A Comparative Study on Prophylactic use of Tablet Eltrombopag in varying doses to prevent Thrombocytopenia in Patients with Solid Tumour Malignancies receiving Gemcitabine based Chemotherapy : A Three armed, Prospective, Interventional Study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- To asses whether prophylactic use of Tablet Eltromobopag in different doses reduce the degree and duration of Gemcitabine based chemotherapy induced thrombocytopenia
研究概览
简要总结
A prospective study, patients aged more than 18years of age with solid malignancies scheduled for Gemcitabine based chemotherapy in any setting(Neo adjuvant,adjuvant ,palliative setting) will be included in the study.Gemcitabine Based Chemotherapy Will Be Given On Day 1 And Day8 Of Every 21 Day Cycle.One Day Prior To Every Chemotherapy Cycle CBC, RFTS, LFTS Will Be Checked. Patients will be taken under three arms.Arm A will receive Tablet Eltrombopag 50 mg orally daily for 7 days(Day 9-Day 15 of each cycle).Arm B will receive Tablet Eltrombopag 25 mg orally daily for 7 days(Day 9-Day 15 of each cycle).Arm C will be under observation(No Eltrombopag). Eltrombopag will be given as per assigned arm for 4 consecutive cycles will be given. Platelet counts trend will be observed across the 4 consecutive chemotherapy cycles. The efficacy of prophylactic use of Tablet Eltrombopagin various doses (25mg and 50mg) in preventing Gemcitabine based chemotherapy induced thrombocytopenia in patients with solid malignancies and Documentation of any chemotherapy Dose reductions or delays.Monitoring for adverse events and Toxicity will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.In patients with Histologically/cytologically confirmed solid malignancies.
- •2.Patients with ECOG performance status 0-
- •3.Patients scheduled for Gemcitabine based chemotherapy (monotherapy or in combination).
- •4.Signed, written informed consent 5.Adequate organ function(as per standard laboratory values).
排除标准
- •1.History of hematologic malignancy from bone marrow aspirate and biopsy or peripheral blood test in the prior 3 months.
- •2.Patients with pre-existing platelet count less than 1,00,000 cells/microL.
- •3.Patients with Active bleeding or coagulopathy.
- •4.Prior use of TPO receptor agonists 5.Patients with uncontrolled infection or uncontrolled Type 2 Diabetes Mellitus, Systemic Hypertension, chronic Diseases/ illness.
- •6.Pregnant women and lactating women.
结局指标
主要结局
To asses whether prophylactic use of Tablet Eltromobopag in different doses reduce the degree and duration of Gemcitabine based chemotherapy induced thrombocytopenia
时间窗: After 4 consecutive cycles of chemotherapy
次要结局
- To assess whether the Tablet Eltrombopag is safe and adverse effect profile.(After every cycle for 4 consecutive cycles)
研究者
Dr Chilamkurty Maitreyi
Stanley Medical College and Hospital,Chennai