OncoMatch/Clinical Trials/NCT02813135
European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
Is NCT02813135 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for pediatric cancer.
Treatment: Ribociclib · Topotecan · Temozolomide · Everolimus · Adavosertib · Carboplatin · Olaparib · Irinotecan · Vistusertib · Nivolumab · Cyclophosphamide · Selumetinib · Enasidenib · Lirilumab · Fadraciclib · Cytarabine · Dexamethasone · Ceralasertib · Futibatinib · Capmatinib · Avelumab · Peposertib · Capivasertib · Vinorelbine — This proof-of-concept platform trial is designed to cover the targeting of several survival pathways in oncogenesis that are currently not adequately employed for pediatric patients in Europe (Geoerger 2017; Geoerger 2019). The aims of the trial are: 1. To determine the recommended phase II dose (RP2D) of a specific anticancer agent and/or a relevant combination in a pediatric population, to document its tolerability and 2. To explore first signals of activity in a molecularly enriched study population.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Must have received: standard therapy — relapsed/refractory
has progressed despite standard therapy, or for which no effective standard therapy exists
Cannot have received: systemic anticancer therapy
Systemic anticancer therapy within 21 days of the first study dose or 5 times its half-life, whichever is less
Cannot have received: myeloablative therapy with autologous hematopoietic stem cell rescue
Previous myeloablative therapy with autologous hematopoietic stem cell rescue within 8 weeks of the first study drug dose
Cannot have received: allogeneic stem cell transplant
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.
Cannot have received: radiotherapy (non-palliative)
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)
Cannot have received: major surgery
Exception: 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
Major surgery within 21 days of the first dose
Lab requirements
Blood counts
Peripheral ANC ≥ 1000/μL (unsupported); Platelet count ≥ 100,000/μL (unsupported); Hemoglobin ≥ 8.0 g/dL (transfusion is allowed); Leukemia patients are excluded from hematological criteria
Kidney function
Serum creatinine ≤ 1.5 x ULN for age
Liver function
Total bilirubin ≤ 1.5 x ULN; ALT/SGPT ≤ 2.5 x ULN; AST/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
Cardiac function
Shortening fraction >29% (>35% for children < 3 years) and 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.
Adequate organ function: Hematologic criteria (Leukemia patients are excluded from hematological criteria): Peripheral ANC ≥ 1000/μL (unsupported); Platelet count ≥ 100,000/μL (unsupported); Hemoglobin ≥ 8.0 g/dL (transfusion is allowed). Cardiac function: Shortening fraction >29% (>35% for children < 3 years) and 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 ULN for age; Total bilirubin ≤ 1.5 x ULN; ALT/SGPT ≤ 2.5 x ULN; AST/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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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