• Curr Med Res Opin · Oct 2010

    Randomized Controlled Trial Multicenter Study

    A randomized, double-blind, placebo-controlled, dose ranging study to assess the efficacy and safety of eltrombopag in patients receiving carboplatin/paclitaxel for advanced solid tumors.

    • A Kellum, A Jagiello-Gruszfeld, I N Bondarenko, R Patwardhan, C Messam, and Y Mostafa Kamel.
    • North Mississippi Hematology & Oncology Associates LTD, Tupelo, MO, USA.
    • Curr Med Res Opin. 2010 Oct 1; 26 (10): 2339-46.

    ObjectivesEltrombopag, an oral, nonpeptide thrombopoietin receptor agonist, has been shown to increase platelet counts in adults with chronic immune thrombocytopenia and chronic hepatitis C. This multicenter phase 2 study assessed the efficacy and safety of eltrombopag in patients receiving first-line carboplatin/paclitaxel for the treatment of advanced solid tumors.Research Design And MethodsPatients (N = 183) were randomized to placebo or eltrombopag 50 mg, 75 mg, or 100 mg given orally following chemotherapy on days 2 through 11 of each 21-day cycle, for at least two cycles. The primary endpoint was the difference in platelet count from day 1 in cycle 2 to the platelet nadir in cycle 2.Clinical Trial Registry NumberNCT00102726.ResultsAlthough the primary endpoint was not met, postnadir platelet counts increased during cycles 1 and 2 in all eltrombopag treatment groups compared with placebo. The most commonly reported adverse events across all study arms (including placebo) were nausea and alopecia and eltrombopag was generally well tolerated.ConclusionsThis study provides preliminary information that eltrombopag does increase platelets in patients receiving chemotherapy for advanced solid tumors. Further investigation is needed to identify the optimal dose(s) and schedule of eltrombopag in patients receiving myelosuppressive chemotherapy.

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