Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor… (NCT06607692) | Clinical Trial Compass
RecruitingPhase 1/2
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).
Spain25 participantsStarted 2024-09-20
Plain-language 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)
Who can participate
Age range
3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* 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.
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)
* Absolute Neutrophil Count (ANC) ≥ 1000/μl;
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To estimate the safety of the combination of 177LUDOTATATE and olaparib.
Timeframe: Through first cycle, an average of 8 weeks
2
To estimate the preliminary activity of the combination of 177LUDOTATATE and olaparib.
Timeframe: From enrollment to the end of treatment, up to 24 months