EUCTR2014-002752-50-FR进行中（未招募）1 期
Phase II clinical trial evaluating the efficacy of the dual inhibition of PIK/Akt/mTor signaling pathway by PF-05212384 (PKI-587) for patients with myeloid neoplasm secondary to chemo-radiotherapy (t-AML/MDS) or de novo relapsed or refractory AML - LAM-PIK
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •1. Patients belong to one of three categories:
- •1.1. Myeloid neoplasm secondary to chemo-radiotherapy (t-AML/MDS) aged 60 and over with unfavorable cytogenetics (ELN definition 2010), the first cancer must have been in remission for more than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
- •1.2. Relapsed or refractory de novo AML aged 18 and over (multiple relapses allowed), regardless of the risk group, provided not being eligible for allogeneic bone marrow transplantation
- •1.3. de novo AML at diagnosis, aged 60 and over and considered unfit to benefit from induction chemotherapy associated with aplasia (at the discretion of the investigator)
- •2. Adequate glycemic balance defined by glycated hemoglobin (HbA1c) = 8%
- •3. Females of childbearing potential (FCBP) should receive effective contraception: a negative pregnancy blood test is required within 2 weeks before starting experimental treatment.
- •4. ECOG/performance status = 2
- •5. Absence of severe or active infection
- •6. Adequate systolic cardiac function (LVEF = 50%)
- •7. Adequate hepatic function: AST and ALT = 3 times the upper limit of normal (ULN), bilirubin = 1.5 x ULN
- •8. Adequate renal function: serum creatinine = 1.5 x ULN or calculated creatinine clearance > 60 ml/min.
- •9. Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 39
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 39
排除标准
- •1. Glucose intolerance or diabetes mellitus, treated or untreated
- •2. First cancer in evolution(solid tumor or lymphoma) or in remission for less than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
- •3. AML secondary to MDS or myeloproliferative syndrome (WHO 2008 definitions)
- •4. Acute promyelocytic leukaemia (APL or AML FAB3) de novo or secondary to treatment (t-APL)
- •5. de novo or secondary CBF/AML
- •6. de novo or secondary Ph1 positive AML defined by the presence of a t(9.22) or a BCR-ABL transcript
- •7. Leukocytes above 30.000/mm3 (30 G/L) at enrollment
- •8. Antileukemic treatment within 15 days before enrollment, with the exception of hydroxyurea
- •9. Central nervous system leukemic involvement
- •10. Pregnant or lactating women, or women of childbearing potential without effective contraception
- •11. Prior history of allogeneic bone marrow transplantation
- •12. Prior history of organ transplantation or other cause of severe or chronic immunodeficiency
- •13. Seropositivity for HIV or HTLV-1 viruses, active B or C hepatitis
- •14. Inclusion in another experimental anti-cancer clinical trial*
- •15. Patients unable to undergo medical monitoring for geographical, social or psychological issues
- •16. Patient under measure of legal protection
- •17. No social security
研究者
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