EUCTR2016-000133-40-NL进行中（未招募）1 期
European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors - ACSE-ESMART
Gustave Roussy0 个研究点目标入组 460 人开始时间: 2017年12月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 460
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 hematologic or solid tumor malignancy that has progressed or relapsed despite standard therapy, or for which no effective standard therapy exists.
- •2.Age <18 years at inclusion.
- •3.Patient must have had advanced molecular profiling (i.e. WES/WGS +/- RNAseq) 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.
- •5.Performance status: Karnofsky performance status (for patients >12 years of age) or Lansky Play score (for patients =12 years of age) =70%.
- •6.Life expectancy =3 months.
- •7.Adequate organ function
- •8.Able to comply with scheduled follow-up and with management of toxicity.
- •9.Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to initiation of treatment.
- •10.For all oral medications patients must be able to comfortably swallow capsules or tablets
- •11.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.
- •12.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: 460
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 81
- •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.
- •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).
- •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 or 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 drug dose
- •8.Allogeneic stem cell transplant within 3 months prior to the first study drug 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.
- •11.Currently taking medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes.
- •12.Known hypersensitivity to any study drug or component of the formulation.
- •13.Pregnant or nursing (lactating) females.
- •14.Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug.
研究者
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