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Brief Title: Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag
Official Title: A Randomized, Blinded, Placebo-controlled, Two-Phase, Sequential Cohort, Dose Finding Study to Assess the Safety and Efficacy of an Oral Thrombopoietin Receptor Agonist, Eltrombopag (SB-497115-GR), Administered to Patients With Solid Tumors Receiving Gemcitabine Monotherapy or the Combination of Gemcitabine Plus Carboplatin or Cisplatin
Study ID: NCT01147809
Brief Summary: The present study is a randomized, blinded, placebo-controlled, two-Phase, sequential cohort, dose finding study to assess the safety and efficacy of eltrombopag in patients with solid tumors receiving gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin. Phase I of the study will examine safety and tolerability of various doses of eltrombopag to identify a dose and schedule of eltrombopag. Phase II will confirm that the chosen dose and schedule of eltrombopag from Phase I can deliver clinically meaningful benefit(s) to thrombocytopenic patients by improving platelet numbers.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GSK Investigational Site, Sedona, Arizona, United States
GSK Investigational Site, Hot Springs, Arkansas, United States
GSK Investigational Site, Rancho Cucamonga, California, United States
GSK Investigational Site, Norwich, Connecticut, United States
GSK Investigational Site, Jacksonville, Florida, United States
GSK Investigational Site, New Port Richey, Florida, United States
GSK Investigational Site, Rome, Georgia, United States
GSK Investigational Site, Savannah, Georgia, United States
GSK Investigational Site, Wichita, Kansas, United States
GSK Investigational Site, Bethesda, Maryland, United States
GSK Investigational Site, Rockville, Maryland, United States
GSK Investigational Site, Columbia, Missouri, United States
GSK Investigational Site, Las Vegas, Nevada, United States
GSK Investigational Site, Cherry Hill, New Jersey, United States
GSK Investigational Site, Albany, New York, United States
GSK Investigational Site, Greensboro, North Carolina, United States
GSK Investigational Site, Bend, Oregon, United States
GSK Investigational Site, Philadelphia, Pennsylvania, United States
GSK Investigational Site, Wynnewood, Pennsylvania, United States
GSK Investigational Site, Providence, Rhode Island, United States
GSK Investigational Site, Providence, Rhode Island, United States
GSK Investigational Site, Greenville, South Carolina, United States
GSK Investigational Site, Arlington, Texas, United States
GSK Investigational Site, Austin, Texas, United States
GSK Investigational Site, Bedford, Texas, United States
GSK Investigational Site, Dallas, Texas, United States
GSK Investigational Site, San Antonio, Texas, United States
GSK Investigational Site, Tyler, Texas, United States
GSK Investigational Site, Norfolk, Virginia, United States
GSK Investigational Site, Edmunds, Washington, United States
GSK Investigational Site, Tacoma, Washington, United States
GSK Investigational Site, Vancouver, Washington, United States
GSK Investigational Site, Yakima, Washington, United States
GSK Investigational Site, Charleroi, , Belgium
GSK Investigational Site, Leuven, , Belgium
GSK Investigational Site, Libramont, , Belgium
GSK Investigational Site, Namur, , Belgium
GSK Investigational Site, Edmonton, Alberta, Canada
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Olomouc, , Czech Republic
GSK Investigational Site, Praha 10, , Czech Republic
GSK Investigational Site, Praha 5, , Czech Republic
GSK Investigational Site, Helsinki, , Finland
GSK Investigational Site, Tampere, , Finland
GSK Investigational Site, Freiburg, Baden-Wuerttemberg, Germany
GSK Investigational Site, Augsburg, Bayern, Germany
GSK Investigational Site, Muenchen, Bayern, Germany
GSK Investigational Site, Muenchen, Bayern, Germany
GSK Investigational Site, Goslar, Niedersachsen, Germany
GSK Investigational Site, Hannover, Niedersachsen, Germany
GSK Investigational Site, Essen, Nordrhein-Westfalen, Germany
GSK Investigational Site, Dresden, Sachsen, Germany
GSK Investigational Site, Dresden, Sachsen, Germany
GSK Investigational Site, Berlin, , Germany
GSK Investigational Site, Berlin, , Germany
GSK Investigational Site, Athens, , Greece
GSK Investigational Site, Athens, , Greece
GSK Investigational Site, Heraklion, Crete, , Greece
GSK Investigational Site, Thessaloniki, , Greece
GSK Investigational Site, Budapest, , Hungary
GSK Investigational Site, Győr, , Hungary
GSK Investigational Site, Kaposvár, , Hungary
GSK Investigational Site, Törökbálint, , Hungary
GSK Investigational Site, Zalaegerszeg, , Hungary
GSK Investigational Site, Madurai, , India
GSK Investigational Site, Pune, , India
GSK Investigational Site, Pune, , India
GSK Investigational Site, Dublin, , Ireland
GSK Investigational Site, Dublin, , Ireland
GSK Investigational Site, Tallaght, Dublin, , Ireland
GSK Investigational Site, Ashkelon, , Israel
GSK Investigational Site, Haifa, , Israel
GSK Investigational Site, Jerusalem, , Israel
GSK Investigational Site, Kfar Saba, , Israel
GSK Investigational Site, Tel Aviv, , Israel
GSK Investigational Site, Zrifin, , Israel
GSK Investigational Site, Modena, Emilia-Romagna, Italy
GSK Investigational Site, Aviano (PN), Friuli-Venezia-Giulia, Italy
GSK Investigational Site, Milano, Lombardia, Italy
GSK Investigational Site, Sassari, Sardegna, Italy
GSK Investigational Site, Pisa, Toscana, Italy
GSK Investigational Site, Bialystok, , Poland
GSK Investigational Site, Konin, , Poland
GSK Investigational Site, Olsztyn, , Poland
GSK Investigational Site, Poznan, , Poland
GSK Investigational Site, Poznan, , Poland
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR