LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00805194
First received: December 8, 2008
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: placebo plus docetaxel
Drug: BIBF 1120 plus docetaxel
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: Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Docetaxel Therapy Compared to Placebo Plus Standard Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cell Lung Cancer After Failure of First Line Chemotherapy

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tumour response, [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • quality of life, [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence and intensity of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics of BIBF 1120 [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • overall survival, [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1300
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBF 1120 plus docetaxel
BIBF 1120 2 times daily along with standard therapy of docetaxel
Drug: BIBF 1120 plus docetaxel
BIBF 1120 2 times daily along with standard therapy of docetaxel
Placebo Comparator: Placebo plus docetaxel
Placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel
Drug: placebo plus docetaxel
placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • male or female patient aged 18 years or older;
  • histologically or cytologically confirmed, locally advanced and/or metastatic NSCLC of stage IIIB or IV or recurrent NSCLC;
  • relapse or failure of one first line prior chemotherapy;
  • at least one target tumour lesion that has not been irradiated within the past three months and that can accurately be measured ;
  • life expectancy of at least three months;
  • ECOG score of 0 or 1;
  • patient has given written informed consent

Exclusion criteria:

  • more than one prior chemotherapy regimen for advanced and/or metastatic or recurrent NSCLC;
  • more than one chemotherapy treatment regimen (either neoadjuvant or adjuvant or neoadjuvant plus adjuvant) prior to first line chemotherapy;
  • previous therapy with other VEGFR inhibitors (other than bevacizumab) or docetaxel for treatment of NSCLC;
  • persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy;
  • treatment with other investigational drugs or other anti-cancer therapy or treatment in another clinical trial within the past four weeks before start of - therapy or concomitantly with this trial ;
  • radiotherapy (except extremities and brain) within the past three months prior to baseline imaging;
  • active brain metastases or leptomeningeal disease;
  • radiographic evidence of cavitary or necrotic tumours;
  • centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels;
  • history of clinically significant haemoptysis within the past 3 months;
  • therapeutic anticoagulation (except low dose heparin) or antiplatelet therapy;
  • history of major thrombotic or clinically relevant major bleeding event in the past 6 months;
  • known inherited predisposition to bleeding or thrombosis;
  • significant cardiovascular diseases ;
  • inadequate safety laboratory parameters;
  • significant weight loss (> 10 %) within the past 6 weeks;
  • current peripheral neuropathy greater than CTCAE grade 2 except due to trauma;
  • preexisting ascites and/or clinically significant pleural effusion;
  • major injuries and/or surgery within the past ten days prior to randomisation with incomplete wound healing;
  • serious infections requiring systemic antibiotic therapy;
  • decompensated diabetes mellitus or other contraindication to high dose corticosteroid therapy;
  • gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug;
  • active or chronic hepatitis C and/or B infection;
  • serious illness or concomitant non-oncological disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration;
  • patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial and for at least twelve months after 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;
  • patients unable to comply with the protocol;
  • active alcohol or drug abuse;
  • other malignancy within the past three years other than basal cell skin cancer, or carcinoma in situ of the cervix;
  • any contraindications for therapy with docetaxel;
  • history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80);
  • hypersensitivity to BIBF 1120 and/or the excipients of the trial drugs;
  • hypersensitivity to contrast media
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805194

  Hide Study Locations
Locations
Austria
1199.13.4003 Boehringer Ingelheim Investigational Site
Graz, Austria
1199.13.4004 Boehringer Ingelheim Investigational Site
Kufstein, Austria
1199.13.4001 Boehringer Ingelheim Investigational Site
Linz, Austria
Belarus
1199.13.6003 Boehringer Ingelheim Investigational Site
Bobruisk, Belarus
1199.13.6004 Boehringer Ingelheim Investigational Site
Brest region, Belarus
1199.13.6002 Boehringer Ingelheim Investigational Site
Gomel, Belarus
1199.13.6007 Boehringer Ingelheim Investigational Site
Minsk, Belarus
1199.13.6005 Boehringer Ingelheim Investigational Site
Minsk region, Belarus
1199.13.6001 Boehringer Ingelheim Investigational Site
Mogilov, Belarus
1199.13.6006 Boehringer Ingelheim Investigational Site
Vitebsk, Belarus
Belgium
1199.13.4101 Boehringer Ingelheim Investigational Site
Liège, Belgium
1199.13.4102 Boehringer Ingelheim Investigational Site
Liège, Belgium
Bulgaria
1199.13.6106 Boehringer Ingelheim Investigational Site
Gabrovo, Bulgaria
1199.13.6102 Boehringer Ingelheim Investigational Site
Pleven, Bulgaria
1199.13.6104 Boehringer Ingelheim Investigational Site
Plovdiv, Bulgaria
1199.13.6105 Boehringer Ingelheim Investigational Site
Ruse, Bulgaria
1199.13.6103 Boehringer Ingelheim Investigational Site
Shumen, Bulgaria
1199.13.6101 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
China
1199.13.8120 Boehringer Ingelheim Investigational Site
Beijing, China
1199.13.8121 Boehringer Ingelheim Investigational Site
Changchun, China
1199.13.8108 Boehringer Ingelheim Investigational Site
Changchun, China
1199.13.8113 Boehringer Ingelheim Investigational Site
Chengdu, China
1199.13.8115 Boehringer Ingelheim Investigational Site
Chongqing, China
1199.13.8103 Boehringer Ingelheim Investigational Site
Dalian, China
1199.13.8114 Boehringer Ingelheim Investigational Site
Dalian, China
1199.13.8117 Boehringer Ingelheim Investigational Site
Fujian, China
1199.13.8110 Boehringer Ingelheim Investigational Site
Guangzhou, China
1199.13.8116 Boehringer Ingelheim Investigational Site
Guangzhou, China
1199.13.8111 Boehringer Ingelheim Investigational Site
Hangzhou, China
1199.13.8118 Boehringer Ingelheim Investigational Site
Hangzhou, China
1199.13.8123 Boehringer Ingelheim Investigational Site
Harbin, China
1199.13.8112 Boehringer Ingelheim Investigational Site
Nanjing, China
1199.13.8109 Boehringer Ingelheim Investigational Site
Nanjing, China
1199.13.8105 Boehringer Ingelheim Investigational Site
Shanghai, China
1199.13.8119 Boehringer Ingelheim Investigational Site
Shanghai, China
1199.13.8101 Boehringer Ingelheim Investigational Site
Shanghai, China
1199.13.8104 Boehringer Ingelheim Investigational Site
Wuhan, China
1199.13.8102 Boehringer Ingelheim Investigational Site
Xuhui area, Shanghai, China
Croatia
1199.13.6201 Boehringer Ingelheim Investigational Site
Zagreb, Croatia
1199.13.6202 Boehringer Ingelheim Investigational Site
Zagreb, Croatia
Czech Republic
1199.13.6305 Boehringer Ingelheim Investigational Site
Brno, Czech Republic
1199.13.6303 Boehringer Ingelheim Investigational Site
Brno, Czech Republic
1199.13.6302 Boehringer Ingelheim Investigational Site
Liberec, Czech Republic
1199.13.6306 Boehringer Ingelheim Investigational Site
Nova Ves pod Plesi, Czech Republic
1199.13.6304 Boehringer Ingelheim Investigational Site
Pribram, Czech Republic
Denmark
1199.13.4201 Boehringer Ingelheim Investigational Site
Herlev, Denmark
1199.13.4202 Boehringer Ingelheim Investigational Site
Odense C, Denmark
France
1199.13.4401 Boehringer Ingelheim Investigational Site
Lyon Cedex 4, France
1199.13.4405 Boehringer Ingelheim Investigational Site
Marseille Cedex 9, France
1199.13.4408 Boehringer Ingelheim Investigational Site
Pierre Bénite cedex, France
1199.13.4409 Boehringer Ingelheim Investigational Site
ROUEN cedex, France
1199.13.4411 Boehringer Ingelheim Investigational Site
Saint Herblain cedex, France
1199.13.4404 Boehringer Ingelheim Investigational Site
Saint-Priest en Jarez, France
1199.13.4407 Boehringer Ingelheim Investigational Site
Strasbourg cedex, France
1199.13.4403 Boehringer Ingelheim Investigational Site
Toulon Cedex 09, France
Georgia
1199.13.6401 Boehringer Ingelheim Investigational Site
Tbilisi, Georgia
1199.13.6404 Boehringer Ingelheim Investigational Site
Tbilisi, Georgia
1199.13.6403 Boehringer Ingelheim Investigational Site
Tbilisi, Georgia
1199.13.6402 Boehringer Ingelheim Investigational Site
Tbilisi, Georgia
Germany
1199.13.4530 Boehringer Ingelheim Investigational Site
Augsburg, Germany
1199.13.4523 Boehringer Ingelheim Investigational Site
Bad Berka, Germany
1199.13.4501 Boehringer Ingelheim Investigational Site
Berlin, Germany
1199.13.4510 Boehringer Ingelheim Investigational Site
Berlin, Germany
1199.13.4543 Boehringer Ingelheim Investigational Site
Berlin-Buch, Germany
1199.13.4534 Boehringer Ingelheim Investigational Site
Frankfurt, Germany
1199.13.4503 Boehringer Ingelheim Investigational Site
Frankfurt/Main, Germany
1199.13.4508 Boehringer Ingelheim Investigational Site
Frankfurt/Main, Germany
1199.13.4522 Boehringer Ingelheim Investigational Site
Freiburg, Germany
1199.13.4505 Boehringer Ingelheim Investigational Site
Gauting, Germany
1199.13.4514 Boehringer Ingelheim Investigational Site
Großhansdorf, Germany
1199.13.4520 Boehringer Ingelheim Investigational Site
Halle/Saale, Germany
1199.13.4524 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1199.13.4521 Boehringer Ingelheim Investigational Site
Heidelberg, Germany
1199.13.4541 Boehringer Ingelheim Investigational Site
Kassel, Germany
1199.13.4516 Boehringer Ingelheim Investigational Site
Kiel, Germany
1199.13.4519 Boehringer Ingelheim Investigational Site
Köln, Germany
1199.13.4506 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1199.13.4512 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1199.13.4525 Boehringer Ingelheim Investigational Site
Löwenstein, Germany
1199.13.4502 Boehringer Ingelheim Investigational Site
Lübeck, Germany
1199.13.4532 Boehringer Ingelheim Investigational Site
Mainz, Germany
1199.13.4531 Boehringer Ingelheim Investigational Site
Mainz, Germany
1199.13.4529 Boehringer Ingelheim Investigational Site
München, Germany
1199.13.4515 Boehringer Ingelheim Investigational Site
München, Germany
1199.13.4527 Boehringer Ingelheim Investigational Site
München, Germany
1199.13.4511 Boehringer Ingelheim Investigational Site
Oldenburg, Germany
1199.13.4542 Boehringer Ingelheim Investigational Site
Tübingen, Germany
1199.13.4533 Boehringer Ingelheim Investigational Site
Wiesbaden, Germany
1199.13.4526 Boehringer Ingelheim Investigational Site
Witten, Germany
Greece
1199.13.4607 Boehringer Ingelheim Investigational Site
Athens, Greece
1199.13.4603 Boehringer Ingelheim Investigational Site
Heraklio, Greece
1199.13.4602 Boehringer Ingelheim Investigational Site
Holargos, Athens, Greece
1199.13.4606 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
1199.13.4601 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
India
1199.13.8321 Boehringer Ingelheim Investigational Site
Ahmedabad, India
1199.13.8302 Boehringer Ingelheim Investigational Site
Bangalore, India
1199.13.8305 Boehringer Ingelheim Investigational Site
Bangalore, India
1199.13.8314 Boehringer Ingelheim Investigational Site
Bhopal, M.P., India
1199.13.8308 Boehringer Ingelheim Investigational Site
Chennai, India
1199.13.8315 Boehringer Ingelheim Investigational Site
Jaipur, India
1199.13.8313 Boehringer Ingelheim Investigational Site
Jaipur, India
1199.13.8320 Boehringer Ingelheim Investigational Site
Jaipur, Rajasthan, India
1199.13.8318 Boehringer Ingelheim Investigational Site
Kolkata, West Bengal, India
1199.13.8304 Boehringer Ingelheim Investigational Site
Mangalore, India
1199.13.8312 Boehringer Ingelheim Investigational Site
Mumbai, India
1199.13.8311 Boehringer Ingelheim Investigational Site
Nashik, India
1199.13.8309 Boehringer Ingelheim Investigational Site
New Delhi, India
1199.13.8303 Boehringer Ingelheim Investigational Site
New Delhi, India
1199.13.8310 Boehringer Ingelheim Investigational Site
New Delhi, India
1199.13.8316 Boehringer Ingelheim Investigational Site
Pune, Maharahtra, India
1199.13.8319 Boehringer Ingelheim Investigational Site
Trivandrum, Kerala, India
1199.13.8322 Boehringer Ingelheim Investigational Site
Vijayawada, India
1199.13.8323 Boehringer Ingelheim Investigational Site
Visakhapatnam, India
Israel
1199.13.4705 Boehringer Ingelheim Investigational Site
Holon, Israel
1199.13.4704 Boehringer Ingelheim Investigational Site
Jerusalem, Israel
1199.13.4702 Boehringer Ingelheim Investigational Site
Kfar Saba, Israel
1199.13.4703 Boehringer Ingelheim Investigational Site
Tel Hashomer, Israel
1199.13.4707 Boehringer Ingelheim Investigational Site
Tel-Aviv, Israel
1199.13.4701 Boehringer Ingelheim Investigational Site
Zerifin, Israel
Italy
1199.13.4805 Boehringer Ingelheim Investigational Site
Ancona, Italy
1199.13.4810 Boehringer Ingelheim Investigational Site
Aviano, Italy
1199.13.4803 Boehringer Ingelheim Investigational Site
Bologna, Italy
1199.13.4806 Boehringer Ingelheim Investigational Site
Brescia, Italy
1199.13.4812 Boehringer Ingelheim Investigational Site
Firenze, Italy
1199.13.4814 Boehringer Ingelheim Investigational Site
Ivrea, Italy
1199.13.4813 Boehringer Ingelheim Investigational Site
Meldola, Italy
1199.13.4809 Boehringer Ingelheim Investigational Site
Milano, Italy
1199.13.4815 Boehringer Ingelheim Investigational Site
Orbassano, Italy
1199.13.4811 Boehringer Ingelheim Investigational Site
Pavia, Italy
1199.13.4802 Boehringer Ingelheim Investigational Site
Perugia, Italy
Korea, Republic of
1199.13.8503 Boehringer Ingelheim Investigational Site
Gangdong-gu, Seoul, Korea, Republic of
1199.13.8502 Boehringer Ingelheim Investigational Site
Incheon, Korea, Republic of
1199.13.8501 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Lithuania
1199.13.6503 Boehringer Ingelheim Investigational Site
Kaunas, Lithuania
1199.13.6502 Boehringer Ingelheim Investigational Site
Siauliai, Lithuania
1199.13.6501 Boehringer Ingelheim Investigational Site
Vilnius, Lithuania
Poland
1199.13.6601 Boehringer Ingelheim Investigational Site
Bydgoszcz, Poland
1199.13.6612 Boehringer Ingelheim Investigational Site
Elblag, Poland
1199.13.6606 Boehringer Ingelheim Investigational Site
Olsztyn, Poland
1199.13.6605 Boehringer Ingelheim Investigational Site
Otwock, Poland
1199.13.6608 Boehringer Ingelheim Investigational Site
Poznan, Poland
1199.13.6613 Boehringer Ingelheim Investigational Site
Slupsk, Poland
1199.13.6609 Boehringer Ingelheim Investigational Site
Suwalki, Poland
1199.13.6604 Boehringer Ingelheim Investigational Site
Szczecin, Poland
1199.13.6610 Boehringer Ingelheim Investigational Site
Warszawa, Poland
Portugal
1199.13.4908 Boehringer Ingelheim Investigational Site
Coimbra, Portugal
1199.13.4902 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1199.13.4905 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1199.13.4904 Boehringer Ingelheim Investigational Site
Porto, Portugal
1199.13.4906 Boehringer Ingelheim Investigational Site
Porto, Portugal
1199.13.4901 Boehringer Ingelheim Investigational Site
Setúbal, Portugal
1199.13.4903 Boehringer Ingelheim Investigational Site
Vila Nova de Gaia, Portugal
Romania
1199.13.6709 Boehringer Ingelheim Investigational Site
Baia Mare, Romania
1199.13.6705 Boehringer Ingelheim Investigational Site
Brasov, Romania
1199.13.6706 Boehringer Ingelheim Investigational Site
Bucuresti, Romania
1199.13.6707 Boehringer Ingelheim Investigational Site
Cluj-Napoca, Romania
1199.13.6703 Boehringer Ingelheim Investigational Site
Hunedoara, Romania
1199.13.6704 Boehringer Ingelheim Investigational Site
Iasi, Romania
1199.13.6711 Boehringer Ingelheim Investigational Site
Iasi, Romania
1199.13.6710 Boehringer Ingelheim Investigational Site
Onesti, Romania
1199.13.6701 Boehringer Ingelheim Investigational Site
Suceava, Romania
1199.13.6702 Boehringer Ingelheim Investigational Site
Timisoara, Romania
Russian Federation
1199.13.6823 Boehringer Ingelheim Investigational Site
Arkhangelsk, Russian Federation
1199.13.6801 Boehringer Ingelheim Investigational Site
Chelyabinsk, Russian Federation
1199.13.6812 Boehringer Ingelheim Investigational Site
Irkutsk, Russian Federation
1199.13.6813 Boehringer Ingelheim Investigational Site
Kazan, Russian Federation
1199.13.6808 Boehringer Ingelheim Investigational Site
Kurski, Russian Federation
1199.13.6803 Boehringer Ingelheim Investigational Site
Magnitogorsk, Russian Federation
1199.13.6811 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1199.13.6820 Boehringer Ingelheim Investigational Site
Pyatigorsk, Russian Federation
1199.13.6810 Boehringer Ingelheim Investigational Site
Ryazan, Russian Federation
1199.13.6822 Boehringer Ingelheim Investigational Site
Sochi, Russian Federation
1199.13.6814 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1199.13.6815 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1199.13.6805 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1199.13.6802 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1199.13.6816 Boehringer Ingelheim Investigational Site
Yekaterinburg, Russian Federation
Slovakia
1199.13.6902 Boehringer Ingelheim Investigational Site
Trnava, Slovakia
South Africa
1199.13.5004 Boehringer Ingelheim Investigational Site
Durban, South Africa
1199.13.5005 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1199.13.5006 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1199.13.5001 Boehringer Ingelheim Investigational Site
Port Elizabeth, South Africa
1199.13.5003 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
1199.13.5007 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
1199.13.5002 Boehringer Ingelheim Investigational Site
Western Cape, South Africa
Spain
1199.13.5109 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1199.13.5103 Boehringer Ingelheim Investigational Site
Elche, Spain
1199.13.5112 Boehringer Ingelheim Investigational Site
Jerez de la Frontera-Cádiz, Spain
1199.13.5104 Boehringer Ingelheim Investigational Site
Madrid, Spain
1199.13.5102 Boehringer Ingelheim Investigational Site
Pozuelo de Alarcon, Spain
1199.13.5105 Boehringer Ingelheim Investigational Site
Valencia, Spain
1199.13.5107 Boehringer Ingelheim Investigational Site
Valencia, Spain
1199.13.5111 Boehringer Ingelheim Investigational Site
Valencia, Spain
Switzerland
1199.13.5303 Boehringer Ingelheim Investigational Site
Aarau, Switzerland
1199.13.5302 Boehringer Ingelheim Investigational Site
Baden, Switzerland
Ukraine
1199.13.7006 Boehringer Ingelheim Investigational Site
Chernigiv, Ukraine
1199.13.7007 Boehringer Ingelheim Investigational Site
Chernivtsi, Ukraine
1199.13.7008 Boehringer Ingelheim Investigational Site
Chmelnytskyi, Ukraine
1199.13.7012 Boehringer Ingelheim Investigational Site
Dnipropetrovks, Ukraine
1199.13.7002 Boehringer Ingelheim Investigational Site
Donetsk, Ukraine
1199.13.7005 Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
1199.13.7004 Boehringer Ingelheim Investigational Site
Kryvyi Rig, Ukraine
1199.13.7009 Boehringer Ingelheim Investigational Site
Odesa, Ukraine
1199.13.7001 Boehringer Ingelheim Investigational Site
Ternopil, Ukraine
1199.13.7013 Boehringer Ingelheim Investigational Site
Uzhgorod, Ukraine
1199.13.7010 Boehringer Ingelheim Investigational Site
Vinnytsia, Ukraine
United Kingdom
1199.13.5402 Boehringer Ingelheim Investigational Site
Bournemouth, United Kingdom
1199.13.5408 Boehringer Ingelheim Investigational Site
Bristol, United Kingdom
1199.13.5401 Boehringer Ingelheim Investigational Site
Chelmsford, United Kingdom
1199.13.5406 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
1199.13.5407 Boehringer Ingelheim Investigational Site
Poole, 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: NCT00805194     History of Changes
Other Study ID Numbers: 1199.13, 2007-004803-36
Study First Received: December 8, 2008
Last Updated: April 16, 2014
Health Authority: Austria: Agency for Health and Food Safety
Belarus: Ministry of Health of Republic of Belarus
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
China: SDFA
Croatia: Ministry of Health and Social Welfare of the Republic of Croatia
Czech Republic: State Institute for Drug Control
Denmark: The Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Georgia: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: Medicines and Heathcare Products Regulatory Agency
Greece: Ministry of health & social solidarity national organization for medicines
India: Central Drug Standard Control Organization
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Korea, Republic of: KFDA
Lithuania: Lithuanian Bioethics Committee
Poland: Agency for Registration of Medicinal Products, Medical Devices & Biocides
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Federal Supervising Service for Public Health and Social Development of the Ministry of Health and Social Development of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: The Registrar, Department of Health, Medicines Control Council
Spain: Medicines and Healthcare Products Agency
Switzerland: Swissmedic
Ukraine: State Pharmacological Centre of Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014