Actively Recruiting

Phase 1
Phase 2
Age: 3Years +
All Genders
NCT06607692

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).

Led by Fundación de investigación HM · Updated on 2026-04-14

25

Participants Needed

1

Research Sites

271 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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).

Who Can Participate

Age: 3Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 months and 18 years at initial diagnosis
  • At least 3 years old at time of enrollment
  • Diagnosis of relapsed or refractory solid tumors with positive somatostatin receptor expression on PET scan within 3 months
  • Somatostatin receptor expression score of 2 or higher in most tumor lesions
  • Performance status of 50% or higher on Lansky or Karnofsky scale
  • Life expectancy of at least 3 months
  • Ability to swallow tablets or capsules
  • Adequate organ function within 28 days prior to enrollment including specified blood counts and liver and kidney function
  • Negative pregnancy test for females with menses or aged 12 years and older
  • Agreement to use effective contraception during and after the study as specified
  • Ability and willingness to provide informed consent (parent/guardian consent and assent for minors)
  • Adequate recovery from major surgery before treatment
  • No psychological, familial, social, or geographical issues that would interfere with study compliance
Not Eligible

You will not qualify if you...

  • History of significant drug-induced hepatitis requiring dose reduction or treatment discontinuation
  • More than one prior treatment with radiolabelled somatostatin analogues
  • Inability to swallow tablets or capsules
  • Currently receiving other anticancer or investigational treatments without appropriate washout period
  • Treatment with long-acting somatostatin analogues within 28 days prior to 177Lu-DOTATATE
  • Known allergy to any study drug ingredients
  • Uncontrolled infection
  • Lactating women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

HM Monteprincipe

Boadilla del Monte, Madrid, Spain, 28660

Actively Recruiting

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Research Team

M

Marta Osuna Marco MD, Medical Degree

CONTACT

S

START Pediatrics

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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