NCT02438761终止2 期
Phase II Evaluating the Efficacy of the Dual Inhibition of Phosphoinositide 3 Kinase (PI3K)/Akt /Mammalian Target Of Rapamycine (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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 5
- 主要终点
- To evaluate the efficacy of PF-05212384
研究概览
简要总结
Phase II open-label single-arm prospective multicentric clinical trial of PF-05212384 (PKI-587) delivered by intravenous route. A 2-stage Fleming design will be employed.
详细描述
The treatment is administered in cycles of 28 days for a period of 4 cycles. Patients will be treated on a weekly basis continuously during 112 days or until progression.
Blood tests (hemogram) are assessed weekly before each injection of PF-05212384 (PKI-587). Bone marrow aspiration (myelogram) is performed to evaluate the response before starting treatment and before the start of cycle 3 (after two cycles) and at the end of the study (after four cycles). Good responders who continue treatment after four cycles will be evaluated by bone marrow aspiration (myelogram) every two cycles and after the end of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients belong to one of three categories:
- •Myeloid neoplasm secondary to chemo-radiotherapy (t-AML/MDS) aged 60 and over with unfavorable cytogenetics (European Leukemia Network 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
- •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
- •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)
- •Adequate glycemic balance defined by glycated hemoglobin ≤ 8%
- •Females of childbearing potential (FCBP) should receive effective contraception: a negative pregnancy blood test is required within 2 weeks before starting experimental treatment.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
- •Absence of severe or active infection
- •Adequate systolic cardiac function : Left Ventricular Ejection Fraction (LVEF) ≥ 50%
- •Adequate hepatic function: Aspartate Aminotransferase Test (AST) and Alanine Aminotransferase Test (ALT) ≤ 3 times the upper limit of normal (ULN), bilirubin ≤ 1.5 x ULN
- •Adequate renal function: serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance > 60 ml/min.
- •Signed informed consent
排除标准
- •Glucose intolerance or diabetes mellitus, treated or untreated
- •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
- •AML secondary to MDS or myeloproliferative syndrome (WHO 2008 definitions)
- •Acute Promyelocytic Leukaemia (APL or AML French American British (FAB) classification 3) de novo or secondary to treatment (t-APL)
- •de novo or secondary Core Binding Factor (CBF)/AML
- •de novo or secondary Philadelphia Chromosome (Ph) 1 positive AML defined by the presence of a t(9.22) or a Breakpoint Cluster Region-Abelson Murine Leukemia Viral Oncogene Homolog (BCR-ABL) transcript
- •Leukocytes above 30.000/mm3 (30 G/L) at enrollment
- •Antileukemic treatment within 15 days before enrollment, with the exception of hydroxyurea
- •Central nervous system leukemic involvement
- •Pregnant or lactating women, or women of childbearing potential without effective contraception
- •Prior history of allogeneic bone marrow transplantation
- •Prior history of organ transplantation or other cause of severe or chronic immunodeficiency Human
- •Seropositivity for Human Immunodeficiency Virus (HIV) or Human T-Lymphotropic Virus-1 (HTLV-1) viruses, active B or C hepatitis
- •Inclusion in another experimental anti-cancer clinical trial*
- •Patients unable to undergo medical monitoring for geographical, social or psychological issues
- •Patient under measure of legal protection
- •No social security
- •For ethical reasons, the exclusion period before considering the possibility of participating in another clinical study with a new experimental molecule cannot be determined, yet each case will be discussed on an individual basis with the study coordinator.
研究组 & 干预措施
PF-05212384
Experimental
150 mg Intra-venous every week
干预措施: PF-05212384 (Drug)
结局指标
主要结局
To evaluate the efficacy of PF-05212384
时间窗: 4 months after treatment
The overall response rate will be assessed according to the International Working Group (IWG) AML and MDS criteria (by B.D. Cheson).
次要结局
- Treatment compliance(4 months)
- Progressive Free Survival (PFS)(one year)
- Overall survival(48 months)
- Tolerance and toxicity during treatment(4 months)
- Evaluation of Quality of life(4 months)
研究者
研究点 (5)
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