NCT01147809

Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag

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: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thrombocytopaenia

Interventions

Type	Name	Description
DRUG	Eltrombopag olamine	thrombopoietin receptor agonist
OTHER	Placebo	Placebo tablets with no active pharmaceutical ingredient

Timeline

• Start date: 2010-06-01
• Primary completion: 2015-01-01
• Completion: 2015-03-01
• First posted: 2010-06-22
• Last updated: 2016-04-18
• Results posted: 2016-04-18

Locations

86 sites across 13 countries: United States, Belgium, Canada, Czechia, Finland, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Poland