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).
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).
2 other identifiers
interventional
25
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2024
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2024
CompletedStudy Start
First participant enrolled
September 20, 2024
CompletedFirst Posted
Study publicly available on registry
September 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
April 14, 2026
April 1, 2026
4.8 years
September 4, 2024
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To estimate the safety of the combination of 177LUDOTATATE and olaparib.
Measured by incidence of DLTs; finding of MTD and RP2D
Through first cycle, an average of 8 weeks
To estimate the preliminary activity of the combination of 177LUDOTATATE and olaparib.
ORR
From enrollment to the end of treatment, up to 24 months
Secondary Outcomes (3)
To test the activity of the combination of 177LUDOTATATE and olaparib
Through study completion, up to 24 months
To test the safety of the combination of 177LUDOTATATE and olaparib
Through study completion, up to 24 months
To test the tolerability of the combination of 177LUDOTATATE and olaparib
Through study completion, up to 24 months
Study Arms (1)
Lu-DOTATATE (Lutathera® ) and olaparib
EXPERIMENTALLu-DOTATATE (Lutathera®) and olaparib for a maximum of 4 cycles unless unacceptable toxic effects occur, there is centrally confirmed disease progression (according to RECIST v1.1/RAPNO/INRC) on imaging, the patient is unable or unwilling to adhere to trial procedures, the patient withdraws consent, or the patient dies. 177Lu-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. Olaparib will be administered PO, BID, days 3-28, every 8 weeks. Dose escalation of olaparib with the classic 3+3 design: DL1 62.5 mg/m2 (max 100 mg); DL2 93.5 mg/m2 (max 150 mg); DL3 125 mg/m2 (max 200 mg).
Interventions
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).
Eligibility Criteria
You may qualify if:
- months - 18 years of age at the time of the initial diagnosis.
- 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.
- The evaluation of SSTR expression will be classified according to a qualitative 4-point scale: SSTR expression V (visual score):
- Score = 0: Below or equal to blood pool
- Score = 1: Above blood pool and lower than liver
- Score = 2: Equal to or above liver and lower than spleen
- Score = 3: Equal to or above spleen
- Patients with scores ≥ 2 in the majority of the tumoral lesions will be considered to have a positive SSTR-PET and will be therefore eligible for the trial. Patients with a higher score are presumed to have a better response to the treatment.
- It is admissible to have non-measurable disease only (e.g., HR-NB with bone-only or bone-marrow-only active disease).
- Performance status ≥ 50% according to Lansky scale (\<16 years old) or Karnofsky scale (for ≥16 years old).
- Life expectancy of at least 3 months.
- Availability of ability to swallow tablets or capsules.
- Adequate organ function within 28 days prior to enrolment, as defined by:
- Hb ≥10 g/dl (packed red blood transfusion is acceptable up to 24 hours prior starting treatment);
- White blood cell (WBC) count ≥ 2500/μL (equivalent to 2.5 x 109/L)
- +11 more criteria
You may not qualify if:
- 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.
- Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE.
- Known hypersensitivity to any of the excipients.
- Subjects who have an uncontrolled infection.
- Lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HM Monteprincipe
Boadilla del Monte, Madrid, 28660, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marta Osuna Marco, PhD
HM Monteprincipe
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2024
First Posted
September 23, 2024
Study Start
September 20, 2024
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
April 14, 2026
Record last verified: 2026-04