Conditions: Thrombocytopaenia
Keywords: Solid Tumor Eltrombopag chemotherapy-induced thrombocytopenia Thrombocytopenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

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:

Arms:
arm 1: Drug: eltrombopag olamine thrombopoietin receptor agonist arm 2: Other: Placebo Placebo tablets with no active pharmaceutical ingredient

Interventions: intervention 1: Eltrombopag olamine intervention 2: Placebo
Intervention descriptions: intervention 1: thrombopoietin receptor agonist intervention 2: Placebo tablets with no active pharmaceutical ingredient

Protocol document: