EUCTR2016-000133-40-ES进行中（未招募）1 期
European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors - AcSé-ESMART
Gustave Roussy0 个研究点目标入组 285 人开始时间: 2017年11月28日最近更新:
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
- 285
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 must be diagnosed with a malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists.
- •2.Age < 18 years at inclusion; patients 18 years and older may be included after discussion with the sponsor if they have a pediatric recurrent/refractory malignancy.
- •3.Patients must have had advanced molecular profiling of their recurrent or refractory tumor i.e. at the time of disease progression/relapse; exceptionally patients with advanced molecular profiling at diagnosis may be allowed.
- •4.Evaluable or measurable disease as defined by standard imaging criteria for the patient’s tumor type (RECIST v1.1, RANO criteria for patients with HGG, INRC criteria for patients with NB, Leukemia criteria, etc.).
- •5.Patients with relapsed or refractory leukemia are eligible for this study.
- •6.Performance status: Karnofsky performance status (for patients >12 years of age) or Lansky Play score (for patients =12 years of age) = 70%.
- •7.Life expectancy = 3 months
- •8.Adequate organ function:
- •9.Able to comply with scheduled follow-up and with management of toxicity.
- •10.Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment.
- •11.For all oral medications patients must be able to comfortably swallow capsules (except for those for which an oral solution is available; nasogastric or gastrostomy feeding tube administration is allowed only if indicated).
- •12.Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study-specific screening procedures are conducted, according to local, regional or national guidelines.
- •13.Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 285
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS disease. Patients on stable doses of corticosteroids for at least 7 days prior to receiving study drug may be included.
- •2.Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
- •3.Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening)
- •4.Active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
- •5.Presence of any = CTCAE grade 2 treatment-related toxicity with the exception of alopecia, ototoxicity and peripheral neuropathy.
- •6.Systemic anticancer therapy within 21 days of the first study dose or 5 times its half-life, whichever is less.
- •7.Previous myeloablative therapy with autologous hematopoietic stem cell rescue within 8 weeks of the first study dose
- •8.Allogeneic stem cell transplant within 3 months prior to the first dose. Patients receiving any agent to treat or prevent graft-versus-host disease (GVHD) post bone marrow transplant are not eligible for this trial.
- •9.Radiotherapy (non-palliative) within 21 days prior to the first dose of drug (or within 6 weeks for therapeutic doses of MIBG or craniospinal irradiation).
- •10.Major surgery within 21 days of the first dose. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48 hour interval must be maintained before the first dose of the investigational drug is administered.
- •11.Currently taking medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes (Refer to Appendix 8).
- •12.Currently taking medications that are mainly metabolized by CYP3A4/5, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or the drug transporters Pgp (MDR1), BCRP, OATP1B1, OATP1B3, OCT1 and OCT2 and have a low therapeutic index that cannot be discontinued at least 7 days or 5 x reported elimination half-life prior to start of treatment with any of the investigational drugs and for the duration of the study (Refer to Appendix 9).
- •13.Known hypersensitivity to any study drug or component of the formulation.
- •14.Pregnant or nursing (lactating) females.
- •15.Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug.
研究者
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