Actively Recruiting
Single-arm Open-label Phase I/II Study of 177Lu-DOTATATE (Lutathera4) Combined With PARP Inhibitor Olaparib for Recurrent or Relapsed Solid Tumors Expressing Somatostatin Receptors in Children and Adolescents
Led by Fundación de investigación HM · Updated on 2026-06-04
25
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of 177Lu-DOTATATE (Lutathera4) and the PARP inhibitor olaparib for treating children and adolescents with recurrent or relapsed solid tumors that express somatostatin receptors (SSTR). These tumors typically have a poor prognosis, and while 177Lu-DOTATATE has been approved for certain adult neuroendocrine tumors, its use in children is still being explored. Combining 177Lu-DOTATATE with olaparib aims to enhance the treatment effect by preventing DNA repair in cancer cells, potentially leading to increased tumor cell death. The study is a single-arm, open-label Phase I/II trial administering up to four cycles of treatment. 177Lu-DOTATATE is given intravenously every 8 weeks at doses adjusted by age and body weight, along with intravenous fluids and amino acid infusions to protect the kidneys. Olaparib is taken orally twice daily from day 3 to day 28 of each 8-week cycle, with doses gradually increased according to a standard design. Treatment continues unless unacceptable side effects, disease progression, withdrawal, or death occur. Participants will undergo regular assessments including imaging to monitor tumor response, safety evaluations, and tests of organ function. Researchers will measure safety mainly through observations during the first 8 weeks and evaluate preliminary treatment activity up to 24 months. The study includes follow-up to assess longer-term safety, tolerability, and effectiveness of the drug combination in this young population.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Age between 18 months and 18 years at initial diagnosis
- At least 3 years old at trial inclusion
- Diagnosis of relapsed or refractory solid tumors with positive somatostatin receptor uptake on SSTR-PET within 3 months before study entry
- SSTR expression score of 2 or higher on the majority of tumor lesions
- Performance status 50% or higher on Lansky scale (<16 years) or Karnofsky scale (≥16 years)
- Life expectancy of at least 3 months
- Ability to swallow tablets or capsules
- Adequate organ function within 28 days prior to enrollment, including hemoglobin ≥10 g/dl, white blood cell count ≥2500/µL, absolute neutrophil count ≥1000/µL, platelets ≥100,000/µL without recent transfusion, creatinine ≤1.5 x upper limit of normal or eGFR ≥60 mL/min/1.73m2, total bilirubin ≤1.5 x ULN (≤3.0 ULN if Gilbert's Syndrome), ALT/AST ≤3.0 ULN, and albumin >3.0 g/dL
- Negative pregnancy test for females with menses onset or age ≥12 years
- Agreement to use effective contraception during the study and for specified periods after last dose
- Ability and willingness to provide informed consent (parent or guardian consent for those <18 years, assent for ages 12-17)
- Adequate recovery from major surgery prior to treatment
- No conditions interfering with study compliance or follow-up
You will not qualify if you...
- History of significant drug-induced hepatitis requiring dose reduction or discontinuation
- More than one previous treatment with other radiolabeled somatostatin analogues
- Inability to swallow tablets or capsules
- Currently receiving other anticancer or investigational treatments without required washout periods
- Treatment with long-acting somatostatin analogues within 28 days prior to study drug administration
- Known allergy to any study drug components
- Uncontrolled infections
- Lactating females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 32 weeks (four 8-week cycles)
Participants receive up to four cycles of 177Lu-DOTATATE administered intravenously on Day 1 every 8 weeks, combined with oral olaparib taken twice daily from Day 2 to Day 29 of each cycle.
4 visits every 8 weeks for infusions; olaparib taken daily between visits
Trial Site Locations
Total: 1 location
1
HM Monteprincipe
Boadilla del Monte, Madrid, Spain, 28660
Actively Recruiting
Research Team
M
Marta Osuna Marco MD, Medical Degree
S
START Pediatrics
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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