Clinical Trials

Clinical Trials

RECRUITING

Phase 2:

• LuPARPed. Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined with the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed). NCT06607692. Eligible patients: 
  • =< 18 years at diagnosis, no age limit at inclusion
  • Relapsed/refractory tumours expressing somatostatin receptors: HGG, meningioma, medulloblastoma, neuroblastoma, lymphomas, paraganglioma, pheochromocytoma, osteosarcoma...
  • Treatment with Lutathera + olaparib

                    For more information: https://clinicaltrials.gov/study/NCT06607692  Dra Marta Osuna (Principal Investigator).                                                                 mail: marta.osuna@startmadrid.com

• TPX-0005-07. A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations. NCT04094610. Eligible patients:  
  • Children, adolescents and young adults up to 25 years with tumours that have:
    • Fusion in NTRK treated with one or two prior lines of NTRK inhibitors, with measurable disease or no
    • ROS1 fusion in first or more lines of treatment.
  • Treatment with repotrectinib

                  For more information: https://clinicaltrials.gov/study/NCT04094610  Dra Marta Osuna (Principal Investigator).                                                                 mail: marta.osuna@startmadrid.com

• I3Y-MC-JPEH. A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy. NCT06413706. Eligible patients:  
  • Children, adolescents and young adults up to 21 years. 
  • Newly diagnosed high-grade glioma (HGG) after completion of radiotherapy.
  • Treatment randomised 1:2 between temozolamide vs temozolamide+abemaciclib.

                  For more information: https://clinicaltrials.gov/study/NCT06413706  Dra Marta Osuna (Principal Investigator).                                                                 mail: marta.osuna@startmadrid.com

Phase 3:

• PHITT. Paediatric Hepatic International Tumour Trial. EudraCT Nr. 2016-002828-85. Eligible patients: 
  • Age <= 30 años
  • Newly diagnosed liver tumours: hepatoblastoma, hepatocarcinoma.

Phase 4:

• LCH-IV: International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis. EudraCT Nr.: 2011-001699-20. Eligible patients: 
  • Age <18 years
  • Newly diagnosed or relapsed Langerhans Cell Histiocytosis (LCH).

• UMBRELLA PROTOCOL SIOP-RTSG 2016. EudraCT number: 2016-004180-39. Since 2019 – present. Eligible patients: 
  • Any age (except for renal carcinoma which are only <18 years).
  • Renal tumours: Wilms tumour (nephroblastoma), renal clear cell sarcomas, renal carcinoma, malignant rhabdoid tumour of the kidney, mesoblastic nephroma, other renal tumours.

• EpSSG NRSTS 2005. EudraCT number: 2005-001139-31. Eligible patients: 
  • Age <21 years.
  • Localised non-rhabdoid soft tissue sarcomas: de novo synovial sarcoma, adult soft tissue sarcoma (fibrosarcoma, malignant peripheral sheath tumours, epithelioid sarcoma, leiosarcoma, clear cell sarcoma, liposarcoma alveolar sarcoma angiosarcoma dermatofibrosarcoma protuberans...), other histologies.

WITHOUT RECRUITMENT

• Intergroup Randomized Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Rituximab Evaluation in High Risk Patients.
  Duration: 2012 to present.
   
• D3820C00016. A Phase I, Open label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages > 6 Months to < 18 Years receiving Treatment  with Opioids.
  Duration:  2014 to present.
   
• XM22-08. An opened labeled randomized active-control multicenter study to evaluate the efficacy, pharmacokinetics, pharmacodynamics safety tolerability and immunogenicity of lipegfilgrastim 100 mcg/Kg body weight in comparation to filgrastim 5 mcg/Kg body weight in pediatric patients diagnosed with Ewing family of tumors or rhabdomyosarcoma receiving chemotherapy. Phase II. 
  Duration: 2015 to present.
   
• A three month prospective open label study of therapy with fragmin (registered) (dalteparin sodium injection) in children with venous thromboembolism with or without malignancies. 
  Duration: 2017 to present.
   
• LOXO-TRK-15002. A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 in Subjects with NTRK Fusion-Positive Tumors.
  Duration: 2016 to present.