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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 11 Feb 2019

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At a glance

  • Drugs Eltrombopag (Primary)
  • Indications Solid tumours; Thrombocytopenia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors GlaxoSmithKline

    • Most Recent Events

    • 01 Dec 2017 Primary endpoint (Phase II: Effect of eltrombopag compared to placebo on the scheduled Day 1 pre-chemotherapy platelet counts will be evaluated across all cycles in the study) has not been met, according to the results published in the International Journal of Hematology
    • 01 Dec 2017 Results published in the International Journal of Hematology
    • 20 Apr 2016 Time frame for primary endpoints has been changed.
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