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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00049998 |
Purpose
The purpose of this study is to collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC).
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small-Cell Lung Cancer |
Drug: topotecan |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer |
| Estimated Enrollment: | 760 |
| Study Start Date: | October 2001 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| Australia, South Australia | |
| GSK Investigational Site | |
| Bedford Park, South Australia, Australia, 5042 | |
| GSK Investigational Site | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| GSK Investigational Site | |
| Melbourne, Victoria, Australia, 3004 | |
| GSK Investigational Site | |
| Ringwood East, Victoria, Australia, 3128 | |
| Austria | |
| GSK Investigational Site | |
| Innsbruck, Austria, A-6020 | |
| GSK Investigational Site | |
| Vienna, Austria, A-1220 | |
| GSK Investigational Site | |
| St Poelten, Austria, A-3100 | |
| Belgium | |
| GSK Investigational Site | |
| Edegem, Belgium, 2650 | |
| GSK Investigational Site | |
| Liege, Belgium, 4000 | |
| GSK Investigational Site | |
| Bruxelles, Belgium, 1200 | |
| GSK Investigational Site | |
| Braasschaat, Belgium, 2930 | |
| Canada, Nova Scotia | |
| GSK Investigational Site | |
| Sydney, Nova Scotia, Canada, B1P 1P3 | |
| Canada, Ontario | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| GSK Investigational Site | |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| GSK Investigational Site | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M6S 1B5 | |
| Canada, Quebec | |
| GSK Investigational Site | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| GSK Investigational Site | |
| Sainte-Foy, Quebec, Canada, G1V 4G5 | |
| GSK Investigational Site | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| China | |
| GSK Investigational Site | |
| Wangfujing, Beijing, China, 100730 | |
| GSK Investigational Site | |
| Shanghai, China | |
| GSK Investigational Site | |
| Tianjin, China | |
| GSK Investigational Site | |
| Shanghai, China, 200433 | |
| GSK Investigational Site | |
| Beijing, China, 100036 | |
| China, Shaanxi | |
| GSK Investigational Site | |
| Xian, Shaanxi, China, 710061 | |
| Czech Republic | |
| GSK Investigational Site | |
| Ceske Budejovice, Czech Republic, 370 87 | |
| GSK Investigational Site | |
| Praha 4, Czech Republic, 140 59 | |
| GSK Investigational Site | |
| Kladno, Czech Republic, 140 59 | |
| Denmark | |
| GSK Investigational Site | |
| Odense C, Denmark, DK-5000 | |
| GSK Investigational Site | |
| Herlev, Denmark | |
| Finland | |
| GSK Investigational Site | |
| Helsinki, Finland, 00029 | |
| GSK Investigational Site | |
| Turku, Finland, 20520 | |
| France | |
| GSK Investigational Site | |
| Dijon Cedex, France, 21079 | |
| GSK Investigational Site | |
| Caen Cedex 5, France, 14076 | |
| GSK Investigational Site | |
| Vesoul Cedex, France, 70014 | |
| GSK Investigational Site | |
| Toulon Naval, France, 83800 | |
| GSK Investigational Site | |
| Strasbourg Cedex, France, 67098 | |
| Germany | |
| GSK Investigational Site | |
| Berlin, Germany, 14109 | |
| GSK Investigational Site | |
| Hamburg, Germany, 21075 | |
| Germany, Bayern | |
| GSK Investigational Site | |
| Regensburg, Bayern, Germany, 93049 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80336 | |
| GSK Investigational Site | |
| Gauting, Bayern, Germany, 82131 | |
| Germany, Brandenburg | |
| GSK Investigational Site | |
| Treuenbrietzen, Brandenburg, Germany, 14929 | |
| Germany, Sachsen | |
| GSK Investigational Site | |
| Leipzig, Sachsen, Germany, 04207 | |
| Germany, Thueringen | |
| GSK Investigational Site | |
| Bad Berka, Thueringen, Germany, 99437 | |
| Greece | |
| GSK Investigational Site | |
| Athens, Greece, 11526 | |
| GSK Investigational Site | |
| Heraklion, Crete, Greece, 71110 | |
| GSK Investigational Site | |
| Rio, Patras, Greece, 265 00 | |
| GSK Investigational Site | |
| Papagos, Athens, Greece, 15669 | |
| GSK Investigational Site | |
| Thessaloniki, Greece, 54007 | |
| Hungary | |
| GSK Investigational Site | |
| Miskolc, Hungary, 3529 | |
| GSK Investigational Site | |
| Budapest, Hungary, 1529 | |
| GSK Investigational Site | |
| Csorna, Hungary, 9300 | |
| Israel | |
| GSK Investigational Site | |
| Tel Aviv, Israel, 64239 | |
| GSK Investigational Site | |
| Beer-Sheva, Israel, 84101 | |
| GSK Investigational Site | |
| Ashkelon, Israel, 78306 | |
| GSK Investigational Site | |
| Ramat Gan, Israel, 52621 | |
| Italy, Lazio | |
| GSK Investigational Site | |
| Roma, Lazio, Italy, 00149 | |
| Italy, Piemonte | |
| GSK Investigational Site | |
| Torino, Piemonte, Italy, 10126 | |
| Italy, Sardegna | |
| GSK Investigational Site | |
| Sassari, Sardegna, Italy, 07100 | |
| Italy, Umbria | |
| GSK Investigational Site | |
| Perugia, Umbria, Italy, 06122 | |
| Italy, Veneto | |
| GSK Investigational Site | |
| Verona, Veneto, Italy, 37135 | |
| Latvia | |
| GSK Investigational Site | |
| Riga, Latvia, LV 1079 | |
| GSK Investigational Site | |
| Riga, Latvia, LV 1002 | |
| Lithuania | |
| GSK Investigational Site | |
| Vilnius, Lithuania, LT-08660 | |
| GSK Investigational Site | |
| Kaunas, Lithuania, LT-50009 | |
| Netherlands | |
| GSK Investigational Site | |
| GRONINGEN, Netherlands, 9721 SW | |
| GSK Investigational Site | |
| DELFT, Netherlands, 2625 AD | |
| GSK Investigational Site | |
| 's-HERTOGENBOSCH, Netherlands, 5211 NL | |
| GSK Investigational Site | |
| HEERLEN, Netherlands, 6419 PC | |
| GSK Investigational Site | |
| LEEUWARDEN, Netherlands, 8934 AD | |
| New Zealand | |
| GSK Investigational Site | |
| Newtown, Wellington, New Zealand, 6002 | |
| Philippines | |
| GSK Investigational Site | |
| Quezon City, Philippines, 1100 | |
| Poland | |
| GSK Investigational Site | |
| Poznan, Poland, 60-569 | |
| GSK Investigational Site | |
| Warszawa, Poland, 02-781 | |
| Portugal | |
| GSK Investigational Site | |
| Porto, Portugal, 4200-319 | |
| GSK Investigational Site | |
| Lisboa, Portugal, 1769-166 | |
| Russian Federation | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 117 837 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 129 128 | |
| GSK Investigational Site | |
| St. Petersburg, Russian Federation, 198255 | |
| GSK Investigational Site | |
| Samara, Russian Federation, 443066 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 115 478 | |
| GSK Investigational Site | |
| N. Novgorod, Russian Federation, 603 000 | |
| Singapore | |
| GSK Investigational Site | |
| Singapore, Singapore, 119074 | |
| South Africa | |
| GSK Investigational Site | |
| Port Elizabeth, South Africa, 6001 | |
| South Africa, Gauteng | |
| GSK Investigational Site | |
| Pretoria, Gauteng, South Africa | |
| South Africa, Western Province | |
| GSK Investigational Site | |
| Cape Town, Western Province, South Africa | |
| GSK Investigational Site | |
| Cape Town, Western Province, South Africa | |
| Spain | |
| GSK Investigational Site | |
| Valencia, Spain, 46009 | |
| GSK Investigational Site | |
| Lerida, Spain, 25198 | |
| GSK Investigational Site | |
| Barakaldo (Vizcaya), Spain, 48903 | |
| GSK Investigational Site | |
| Malaga, Spain, 29020 | |
| GSK Investigational Site | |
| Jaen, Spain, 23007 | |
| GSK Investigational Site | |
| Madrid, Spain, 28040 | |
| GSK Investigational Site | |
| La Laguna (Santa Cruz de Tenerife), Spain, 38320 | |
| GSK Investigational Site | |
| Madrid, Spain, 28047 | |
| GSK Investigational Site | |
| Pontevedra, Spain, 36002 | |
| GSK Investigational Site | |
| Madrid, Spain, 28007 | |
| GSK Investigational Site | |
| Palma de Mallorca, Spain, 07014 | |
| Switzerland | |
| GSK Investigational Site | |
| Zurich, Switzerland, CH-8091 | |
| Taiwan | |
| GSK Investigational Site | |
| Taipei, Taiwan, 100 | |
| GSK Investigational Site | |
| Tau-Yuan County, Taiwan, 333 | |
| Thailand | |
| GSK Investigational Site | |
| Bangkok, Thailand, 10400 | |
| GSK Investigational Site | |
| Chiang Mai, Thailand, 50200 | |
| Turkey | |
| GSK Investigational Site | |
| Istanbul, Turkey, 34280 | |
| GSK Investigational Site | |
| Izmir, Turkey, 3510 | |
| Ukraine | |
| GSK Investigational Site | |
| Lvov, Ukraine, 79031 | |
| GSK Investigational Site | |
| Lugansk, Ukraine | |
| GSK Investigational Site | |
| Kharkov, Ukraine | |
| United Kingdom | |
| GSK Investigational Site | |
| London, United Kingdom, SE1 9RT | |
| United Kingdom, Forfarshire | |
| GSK Investigational Site | |
| Dundee, Forfarshire, United Kingdom, DD1 9SY | |
| United Kingdom, Lanarkshire | |
| GSK Investigational Site | |
| Glasgow, Lanarkshire, United Kingdom, G4 0SF | |
| United Kingdom, Leicestershire | |
| GSK Investigational Site | |
| Leicester, Leicestershire, United Kingdom, LE1 5WW | |
| United Kingdom, Nottinghamshire | |
| GSK Investigational Site | |
| Nottingham, Nottinghamshire, United Kingdom | |
| United Kingdom, Surrey | |
| GSK Investigational Site | |
| Guildford, Surrey, United Kingdom, GU2 7XX | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 104864-A/387 |
| Study First Received: | November 18, 2002 |
| Last Updated: | October 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00049998 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Nonsmall Cell Lung cancer advanced Second-line topotecan |
Hycamtin oral docetaxel |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Pharmacologic Actions Carcinoma Docetaxel |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Topotecan Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |