ISRCTN05858391已完成1 期
A Phase Ib study of eltrombopag and azacitidine in patients with high risk myelodysplastic syndromes and related disorders
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age >=16 years of age
- •2. Platelet count at baseline <150 x 109/l
- •3. Myelodysplastic Syndromes (MDS) classified as Intermediate 2 risk or high risk according to the International Prognostic Scoring System (IPSS) at registration or Chronic Myelomonocytic Leukaemia (CMML) with 10-29% bone marrow blasts without proliferation (peripheral white blood cell count <13 x 109/l) or Acute Myeloid Leukaemia (AML) with 20-30% bone marrow blast
- •4. Subjects must have platelet count and platelet transfusion data available over a period of 4 weeks prior to registration
- •5. A baseline bone marrow examination to evaluate blast percentage, karyotype and assessment of fibrotic change within 8 weeks of registraton
- •6. Alanine Aminotransferase ALT/Aspartate Aminotransferase (AST) < 3 x upper limit of normal ECOG = 2
- •7. Valid informed consent
- •Target Gender: Male & Female ; Lower Age Limit 16 years
排除标准
- •1. AML with >30% blasts
- •2. Known HIV positive
- •3. Known liver cirrhosis
- •4. Uncontrolled infection (grade 4 CTCAE v4)
- •5. Previous exposure to azacitidine
- •6. Previous exposure to thrombomimetic agents
- •7. Use of prior investigational agents within 6 weeks
- •8. Other severe, concurrent diseases or mental disorders
- •9. Concurrent active or previous malignancy within the last 3 years except controlled, localised prostate cancer on hormone therapy or non-melanoma skin malignancy or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situ
- •10. Bone marrow fibrosis
- •11. Clinical evidence of splenomegaly
- •12. Known hypersensitivity to study drugs or any of their excipients
- •13. Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)
- •14. Females of childbearing potential (i.e. not postmenopausal
- •or surgically sterilised) who are not willing to use adequate methods of contraception to prevent pregnancy or abstain from heterosexual activity for the duration of the trial and for at least 3 months following treatment discontinuation.
- •15. Male patients who are not willing to use an adequate method of contraception for the duration of the trial treatment if engaged in sexual activity with a female of childbearing potential and for at least 3 months following treatment discontinuation
- •16. Patients of east Asian ancestry*
- •* Patients will be excluded if either parent is East Asian (such as Chinese, Japanese, Taiwanese or Korean). In previous studies, the pharmacokinetics of eltrombopag in patients of East Asian ancestry differs significantly from the non-East Asian patients. The SPC for eltrombopag recommends patients receive 50% of the recommended dose. As this is a dose finding study, inclusion of these patients may impair an accurate finding of MTD and OBD that could be applied to the UK population.
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