NL-OMON49633招募中2 期
European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors (ESMART) - ESMART
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
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
- 年龄范围
- 2 至 64（—）
入选标准
- •1. Patients must be diagnosed with a haematologic or solid tumor malignancy
- •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. 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 (RECIST v1.1, RANO criteria
- •for patients with HGG, INRC criteria for patients with NB,
- •Leukemia criteria, etc.).
- •5. Performance status: Karnofsky performance status (for patients
- •>12 years of age) or Lansky Play score (for patients <=12 years of
- •age) >= 70%. Patients who are unable to walk because of paralysis
- •or stable neurological disability, but who are up in a wheelchair,
- •will be considered ambulatory for the purpose of assessing the
- •performance score.
- •6. Life expectancy >= 3 months
- •7. Adequate organ function:
- •Hematologic criteria (Leukemia patients are excluded from
- •hematological criteria):
- •- Peripheral absolute neutrophil count (ANC) >= 1000/µL
- •(unsupported)
- •- Platelet count >= 100,000/µL (unsupported)
- •- Hemoglobin >= 8.0 g/dL (transfusion is allowed)
- •Cardiac function:
- •- Shortening fraction (SF) >29% (>35% for children < 3 years)
- •and left ventricular ejection fraction (LVEF) >=50% at baseline, as
- •determined by echocardiography (mandatory only for patients
- •who have received cardiotoxic therapy).
- •- Absence of QTc prolongation (QTc > 450 msec on baseline
- •ECG, using the Fridericia correction [QTcF formula]) or other
- •clinically significant ventricular or atrial arrhythmia.
- •Renal and hepatic function:
- •- Serum creatinine <= 1.5 x upper limit of normal (ULN) for age
- •- Total bilirubin <= 1.5 x ULN
- •- Alanine aminotransferase (ALT)/serum glutamic pyruvic
- •transaminase (SGPT) <= 2.5 x ULN; aspartate aminotransferase
- •(AST)/serum glutamic oxaloacetic transaminase/SGOT <= 2.5 x ULN
- •except in patients with documented tumor involvement of the liver
- •who must have AST/SGOT and ALT/SGPT <= 5 x ULN.
- •8. Able to comply with scheduled follow-up and with management of
- •9. Females of childbearing potential must have a negative serum or
- •urine pregnancy test within 72 hours prior to initiation of treatment.
- •Sexually active women of childbearing potential must agree to use acceptable
- •and appropriate contraception during the study and for at least 6 months after
- 另有 10 项未显示
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, unstable ischemia, congestive
- •heart failure 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 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. 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
- •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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