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 range3 Years
SexALL
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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;
…
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