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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01015118
First received: November 9, 2009
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Ovarian Neoplasms
Peritoneal Neoplasms
Drug: Placebo
Drug: BIBF 1120
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 41 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival according to Response Evaluation Criteria In Solid Tumors 1.1 criteria [ Time Frame: 41 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 41 months ] [ Designated as safety issue: No ]
  • time to tumour marker progression [ Time Frame: 41 months ] [ Designated as safety issue: No ]
  • objective response [ Time Frame: 41 months ] [ Designated as safety issue: No ]
  • incidence and intensity of adverse events [ Time Frame: 41 months ] [ Designated as safety issue: No ]
  • changes in safety laboratory parameters [ Time Frame: 41 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1375
Study Start Date: November 2009
Estimated Study Completion Date: July 2016
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBF 1120
patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel
Drug: BIBF 1120
comparison of BIBF 1120 in combination with chemotherapy and placebo in combination with chemotherapy (paclitaxel/carboplatin)
Placebo Comparator: Placebo
patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel
Drug: Placebo
comparator to BIBF 1120

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015118

  Hide Study Locations
Locations
United States, Arizona
1199.15.10113 Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
United States, California
1199.15.10030 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
1199.15.10001 Boehringer Ingelheim Investigational Site
Santa Rosa, California, United States
United States, Colorado
1199.15.10005 Boehringer Ingelheim Investigational Site
Englewood, Colorado, United States
United States, Connecticut
1199.15.10028 Boehringer Ingelheim Investigational Site
New Haven, Connecticut, United States
United States, Florida
1199.15.10014 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
United States, Georgia
1199.15.10010 Boehringer Ingelheim Investigational Site
Augusta, Georgia, United States
1199.15.10004 Boehringer Ingelheim Investigational Site
Savannah, Georgia, United States
United States, Kentucky
1199.15.10011 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
United States, Louisiana
1199.15.10003 Boehringer Ingelheim Investigational Site
Marrero, Louisiana, United States
United States, Michigan
1199.15.10017 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
United States, Minnesota
1199.15.10103 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
United States, New York
1199.15.10002 Boehringer Ingelheim Investigational Site
New York, New York, United States
United States, North Carolina
1199.15.10012 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
1199.15.10020 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
United States, North Dakota
1199.15.10019 Boehringer Ingelheim Investigational Site
Bismark, North Dakota, United States
United States, Ohio
1199.15.10024 Boehringer Ingelheim Investigational Site
Canton, Ohio, United States
1199.15.10025 Boehringer Ingelheim Investigational Site
Cleveland, Ohio, United States
1199.15.10029 Boehringer Ingelheim Investigational Site
Cleveland, Ohio, United States
United States, Oregon
1199.15.10021 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, Pennsylvania
1199.15.10013 Boehringer Ingelheim Investigational Site
Abington, Pennsylvania, United States
1199.15.10016 Boehringer Ingelheim Investigational Site
Allentown, Pennsylvania, United States
United States, Rhode Island
1199.15.10008 Boehringer Ingelheim Investigational Site
Providence, Rhode Island, United States
United States, South Carolina
1199.15.10102 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
United States, Tennessee
1199.15.10006 Boehringer Ingelheim Investigational Site
Chattanooga, Tennessee, United States
United States, Texas
1199.15.10104 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1199.15.10100 Boehringer Ingelheim Investigational Site
Bedford, Texas, United States
1199.15.10107 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1199.15.10108 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1199.15.10110 Boehringer Ingelheim Investigational Site
Fort Worth, Texas, United States
1199.15.10007 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
United States, Washington
1199.15.10105 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
1199.15.10112 Boehringer Ingelheim Investigational Site
Vancouver, Washington, United States
Australia, New South Wales
1199.15.61006 Boehringer Ingelheim Investigational Site
Camperdown, New South Wales, Australia
1199.15.61001 Boehringer Ingelheim Investigational Site
Waratah, New South Wales, Australia
Australia, Queensland
1199.15.61004 Boehringer Ingelheim Investigational Site
Herston, Queensland, Australia
1199.15.61003 Boehringer Ingelheim Investigational Site
Milton, Queensland, Australia
Australia, South Australia
1199.15.61005 Boehringer Ingelheim Investigational Site
Woodville, South Australia, Australia
Australia, Victoria
1199.15.61007 Boehringer Ingelheim Investigational Site
Parkville, Victoria, Australia
Australia, Western Australia
1199.15.61002 Boehringer Ingelheim Investigational Site
Nedlands, Western Australia, Australia
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, Austria
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, Belgium
Canada, British Columbia
1199.15.11005 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
Canada, Ontario
1199.15.11004 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1199.15.11008 Boehringer Ingelheim Investigational Site
London, Ontario, Canada
1199.15.11009 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
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
Czech Republic
1199.15.42002 Boehringer Ingelheim Investigational Site
Brno, Czech Republic
1199.15.42003 Boehringer Ingelheim Investigational Site
Olomouc, Czech Republic
1199.15.42001 Boehringer Ingelheim Investigational Site
Prague, Czech Republic
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, Denmark
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, Finland
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
1199.15.33045 Boehringer Ingelheim Investigational Site
Saint Cloud, France
1199.15.33030 Boehringer Ingelheim Investigational Site
Saint-Brieuc cedex, 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, France
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
1199.15.49004 Boehringer Ingelheim Investigational Site
Bonn, Germany
1199.15.49042 Boehringer Ingelheim Investigational Site
Bonn, Germany
1199.15.49071 Boehringer Ingelheim Investigational Site
Bottrop, Germany
1199.15.49081 Boehringer Ingelheim Investigational Site
Böblingen, 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
1199.15.49066 Boehringer Ingelheim Investigational Site
Essen, Germany
1199.15.49089 Boehringer Ingelheim Investigational Site
Essen, Germany
1199.15.49010 Boehringer Ingelheim Investigational Site
Essen, Germany
1199.15.49045 Boehringer Ingelheim Investigational Site
Frankfurt, Germany
1199.15.49068 Boehringer Ingelheim Investigational Site
Freiburg, Germany
1199.15.49011 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
1199.15.49087 Boehringer Ingelheim Investigational Site
Ludwigsburg, Germany
1199.15.49019 Boehringer Ingelheim Investigational Site
Lübeck, 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, Germany
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, Greece
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, Italy
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
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, Norway
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, Poland
Portugal
1199.15.35104 Boehringer Ingelheim Investigational Site
Coimbra, Portugal
1199.15.35102 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, Portugal
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, Russian Federation
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, Slovakia
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, Spain
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, Sweden
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, Ukraine
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 Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01015118     History of Changes
Other Study ID Numbers: 1199.15, AGO-OVAR12, 2008-006831-10
Study First Received: November 9, 2009
Last Updated: March 27, 2014
Health Authority: Australia: Human Research Ethics Committee
Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: The Danish Health and Medicines Authority
Finland: Finnish Medicines Agency
France: Agence Nationale sécurité médicament et des produits santé
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Italy: Ethics Committee
Monaco: Ministère de l'Etat
Netherlands: Central Committee Research Involving Human Subjects
Norway: Norwegian Medicines Agency
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Carboplatin
Nintedanib
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 24, 2014