EUCTR2016-002822-35-FR进行中（未招募）1 期
Treatment with azacitidine of recurrent gliomas with IDH1/2 mutation: AGIR - AGIR
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
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 > or equal 18 years
- •2) Glioma grade II or III with IDH1 or IDH2 mutation
- •3) Recurring after standard treatment, ie radiotherapy and alkylant chemotherapy, or alkylant chemotherapy alone in case of gliomatosis cerebri
- •4) For the patients treated by radiotherapy, recurrence occurring more than three months from the end of the radiotherapy or occurring outside the irradiated volume
- •5) Karnofsky performans status >50
- •6) Life expectancy > 9 months
- •7) Living within the geographic perimeter of the APHP home hospitalization center (departments 75,92,93,94)
- •8) Suitable laboratory values obtained ? 7 days before inclusion visit:
- •- Absolute neutrophil count (ANC) ?1500 /mm3
- •- Leucocytes > or equal 3,0 x 109/L
- •- Platelet count > or equal 75 000 / mm3
- •- Hemoglobin > 9.0 g/dL
- •- SGOT (AST) < or equal 3 x ULN
- •- SGPT (ALT) < or equal 3 x ULN
- •- Uremia < or equal 1.5 x ULN
- •- Creatininemia < or equal 1.5 x ULN
- •- Bicarbonates > or equal 22 mmol/l
- •9) Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must :
- •o Have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study.
- •o Agree to use, and to be able to comply with, effective contraception without interruption, throughout the entire duration study drug therapy (including doses interruptions) and for 3 months after the end of the study drug therapy.
- •10) Male patients :
- •o must agree to use a condom if engaged in sexual activity with a woman of childbearing potential during the entire period of treatment and during 3 months after end of treatment.
- •o are informed about the procedures for preservation of sperm before starting treatment.
- •11) Written informed consent dated and signed, prior to any study specific procedures (sampling, treatment and analyses).
- •12) Affiliation to the french health insurance (recipient or assign)
- •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 57
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1) Breast-feeding women and pregnancy
- •2) Any evidence of severe or uncontrolled systemic diseases (as judged by the investigator), including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) (Screening for chronic conditions is not required).
- •3) Active pulmonary disease or congestive cardiac insufficiency
- •4) Malignant hepatic tumor at a later stage
- •5) Intracranial hypertension or important deviation of the midline on the MRI
- •6) Any investigational agents or study drugs from a previous clinical study (within 30 days before the first dose of study treatment
- •7) Any chemotherapy, anticancer immunotherapy or anticancer agents within 4 weeks (6 weeks for nitrosourea) before the first dose of study treatment,
- •8) Any unresolved toxicities (excepted alopecia), from prior therapy greater than CTCAE grade 1 at the time of inclusion.
- •9) Known hypersensitivity to Azacitidine or Mannitol (E421), (refer to the Investigator's Brochure).
研究者
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