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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Olaparib; 177Lu-DOTATATE

    Drug

    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).

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Lu-DOTATATE (Lutathera® ) and olaparibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To estimate the safety of the combination of 177LUDOTATATE and olaparib.

Measured by incidence of DLTs; finding of MTD and RP2D

Time frame
Through first cycle, an average of 8 weeks
2

To estimate the preliminary activity of the combination of 177LUDOTATATE and olaparib.

ORR

Time frame
From enrollment to the end of treatment, up to 24 months

Secondary outcomes

1

To test the activity of the combination of 177LUDOTATATE and olaparib

DCR, DOR, TTR, PFS, OS, quality of life assessment

Time frame
Through study completion, up to 24 months
2

To test the safety of the combination of 177LUDOTATATE and olaparib

AEs, SAEs

Time frame
Through study completion, up to 24 months
3

To test the tolerability of the combination of 177LUDOTATATE and olaparib

Frequency of treatment reductions, need of drug holidays and delays on treatment administration

Time frame
Through study completion, up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación de investigación HM

Lead sponsor

Source ClinicalTrials.gov
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