Health Trials

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).

ConditionsSolid Tumor CancerMedulloblastomaHigh Risk NeuroblastomaHigh Grade GliomasMeningiomaParagangliomaPheochromocytomaNeuroendocrine Tumours (NET)Adrenal TumoursDIPGGlioblastomaGlioblastoma (GBM)Osteosarcoma RecurrentCarcinoma AdrenalSynovial SarcomasEsthesioneuroblastomaNeuroblastoma RecurrentSolid Tumor Refractory to Conventional TreatmentMedulloblastoma RecurrentParaganglioma/ PhaeochromocytomaEpendymomaEpendymoma Recurrent
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age3+
SponsorFundación de investigación HM

About this trial

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 criteria

Qualifiers

18 months - 18 years of age at the time of the initial diagnosis.

≥ 3 years at the moment of inclusion in the trial.

Diagnosis: relapsed/refractory solid tumours with positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study.

Score = 0: Below or equal to blood pool

Disqualifiers

Previous significant drug-induced hepatitis toxicity experienced in the past that has required treatment dose reductions, treatment discontinuation or that, at the investigator discretion, could infer a risk.

Having received more than one previous treatment with other radiolabelled somatostatin analogues.

Inability to swallow tablets or capsules.

Subjects who are currently receiving any other anticancer and/or investigational agents (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]). There must be at least 28 days of washout from any prior treatment. In case of checkpoints inhibitors, there should be at least 4 months of washout. Palliative Radiation Therapy for symptom control (e.g. pain relief) could be acceptable, at the discretion of the investigator.

Trial design

Treatments tested in this trial

  • Olaparib; 177Lu-DOTATATE

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators

Fundación de investigación HM

Lead sponsor

Source ClinicalTrials.gov