A Study to Assess the Efficacy and Safety of Eltrombopag as a Rescue of Isolated Chemotherapy-induced Thrombocytopenia

Solid Tumor Clinical Trial

Official title: A Randomized, Double Blind Placebo-controlled Study to Assess the Efficacy and Safety of Eltrombopag as a Rescue of Isolated Chemotherapy-induced Thrombocytopenia in Patients With Solid Tumor

Status Enrolling by invitation

Clinical Trial Summary

The purpose of this study is evaluate the efficacy and safety of eltrombopag as a rescue of isolated chemotherapy-induced thrombocytopenia in patients with solid tumor .

Clinical Trial Description

For the phase III study, a double-blind randomized, placebo controlled, parallel-group design will be conducted to evaluate the efficacy of eltombopag . Each subject will be randomly assigned to either Arm A (eltombopag) or Arm B (placebo) in 2:1 ratio.

The primary objective is to compare the response rates of the two treatment arms, Therefore, the two-proportion z test will be considered and sample size can be chosen to achieve an 95% power for detecting a clinically meaningful difference at level of significance=0.05. A difference of 40% in clinical response is considered of clinically meaningful difference between the two treatment arms (75% for eltombopag vs. 35% for placebo). It requires a total sample of 83 subjects (55 for eltombopag and 28 for placebo). According to the 10% loss of screening failure, 90-100 subjects (60-67 for eltombopag and 30-33 for placebo) will be recruited. ;

Related Conditions & MeSH terms

• Solid Tumor
• Thrombocytopenia

• NCT number: NCT02093325
• Study type: Interventional
• Source: Chang Gung Memorial Hospital
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: March 2014
• Completion date: August 2019