MedTrace Logo

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 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-14

No results posted yet for this study

Summary

Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)

Conditions

  • Solid Tumor Cancer
  • Medulloblastoma
  • High Risk Neuroblastoma
  • High Grade Gliomas
  • Meningioma
  • Paraganglioma
  • Pheochromocytoma
  • Neuroendocrine Tumours (NET)
  • Adrenal Tumours
  • DIPG
  • Glioblastoma
  • Glioblastoma (GBM)
  • Osteosarcoma Recurrent
  • Carcinoma Adrenal
  • Synovial Sarcomas
  • Esthesioneuroblastoma
  • Neuroblastoma Recurrent
  • Solid Tumor Refractory to Conventional Treatment
  • Medulloblastoma Recurrent
  • Paraganglioma/ Phaeochromocytoma

Interventions

DRUG

Olaparib; 177Lu-DOTATATE

7Lu-DOTATATE will be administered intravenously, on day 1, every 8 weeks, at a fixed dose of 200 mCi (7.4 GBq) for children \>= 12 years old infused intravenously over a period of 30 minutes. For children younger than 12 years old, the dose that will be administered is 200 MBq per kilogram of body weight (maximum 7.4 GBq) infused intravenously over a period of 30 minutes. Concomitant to 177Lu-DOTATATE, patients will receive IV fluids and an IV infusion of amino acid solution for renal protection23. Patients will receive four infusions every 8 weeks (maximum cumulative radioactivity, 29.6 GBq \[800 mCi\]). Olaparib will be administered PO, BID, days 2-29, every 8 weeks at a fixed dose of 187.5mg/m2 twice daily (BID).

Sponsors & Collaborators

  • Fundación de investigación HM

    lead OTHER

Principal Investigators

  • Marta Osuna Marco, PhD · HM Monteprincipe

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-20
Primary Completion
2029-07-31
Completion
2029-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06607692 on ClinicalTrials.gov