Date: 2014-06-25
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: GSK (UK) Ligand Pharmaceuticals (USA - CA)
Product: eltrombopag (Promacta™/Revolade™) in combination with azacitidine
Action
mechanism: thrombopoietin agonist. Eltrombopag works by helping to induce proliferation and differentiation of bone marrow stem cells to increase production of blood cells.
Disease: myelodysplastic syndromes
Therapeutic area: Cancer - Oncology
Country: Republic of Korea, Russian Federation, Thailand
Trial
details: SUPPORT (StUdy of eltromboPag in myelodysPlastic SyndrOmes Receiving azaciTidine) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study of eltrombopag or placebo in combination with azacitidine in subjects with myelodysplastic syndromes (MDS). It is estimated that 350 patients across 30 countries and 156 study sites with a baseline platelet count of < 75Gi/L, and intermediate-1, intermediate-2 or high-risk MDS (by International Prognostic Scoring System) will be enrolled in the study. Eligible patients will be randomized to receive either eltrombopag (200 mg once daily [100 mg for East Asians]) plus azacitidine (75 mg/m2 subcutaneously once daily for 7 days) every 28 days, for at least 6 cycles, or placebo plus azacitidine. Dose modifications of eltrombopag or placebo will be permitted to ensure that patient platelet counts remain at a safe and effective level. The primary efficacy endpoint will determine the platelet supportive care effects of eltrombopag in combination with azacitidine versus placebo in combination with azacitidine by comparing the proportion of subjects receiving eltrombopag plus azacitidine who are platelet transfusion free during the first 4 cycles of azacitidine, versus those treated with placebo plus azacitidine. Secondary objectives will compare the following between treatment arms: overall survival, disease response, hematologic improvement, platelet and red blood cell transfusions, adverse events (≥ Grade 3), safety and tolerability, health-related quality of life and medical resource utilization. (NCT02158936)
Latest
news: * On June 25, 2014, Ligand Pharmaceuticals announced that its partner GSK plc has started a Phase 3 study to evaluate the platelet supportive care effects of eltrombopag (Promacta™/Revolade™) in combination with azacitidine (the current standard of care) versus placebo in combination with azacitidine in intermediate-1, intermediate-2 or high-risk patients with myelodysplastic syndromes (MDS). The global SUPPORT (TRC112121) study will assess the proportion of patients who are platelet transfusion free during the first four cycles of treatment.
