeFrame: 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:
measure: PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint).
timeFrame: First drug administration to date of disease progression or death whichever occurs first , upto 29 months
measure: PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis).
timeFrame: First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months
measure: Overall Survival
timeFrame: First drug administration to date of death until final DBL 26September16, upto 62 months
measure: Time to CA-125 Tumour Marker Progression
timeFrame: First drug administration until final DBL 26September16, upto 62 months
measure: Objective Response Based on Investigator Assessment
timeFrame: First drug administration until final DBL 26September16, upto 62 months
measure: Change in Abdominal/Gastro-intestinal Symptoms Over Time
timeFrame: First drug administration until final DBL 26September16, upto 62 months
measure: Change in Global Health Status/ Quality of Life (QoL) Scale Over Time.
timeFrame: First drug administration until final DBL 26September16, upto 62 months
Other outcomes:
Locations:
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country: United States
facility: 1199.15.10113 Boehringer Ingelheim Investigational Site
state: Arizona
city: Long Beach
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facility: 1199.15.10030 Boehringer Ingelheim Investigational Site
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city: Santa Rosa
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facility: 1199.15.10001 Boehringer Ingelheim Investigational Site
state: California
city: Englewood
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facility: 1199.15.10005 Boehringer Ingelheim Investigational Site
state: Colorado
city: New Haven
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facility: 1199.15.10028 Boehringer Ingelheim Investigational Site
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facility: 1199.15.10014 Boehringer Ingelheim Investigational Site
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facility: 1199.15.10010 Boehringer Ingelheim Investigational Site
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city: Savannah
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facility: 1199.15.10004 Boehringer Ingelheim Investigational Site
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city: Louisville
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facility: 1199.15.10003 Boehringer Ingelheim Investigational Site
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facility: 1199.15.10017 Boehringer Ingelheim Investigational Site
state: Michigan
city: Minneapolis
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facility: 1199.15.10103 Boehringer Ingelheim Investigational Site
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city: New York
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facility: 1199.15.10002 Boehringer Ingelheim Investigational Site
state: New York
city: Charlotte
country: United States
facility: 1199.15.10012 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 1199.15.10020 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: 1199.15.10019 Boehringer Ingelheim Investigational Site
state: North Dakota
city: Canton
country: United States
facility: 1199.15.10024 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: 1199.15.10025 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: 1199.15.10029 Boehringer Ingelheim Investigational Site
state: Ohio
city: Portland
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facility: 1199.15.10021 Boehringer Ingelheim Investigational Site
state: Oregon
city: Abington
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facility: 1199.15.10013 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Allentown
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facility: 1199.15.10016 Boehringer Ingelheim Investigational Site
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city: Providence
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facility: 1199.15.10008 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Greenville
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facility: 1199.15.10102 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: 1199.15.10006 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Austin
country: United States
facility: 1199.15.10104 Boehringer Ingelheim Investigational Site
state: Texas
city: Bedford
country: United States
facility: 1199.15.10100 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1199.15.10107 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1199.15.10108 Boehringer Ingelheim Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: 1199.15.10110 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1199.15.10007 Boehringer Ingelheim Investigational Site
state: Texas
city: Spokane
country: United States
facility: 1199.15.10105 Boehringer Ingelheim Investigational Site
state: Washington
city: Vancouver
country: United States
facility: 1199.15.10112 Boehringer Ingelheim Investigational Site
state: Washington
city: Camperdown
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facility: 1199.15.61006 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Waratah
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facility: 1199.15.61001 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: 1199.15.61004 Boehringer Ingelheim Investigational Site
state: Queensland
city: Southe Brisbane
country: Australia
facility: 1199.15.61003 Boehringer Ingelheim Investigational Site
state: Queensland
city: North Terrace
country: Australia
facility: 1199.15.61005 Boehringer Ingelheim Investigational Site
state: South Australia
city: Parkville
country: Australia
facility: 1199.15.61007 Boehringer Ingelheim Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: 1199.15.61002 Boehringer Ingelheim Investigational Site
state: Western Australia
city: Graz
country: Austria
facility: 1199.15.43003 Boehringer Ingelheim Investigational Site
city: Innsbruck
country: Austria
facility: 1199.15.43001 Boehringer Ingelheim Investigational Site
city: Krems
country: Austria
facility: 1199.15.43011 Boehringer Ingelheim Investigational Site
city: Kufstein
country: Austria
facility: 1199.15.43007 Boehringer Ingelheim Investigational Site
city: Linz
country: Austria
facility: 1199.15.43005 Boehringer Ingelheim Investigational Site
city: Salzburg
country: Austria
facility: 1199.15.43010 Boehringer Ingelheim Investigational Site
city: Wels
country: Austria
facility: 1199.15.43013 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1199.15.43002 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1199.15.43012 Boehringer Ingelheim Investigational Site
city: Edegem
country: Belgium
facility: 1199.15.32010 Boehringer Ingelheim Investigational Site
city: Hasselt
country: Belgium
facility: 1199.15.32012 Boehringer Ingelheim Investigational Site
city: La Louvière
country: Belgium
facility: 1199.15.32003 Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: 1199.15.32001 Boehringer Ingelheim Investigational Site
city: Liège
country: Belgium
facility: 1199.15.32007 Boehringer Ingelheim Investigational Site
city: Sint-Niklaas
country: Belgium
facility: 1199.15.32008 Boehringer Ingelheim Investigational Site
city: Vancouver
country: Canada
facility: 1199.15.11005 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Hamilton
country: Canada
facility: 1199.15.11004 Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: 1199.15.11008 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1199.15.11009 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 1199.15.11003 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1199.15.11006 Boehringer Ingelheim Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: 1199.15.11001 Boehringer Ingelheim Investigational Site
state: Quebec
city: Brno
country: Czechia
facility: 1199.15.42002 Boehringer Ingelheim Investigational Site
city: Olomouc
country: Czechia
facility: 1199.15.42003 Boehringer Ingelheim Investigational Site
city: Prague
country: Czechia
facility: 1199.15.42001 Boehringer Ingelheim Investigational Site
city: Aalborg
country: Denmark
facility: 1199.15.45004 Boehringer Ingelheim Investigational Site
city: Herlev
country: Denmark
facility: 1199.15.45002 Boehringer Ingelheim Investigational Site
city: Herning
country: Denmark
facility: 1199.15.45005 Boehringer Ingelheim Investigational Site
city: Købenahvn Ø
country: Denmark
facility: 1199.15.45001 Boehringer Ingelheim Investigational Site
city: Odense C
country: Denmark
facility: 1199.15.45003 Boehringer Ingelheim Investigational Site
city: Helsinki
country: Finland
facility: 1199.15.35801 Boehringer Ingelheim Investigational Site
city: Jyväskylä
country: Finland
facility: 1199.15.35804 Boehringer Ingelheim Investigational Site
city: Kuopio
country: Finland
facility: 1199.15.35805 Boehringer Ingelheim Investigational Site
city: Oulu
country: Finland
facility: 1199.15.35803 Boehringer Ingelheim Investigational Site
city: Tampere
country: Finland
facility: 1199.15.35802 Boehringer Ingelheim Investigational Site
city: Aix-en-Provence
country: France
facility: 1199.15.33047 Boehringer Ingelheim Investigational Site
city: Avignon cedex 02
country: France
facility: 1199.15.33035 Boehringer Ingelheim Investigational Site
city: Besançon
country: France
facility: 1199.15.33055 Boehringer Ingelheim Investigational Site
city: Bordeaux cedex
country: France
facility: 1199.15.33003 Boehringer Ingelheim Investigational Site
city: Bordeaux
country: France
facility: 1199.15.33004 Boehringer Ingelheim Investigational Site
city: Caen cedex 5
country: France
facility: 1199.15.33006 Boehringer Ingelheim Investigational Site
city: Clermont-Ferrand cedex
country: France
facility: 1199.15.33025 Boehringer Ingelheim Investigational Site
city: Dechy
country: France
facility: 1199.15.33048 Boehringer Ingelheim Investigational Site
city: Fréjus
country: France
facility: 1199.15.33042 Boehringer Ingelheim Investigational Site
city: La Roche-Sur-Yon cedex 09
country: France
facility: 1199.15.33037 Boehringer Ingelheim Investigational Site
city: Le Mans
country: France
facility: 1199.15.33008 Boehringer Ingelheim Investigational Site
city: Lille cedex
country: France
facility: 1199.15.33009 Boehringer Ingelheim Investigational Site
city: Lyon
country: France
facility: 1199.15.33020 Boehringer Ingelheim Investigational Site
city: Marseille cedex 09
country: France
facility: 1199.15.33011 Boehringer Ingelheim Investigational Site
city: Monaco Cedex
country: France
facility: 1199.15.33021 Boehringer Ingelheim Investigational Site
city: Mont-de-Marsan cedex
country: France
facility: 1199.15.33012 Boehringer Ingelheim Investigational Site
city: Montpellier cedex 5
country: France
facility: 1199.15.33052 Boehringer Ingelheim Investigational Site
city: Mougins
country: France
facility: 1199.15.33053 Boehringer Ingelheim Investigational Site
city: Nancy
country: France
facility: 1199.15.33038 Boehringer Ingelheim Investigational Site
city: Nantes cedex 02
country: France
facility: 1199.15.33013 Boehringer Ingelheim Investigational Site
city: Orléans cedex 02
country: France
facility: 1199.15.33015 Boehringer Ingelheim Investigational Site
city: Paris cedex 20
country: France
facility: 1199.15.33027 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1199.15.33001 Boehringer Ingelheim Investigational Site
city: PERIGUEUX Cedex
country: France
facility: 1199.15.33051 Boehringer Ingelheim Investigational Site
city: Plerin SUR MER
country: France
facility: 1199.15.33030 Boehringer Ingelheim Investigational Site
city: Saint Cloud
country: France
facility: 1199.15.33045 Boehringer Ingelheim Investigational Site
city: Saint-Herblain cedex
country: France
facility: 1199.15.33033 Boehringer Ingelheim Investigational Site
city: Strasbourg cedex
country: France
facility: 1199.15.33018 Boehringer Ingelheim Investigational Site
city: Thonon-Les-Bains
country: France
facility: 1199.15.33039 Boehringer Ingelheim Investigational Site
city: Vandoeuvre les Nancy cedex
country: France
facility: 1199.15.33031 Boehringer Ingelheim Investigational Site
city: Villejuif Cedex
country: France
facility: 1199.15.33050 Boehringer Ingelheim Investigational Site
city: Aachen
country: Germany
facility: 1199.15.49040 Boehringer Ingelheim Investigational Site
city: Aalen
country: Germany
facility: 1199.15.49070 Boehringer Ingelheim Investigational Site
city: Aschaffenburg
country: Germany
facility: 1199.15.49086 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1199.15.49002 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1199.15.49039 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1199.15.49041 Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: 1199.15.49004 Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: 1199.15.49042 Boehringer Ingelheim Investigational Site
city: Bottrop
country: Germany
facility: 1199.15.49071 Boehringer Ingelheim Investigational Site
city: Böblingen
country: Germany
facility: 1199.15.49081 Boehringer Ingelheim Investigational Site
city: Chemnitz
country: Germany
facility: 1199.15.49043 Boehringer Ingelheim Investigational Site
city: Dessau
country: Germany
facility: 1199.15.49005 Boehringer Ingelheim Investigational Site
city: Detmold
country: Germany
facility: 1199.15.49006 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1199.15.49007 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1199.15.49067 Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: 1199.15.49008 Boehringer Ingelheim Investigational Site
city: Ebersberg
country: Germany
facility: 1199.15.49009 Boehringer Ingelheim Investigational Site
city: Essen
country: Germany
facility: 1199.15.49010 Boehringer Ingelheim Investigational Site
city: Essen
country: Germany
facility: 1199.15.49066 Boehringer Ingelheim Investigational Site
city: Essen
country: Germany
facility: 1199.15.49089 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 1199.15.49045 Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: 1199.15.49011 Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: 1199.15.49068 Boehringer Ingelheim Investigational Site
city: Freudenstadt
country: Germany
facility: 1199.15.49083 Boehringer Ingelheim Investigational Site
city: Fulda
country: Germany
facility: 1199.15.49046 Boehringer Ingelheim Investigational Site
city: Fürstenfeldbruck
country: Germany
facility: 1199.15.49012 Boehringer Ingelheim Investigational Site
city: Greifswald
country: Germany
facility: 1199.15.49064 Boehringer Ingelheim Investigational Site
city: Gütersloh
country: Germany
facility: 1199.15.49076 Boehringer Ingelheim Investigational Site
city: Halle/S.
country: Germany
facility: 1199.15.49014 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1199.15.49015 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1199.15.49084 Boehringer Ingelheim Investigational Site
city: Hanau
country: Germany
facility: 1199.15.49073 Boehringer Ingelheim Investigational Site
city: Heidelberg
country: Germany
facility: 1199.15.49095 Boehringer Ingelheim Investigational Site
city: Henstedt-Ulzburg
country: Germany
facility: 1199.15.49080 Boehringer Ingelheim Investigational Site
city: Hildesheim
country: Germany
facility: 1199.15.49047 Boehringer Ingelheim Investigational Site
city: Karlsruhe
country: Germany
facility: 1199.15.49016 Boehringer Ingelheim Investigational Site
city: Kiel
country: Germany
facility: 1199.15.49017 Boehringer Ingelheim Investigational Site
city: Krefeld
country: Germany
facility: 1199.15.49062 Boehringer Ingelheim Investigational Site
city: Landshut
country: Germany
facility: 1199.15.49018 Boehringer Ingelheim Investigational Site
city: Ludwigsburg
country: Germany
facility: 1199.15.49087 Boehringer Ingelheim Investigational Site
city: Lübeck
country: Germany
facility: 1199.15.49019 Boehringer Ingelheim Investigational Site
city: Magdeburg
country: Germany
facility: 1199.15.49020 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1199.15.49021 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1199.15.49022 Boehringer Ingelheim Investigational Site
city: Mannheim
country: Germany
facility: 1199.15.49023 Boehringer Ingelheim Investigational Site
city: Marburg
country: Germany
facility: 1199.15.49024 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1199.15.49025 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1199.15.49026 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1199.15.49027 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1199.15.49048 Boehringer Ingelheim Investigational Site
city: Neumarkt i.d.Opf.
country: Germany
facility: 1199.15.49065 Boehringer Ingelheim Investigational Site
city: Offenbach
country: Germany
facility: 1199.15.49029 Boehringer Ingelheim Investigational Site
city: Paderborn
country: Germany
facility: 1199.15.49082 Boehringer Ingelheim Investigational Site
city: Radebeul
country: Germany
facility: 1199.15.49030 Boehringer Ingelheim Investigational Site
city: Ravensburg
country: Germany
facility: 1199.15.49061 Boehringer Ingelheim Investigational Site
city: Regensburg
country: Germany
facility: 1199.15.49050 Boehringer Ingelheim Investigational Site
city: Rosenheim
country: Germany
facility: 1199.15.49051 Boehringer Ingelheim Investigational Site
city: Rostock
country: Germany
facility: 1199.15.49052 Boehringer Ingelheim Investigational Site
city: Saalfeld
country: Germany
facility: 1199.15.49054 Boehringer Ingelheim Investigational Site
city: Salzgitter
country: Germany
facility: 1199.15.49031 Boehringer Ingelheim Investigational Site
city: Solingen
country: Germany
facility: 1199.15.49055 Boehringer Ingelheim Investigational Site
city: Stadthagen
country: Germany
facility: 1199.15.49092 Boehringer Ingelheim Investigational Site
city: Stendal
country: Germany
facility: 1199.15.49063 Boehringer Ingelheim Investigational Site
city: Stralsund
country: Germany
facility: 1199.15.49093 Boehringer Ingelheim Investigational Site
city: Stuttgart
country: Germany
facility: 1199.15.49033 Boehringer Ingelheim Investigational Site
city: Stuttgart
country: Germany
facility: 1199.15.49056 Boehringer Ingelheim Investigational Site
city: Stuttgart
country: Germany
facility: 1199.15.49090 Boehringer Ingelheim Investigational Site
city: Suhl
country: Germany
facility: 1199.15.49079 Boehringer Ingelheim Investigational Site
city: Traunstein
country: Germany
facility: 1199.15.49034 Boehringer Ingelheim Investigational Site
city: Trier
country: Germany
facility: 1199.15.49057 Boehringer Ingelheim Investigational Site
city: Tübingen
country: Germany
facility: 1199.15.49035 Boehringer Ingelheim Investigational Site
city: Ulm
country: Germany
facility: 1199.15.49058 Boehringer Ingelheim Investigational Site
city: Viersen
country: Germany
facility: 1199.15.49085 Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: 1199.15.49001 Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: 1199.15.49036 Boehringer Ingelheim Investigational Site
city: Witten
country: Germany
facility: 1199.15.49059 Boehringer Ingelheim Investigational Site
city: Wolfsburg
country: Germany
facility: 1199.15.49037 Boehringer Ingelheim Investigational Site
city: Worms
country: Germany
facility: 1199.15.49060 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1199.15.30001 Boehringer Ingelheim Investigational Site
city: Heraklio
country: Greece
facility: 1199.15.30003 Boehringer Ingelheim Investigational Site
city: Nea Kifisia
country: Greece
facility: 1199.15.30002 Boehringer Ingelheim Investigational Site
city: Patras
country: Greece
facility: 1199.15.30005 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1199.15.30004 Boehringer Ingelheim Investigational Site
city: Asti
country: Italy
facility: 1199.15.39027 Boehringer Ingelheim Investigational Site
city: Avellino
country: Italy
facility: 1199.15.39002 Boehringer Ingelheim Investigational Site
city: Aviano (pn)
country: Italy
facility: 1199.15.39003 Boehringer Ingelheim Investigational Site
city: Bari
country: Italy
facility: 1199.15.39004 Boehringer Ingelheim Investigational Site
city: Benevento
country: Italy
facility: 1199.15.39005 Boehringer Ingelheim Investigational Site
city: Brescia
country: Italy
facility: 1199.15.39029 Boehringer Ingelheim Investigational Site
city: Catania
country: Italy
facility: 1199.15.39040 Boehringer Ingelheim Investigational Site
city: Catanzaro
country: Italy
facility: 1199.15.39007 Boehringer Ingelheim Investigational Site
city: Faenza (RA)
country: Italy
facility: 1199.15.39008 Boehringer Ingelheim Investigational Site
city: Ferrara
country: Italy
facility: 1199.15.39039 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 1199.15.39017 Boehringer Ingelheim Investigational Site
city: Lecce
country: Italy
facility: 1199.15.39037 Boehringer Ingelheim Investigational Site
city: Mantova
country: Italy
facility: 1199.15.39009 Boehringer Ingelheim Investigational Site
city: Meldola (fc)
country: Italy
facility: 1199.15.39033 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1199.15.39021 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1199.15.39028 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1199.15.39036 Boehringer Ingelheim Investigational Site
city: Modena
country: Italy
facility: 1199.15.39010 Boehringer Ingelheim Investigational Site
city: Monza
country: Italy
facility: 1199.15.39026 Boehringer Ingelheim Investigational Site
city: Napoli
country: Italy
facility: 1199.15.39001 Boehringer Ingelheim Investigational Site
city: Padova
country: Italy
facility: 1199.15.39022 Boehringer Ingelheim Investigational Site
city: Palermo
country: Italy
facility: 1199.15.39011 Boehringer Ingelheim Investigational Site
city: Palermo
country: Italy
facility: 1199.15.39031 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 1199.15.39023 Boehringer Ingelheim Investigational Site
city: Pordenone
country: Italy
facility: 1199.15.39012 Boehringer Ingelheim Investigational Site
city: Reggio Emilia
country: Italy
facility: 1199.15.39024 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1199.15.39013 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1199.15.39014 Boehringer Ingelheim Investigational Site
city: Rozzano (MI)
country: Italy
facility: 1199.15.39034 Boehringer Ingelheim Investigational Site
city: San Fermo Della Battaglia
country: Italy
facility: 1199.15.39030 Boehringer Ingelheim Investigational Site
city: Sondrio
country: Italy
facility: 1199.15.39018 Boehringer Ingelheim Investigational Site
city: Tappino (CB)
country: Italy
facility: 1199.15.39006 Boehringer Ingelheim Investigational Site
city: Torino
country: Italy
facility: 1199.15.39019 Boehringer Ingelheim Investigational Site
city: Torino
country: Italy
facility: 1199.15.39020 Boehringer Ingelheim Investigational Site
city: Varese
country: Italy
facility: 1199.15.39032 Boehringer Ingelheim Investigational Site
city: 's-HERTOGENBOSCH
country: Netherlands
facility: 1199.15.31009 Boehringer Ingelheim Investigational Site
city: Amersfoort
country: Netherlands
facility: 1199.15.31005 Boehringer Ingelheim Investigational Site
city: Niewegein
country: Netherlands
facility: 1199.15.31004 Boehringer Ingelheim Investigational Site
city: Nijmegen
country: Netherlands
facility: 1199.15.31003 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 1199.15.31006 Boehringer Ingelheim Investigational Site
city: Utrecht
country: Netherlands
facility: 1199.15.31002 Boehringer Ingelheim Investigational Site
city: Bergen
country: Norway
facility: 1199.15.47003 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1199.15.47001 Boehringer Ingelheim Investigational Site
city: Stavanger
country: Norway
facility: 1199.15.47002 Boehringer Ingelheim Investigational Site
city: Trondheim
country: Norway
facility: 1199.15.47004 Boehringer Ingelheim Investigational Site
city: Gdansk
country: Poland
facility: 1199.15.48003 Boehringer Ingelheim Investigational Site
city: Lublin
country: Poland
facility: 1199.15.48006 Boehringer Ingelheim Investigational Site
city: Warszawa
country: Poland
facility: 1199.15.48001 Boehringer Ingelheim Investigational Site
city: Coimbra
country: Portugal
facility: 1199.15.35102 Boehringer Ingelheim Investigational Site
city: Coimbra
country: Portugal
facility: 1199.15.35104 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1199.15.35101 Instituto Portugues de Oncologia Lisboa Francisco Gentil
city: Lisboa
country: Portugal
facility: 1199.15.35106 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1199.15.35108 Boehringer Ingelheim Investigational Site
city: Porto
country: Portugal
facility: 1199.15.35105 Boehringer Ingelheim Investigational Site
city: Vila Real
country: Portugal
facility: 1199.15.35109 Boehringer Ingelheim Investigational Site
city: Barnaul
country: Russian Federation
facility: 1199.15.70006 Boehringer Ingelheim Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: 1199.15.70005 Boehringer Ingelheim Investigational Site
city: Kazan
country: Russian Federation
facility: 1199.15.70007 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1199.15.70001 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1199.15.70002 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1199.15.42101 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1199.15.42105 Boehringer Ingelheim Investigational Site
city: Kosice
country: Slovakia
facility: 1199.15.42106 Boehringer Ingelheim Investigational Site
city: Nitra
country: Slovakia
facility: 1199.15.42103 Boehringer Ingelheim Investigational Site
city: Poprad
country: Slovakia
facility: 1199.15.42104 Boehringer Ingelheim Investigational Site
city: Zilina
country: Slovakia
facility: 1199.15.42102 Boehringer Ingelheim Investigational Site
city: Badalona
country: Spain
facility: 1199.15.34001 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1199.15.34003 Boehringer Ingelheim Investigational Site
city: Girona
country: Spain
facility: 1199.15.34006 Boehringer Ingelheim Investigational Site
city: Lleida
country: Spain
facility: 1199.15.34004 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1199.15.34002 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1199.15.34010 Boehringer Ingelheim Investigational Site
city: Palma de Mallorca
country: Spain
facility: 1199.15.34005 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1199.15.34009 Boehringer Ingelheim Investigational Site
city: Linköping
country: Sweden
facility: 1199.15.46005 Boehringer Ingelheim Investigational Site
city: Lund
country: Sweden
facility: 1199.15.46001 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1199.15.46002 Boehringer Ingelheim Investigational Site
city: Umeå
country: Sweden
facility: 1199.15.46004 Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: 1199.15.46003 Boehringer Ingelheim Investigational Site
city: Cherkasy
country: Ukraine
facility: 1199.15.38006 Boehringer Ingelheim Investigational Site
city: Dnepropetrovsk
country: Ukraine
facility: 1199.15.38005 Boehringer Ingelheim Investigational Site
city: Donetsk
country: Ukraine
facility: 1199.15.38004 Boehringer Ingelheim Investigational Site
city: Kharkiv
country: Ukraine
facility: 1199.15.38002 Boehringer Ingelheim Investigational Site
city: Lviv
country: Ukraine
facility: 1199.15.38003 Boehringer Ingelheim Investigational Site
city: Derby
country: United Kingdom
facility: 1199.15.44006 Boehringer Ingelheim Investigational Site
city: Dundee
country: United Kingdom
facility: 1199.15.44007 Boehringer Ingelheim Investigational Site
city: Glasgow
country: United Kingdom
facility: 1199.15.44003 Boehringer Ingelheim Investigational Site
city: Guildford
country: United Kingdom
facility: 1199.15.44001 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1199.15.44005 Boehringer Ingelheim Investigational Site
city: Nottingham
country: United Kingdom
facility: 1199.15.44004 Boehringer Ingelheim Investigational Site
city: Poole
country: United Kingdom
facility: 1199.15.44002 Boehringer Ingelheim Investigational Site
city: Truro
country: United Kingdom
facility: 1199.15.44008 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.