RecruitingPhase 1Phase 2NCT06607692

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).

Single-arm Open-label Phase I/II 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).


Sponsor

Fundación de investigación HM

Enrollment

25 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 3 Years

Plain Language Summary

Simplified for easier understanding

This study (called LuPARPed) tests a combination of a targeted radiation therapy called 177Lu-DOTATATE (Lutathera) with a drug called olaparib (a PARP inhibitor) in children and teenagers with solid tumors that have come back or are not responding to treatment. The tumors must have a specific protein on their surface (somatostatin receptors) that the Lutathera drug can target. **You may be eligible if...** - Your child is between 3 and 18 years old at the time of enrollment (and was at least 18 months old at initial diagnosis) - They have a relapsed or treatment-resistant solid tumor - The tumor shows uptake on a special scan (SSTR-PET), confirming the presence of the target protein - The SSTR-PET scan was done within the past 3 months **You may NOT be eligible if...** - The tumor does not show active uptake on the SSTR-PET scan - The child is under 3 years old at the time of enrollment - Other medical conditions make the treatment combination unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlaparib; 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).


Locations(1)

HM Monteprincipe

Boadilla del Monte, Madrid, Spain

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NCT06607692


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