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Brief Title: SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adult Cancer Patients Receiving Chemotherapy
Official Title: A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel Group, Dose Ranging Study to Assess the Efficacy, Safety, and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist(SB497115-GR) Administered at 50, 75, and 100 mg to Cancer Patients Receiving Multiple Cycles of Chemotherapy
Study ID: NCT00102726
Brief Summary: SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 versus placebo as treatment for patients with advanced solid tumors scheduled to receive chemotherapy with carboplatin and paclitaxel every 21 days. Patients will receive SB497115 on days 2-11 of each 21 day cycle for at least 2 cycles of chemotherapy and for a maximum of 8 cycles of chemotherapy.
Detailed Description: A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel Group, Dose Ranging Study to Assess the Efficacy, Safety, and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist (SB-497115-GR) Administered at 50, 75, and 100 mg to Cancer Patients Receiving Multiple Cycles of Chemotherapy
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GSK Investigational Site, Tucson, Arizona, United States
GSK Investigational Site, Jonesboro, Arkansas, United States
GSK Investigational Site, Greenbrae, California, United States
GSK Investigational Site, Long Beach, California, United States
GSK Investigational Site, Los Angeles, California, United States
GSK Investigational Site, Los Angeles, California, United States
GSK Investigational Site, Colorado Springs, Colorado, United States
GSK Investigational Site, Newark, Delaware, United States
GSK Investigational Site, Boca Raton, Florida, United States
GSK Investigational Site, Hollywood, Florida, United States
GSK Investigational Site, Tamarac, Florida, United States
GSK Investigational Site, Savannah, Georgia, United States
GSK Investigational Site, Metairie, Louisiana, United States
GSK Investigational Site, Baltimore, Maryland, United States
GSK Investigational Site, Minneapolis, Minnesota, United States
GSK Investigational Site, Hattiesburg, Mississippi, United States
GSK Investigational Site, Tupelo, Mississippi, United States
GSK Investigational Site, Las Vegas, Nevada, United States
GSK Investigational Site, Babylon, New York, United States
GSK Investigational Site, New York, New York, United States
GSK Investigational Site, Durham, North Carolina, United States
GSK Investigational Site, Akron, Ohio, United States
GSK Investigational Site, Mayfield Heights, Ohio, United States
GSK Investigational Site, Toledo, Ohio, United States
GSK Investigational Site, Bryan, Texas, United States
GSK Investigational Site, Ogden, Utah, United States
GSK Investigational Site, Salem, Virginia, United States
GSK Investigational Site, Capital Federal, Buenos Aires, Argentina
GSK Investigational Site, La Plata, Buenos Aires, Argentina
GSK Investigational Site, Rosario, Santa Fe, Argentina
GSK Investigational Site, Rosario, Santa Fe, Argentina
GSK Investigational Site, Buenos Aires, , Argentina
GSK Investigational Site, Buenos Aires, , Argentina
GSK Investigational Site, Vienna, , Austria
GSK Investigational Site, Vienna, , Austria
GSK Investigational Site, Vienna, , Austria
GSK Investigational Site, Plovdiv, , Bulgaria
GSK Investigational Site, Sofia, , Bulgaria
GSK Investigational Site, Sofia, , Bulgaria
GSK Investigational Site, Sofia, , Bulgaria
GSK Investigational Site, Brno, , Czech Republic
GSK Investigational Site, Praha 8, , Czech Republic
GSK Investigational Site, Freiburg, Baden-Wuerttemberg, Germany
GSK Investigational Site, Regensburg, Bayern, Germany
GSK Investigational Site, Marburg, Hessen, Germany
GSK Investigational Site, Hemer, Nordrhein-Westfalen, Germany
GSK Investigational Site, Trier, Rheinland-Pfalz, Germany
GSK Investigational Site, Grosshansdorf, Schleswig-Holstein, Germany
GSK Investigational Site, Bad Berka, Thueringen, Germany
GSK Investigational Site, Berlin, , Germany
GSK Investigational Site, Hamburg, , Germany
GSK Investigational Site, Budapest, , Hungary
GSK Investigational Site, Székesfehérvár, , Hungary
GSK Investigational Site, Bangalore, , India
GSK Investigational Site, Hyderabad, Andhra Pradesh, , India
GSK Investigational Site, Kolkatta, , India
GSK Investigational Site, Vellore, , India
GSK Investigational Site, Benevento, Campania, Italy
GSK Investigational Site, Roma, Lazio, Italy
GSK Investigational Site, Milano, Lombardia, Italy
GSK Investigational Site, Campobasso, Molise, Italy
GSK Investigational Site, Seoul, , Korea, Republic of
GSK Investigational Site, Seoul, , Korea, Republic of
GSK Investigational Site, Merida, Yucatán, Mexico
GSK Investigational Site, Lima, , Peru
GSK Investigational Site, Olsztyn, , Poland
GSK Investigational Site, Poznan, , Poland
GSK Investigational Site, Poznan, , Poland
GSK Investigational Site, Szczecin, , Poland
GSK Investigational Site, Wroclaw, , Poland
GSK Investigational Site, Bucuresti, , Romania
GSK Investigational Site, Moscow Region, , Russian Federation
GSK Investigational Site, Moscow, , Russian Federation
GSK Investigational Site, Moscow, , Russian Federation
GSK Investigational Site, Moscow, , Russian Federation
GSK Investigational Site, St. Petersburg, , Russian Federation
GSK Investigational Site, St. Petersburg, , Russian Federation
GSK Investigational Site, Badalona, , Spain
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Cordoba, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Santa Cruz de Tenerife, , Spain
GSK Investigational Site, Santander, , Spain
GSK Investigational Site, Sevilla, , Spain
GSK Investigational Site, Taipei, , Taiwan
GSK Investigational Site, Tau-Yuan County, , Taiwan
GSK Investigational Site, Dnepropetrovsk, , Ukraine
GSK Investigational Site, Donetsk, , Ukraine
GSK Investigational Site, Kyiv, , Ukraine
GSK Investigational Site, Lvov, , Ukraine
GSK Investigational Site, Truro, Cornwall, United Kingdom
GSK Investigational Site, Chelmsford, Essex, United Kingdom
GSK Investigational Site, Colchester, , United Kingdom
GSK Investigational Site, Dundee, , United Kingdom
GSK Investigational Site, Leicester, , United Kingdom
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR