A Phase 3 interventional study of Eltrombopag and Placebo in Solid Tumor, sponsored by Chang Gung Memorial Hospital. Status unknown at 3 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-24.
Sponsored by Chang Gung Memorial Hospital · Phase 3, Interventional, and Treatment
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 .
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.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's planned enrollment of 83 is above the median of 55 across 472 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
serum creatinine ≤ 1.5 × ULN (CTCAE Grade 1).
Exclusion Criteria:
Eligible patients will be enrolled randomly in 2:1 ratio to Investigational Drug (Eltrombopag) arm, 50 mg/day, or placebo arm for 7 days.
Drug: Eltrombopag
Eligible patients will be enrolled randomly in 2:1 ratio to Investigational Drug (Eltrombopag) arm, 50 mg/day, or placebo arm for 7 days
Drug: Placebo
This will be a Phase III, randomized, double-blind, placebo-controlled clinical trial. Qualified subjects will be randomly assigned to receive either the test treatment or the placebo at 2:1 ratio. Once subjects are randomized, they will be treated with Arm A: Eltrombopag 50 mg/day (n=55) or Arm B: placebo (n=28) once a day for 7 days.
Also known as: Revolade
This will be a Phase III, randomized, double-blind, placebo-controlled clinical trial. Qualified subjects will be randomly assigned to receive either the test treatment or the placebo at 2:1 ratio. Once subjects are randomized, they will be treated with Arm A: Eltrombopag 50 mg/day (n=55) or Arm B: placebo (n=28) once a day for 7 days.
efficacy of eltrombopag (50mg once daily)
Evaluate the efficacy of eltrombopag (50mg once daily) compared to the placebo by assessment of response rate
Time frame: up to treatment eltrombopag 7 days
safety and feasibility of 7-day eltrombopag
Number of Participants with Chemotherapy-induced thrombocytopenia to assess safety and feasibility to Change from Baseline in use eltrombopag at 7 days
Time frame: up to treatment eltrombopag 7 days
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital