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.

Abstract:

OBJECTIVES:Eltrombopag, 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 METHODS:Patients (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 NUMBER:NCT00102726. RESULTS:Although 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. CONCLUSIONS:This 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.

journal_name

Curr Med Res Opin

authors

Kellum A,Jagiello-Gruszfeld A,Bondarenko IN,Patwardhan R,Messam C,Mostafa Kamel Y

doi

10.1185/03007995.2010.510051

subject

Has Abstract

pub_date

2010-10-01 00:00:00

pages

2339-46

issue

10

eissn

0300-7995

issn

1473-4877

journal_volume

26

pub_type

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