EUCTR2015-000140-42-BE进行中（未招募）1 期
A Phase 3 Open-Label, Multicenter, Randomized Study of ASP2215 versus Salvage Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with FLT3 Mutation - ADMIRA
Astellas Pharma Global Development, Inc. (APGD)0 个研究点目标入组 369 人开始时间: 2015年9月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 369
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject is eligible for the study if all of the following apply:
- •1. Institutional Review Board-/Independent Ethics Committee-approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act Authorization for United States sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- •2. Subject is considered an adult according to local regulation at the time of signing informed consent.
- •3. Subject has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) according to World Health Organization classification [Swerdlow et al, 2008] as determined by pathology review at the treating institution.
- •4. Subject is refractory to or relapsed after first-line AML therapy (with or without HSCT).
- •Refractory to first-line AML therapy is defined as:
- •a) Subject did not achieve CR/CRi/CRp under initial therapy. A subject eligible for standard therapy must receive at least 1 cycle of an anthracycline containing induction block in standard dose for the selected induction regimen. A subject not eligible for standard therapy must have received at least 1 complete block of induction therapy seen as the optimum choice of therapy to induce remission for this subject as per investigator’s assessment.
- •Untreated first hematologic relapse is defined as:
- •a) Subject must have achieved a CR/CRi/CRp (criteria as defined by [Cheson et al, 2003], see Section 5.3) with first line treatment and has hematologic relapse.
- •5. Subject is positive for FLT3 activating mutation in bone marrow or whole blood as determined by central lab. In the investigator’s opinion, a subject with rapidly proliferative disease and unable to wait for the central lab results can be enrolled based on local tests.
- •6. Subject has an ECOG performance status = 2.
- •7. Subject is eligible for preselected salvage chemotherapy according to investigator assessment.
- •8. Subject must meet the following criteria as indicated on the clinical laboratory tests:
- •Serum aspartate aminotransferase and alanine aminotransferase = 2.5 x upper limit of normal
- •Serum total bilirubin = 1.5 x ULN
- •Serum creatinine = 1.5 x ULN or an estimated glomerular filtration rate of > 50 mL/min as
- •calculated by the Modification of Diet in Renal Disease equation.
- •9. Subject is suitable for oral administration of study drug.
- •10. Female subject must either:
- •Be of nonchild bearing potential:
- •- postmenopausal (defined as at least 1 year without any menses) prior to screening, or
- •- documented surgically sterile (at least 1 month prior to screening)
- •Or, if of childbearing potential,
- •- Agree not to try to become pregnant during the study and for 45 days after the final study drug administration
- •- And have a negative urine pregnancy test at screening
- •- And, if heterosexually active, agree to consistently use 2 forms of effective contraception per locally accepted standards (1 of which must be a barrier method) starting at screening and throughout the study period and for 45 days after the final study drug administration.
- •11. Female subject must agree not to breastfeed at screening and throughout the study period and for 45 days after the final study drug administration.
- •12. Female subject must not donate ova starting at screening and throughout the study period and for 45
排除标准
- •Subject will be excluded from participation if any of the following apply:
- •1. Subject was diagnosed as acute promyelocytic leukemia.
- •2. Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
- •3. Subject has AML secondary to prior chemotherapy for other neoplasms (except for MDS).
- •4. Subject is in second or later hematologic relapse or has received salvage therapy for refractory disease.
- •5. Subject has clinically active central nervous system leukemia.
- •6. Subject has been diagnosed with another malignancy, unless disease-free for at least 5 years. Subjects with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Subjects with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed or treated with definitive radiotherapy.
- •7. Subject has received prior treatment with ASP2215 or other FLT3 inhibitors (with the exception of sorafenib used in first-line therapy regimen as part of induction, consolidation and/or maintenance).
- •8. Subject has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation.
- •9. Subject has had major surgery within 4 weeks prior to the first study dose.
- •10. Subject has radiation therapy within 4 weeks prior to the first study dose.
- •11. Subject has congestive heart failure New York Heart Association (NYHA) class 3 or 4 or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 1 month prior to study entry results in a left ventricular ejection fraction that is = 45%
- •12. Subjects with mean of triplicate Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading.
- •13. Subjects with Long QT Syndrome at Screening.
- •14. Subjects with hypokalemia and hypomagnesemia at Screening (defined as values below lower limit of normal [LLN]).
- •15. Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP) 3A.
- •16. Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) or substrates of multidrug and toxin extrusion protein 1 (MATE1) with the exception of drugs that are considered absolutely essential for the care of the subject.
- •17. Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.
- •18. Subject has an active uncontrolled infection.
- •19. Subject is known to have human immunodeficiency virus infection.
- •20. Subject has active hepatitis B or C or other active hepatic disorder.
- •21. Subject has any condition which, in the investigator’s opinion, makes the subject unsuitable for study participation.
- •22. Subject has active clinically significant GVHD or is on treatment with systemic corticosteroids for GVHD.
- •Waivers to the exclusion criteria will NOT be allowed.
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