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New treatment option for Solid Tumor Cancer
Official title 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).
ClinicalTrials.gov ID: NCT06607692
What this study is testing
What is Olaparib; 177Lu-DOTATATE?
Olaparib; 177Lu-DOTATATE is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for solid tumor cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 and older
You may be able to join if
- 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...
- Score = 0: Below or equal to blood pool
- Score = 1: Above blood pool and lower than liver
You likely can't join if
- Previous significant drug-induced hepatitis toxicity experienced in the past that has required treatment dose reductions, treatment discontinuation...
- Having received more than one previous treatment with other radiolabelled somatostatin analogues.
- Inability to swallow tablets or capsules.
- people who are currently receiving any other anticancer and/or investigational agents (e.g. chemotherapy, immunotherapy or biological therapy...
- Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE.
- Known hypersensitivity to any of the excipients.
See the full eligibility 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...
- 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...
- 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;
- Platelets ≥ 100.000/μl, without transfusion in the prior ≥7 days;
- Serum plasma creatinine ≤ 1.5 x upper limit of normal (ULN) OR estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2 (assessed by 2009-Schwartz formula).
- Total bilirubin ≤ 1.5 x the institutional ULN. For patients with known Gilbert's Syndrome ≤ 3.0 ULN is permitted.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 ULN.
- Albumin \>3.0 g/dL (3.0 g/dL is equivalent to 30 g/L)
- A negative serum or urine pregnancy test in women with onset of menses or ≥12 years of age.
- Patients of reproductive potential must agree to use highly effective contraceptive methods for the entire study duration and up to 7 months, in case of females, and 4 months in case of males, after the last dose of...
- Have the ability to comprehend and willingness to provide written informed consent (ICF) for the study before patient registration or any trial-related screening procedures. If the patient is \<18 years old, the written...
- Adequate recovery from major surgery prior to receiving study treatment.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient...
- 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.
- people 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...
- Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE.
- Known hypersensitivity to any of the excipients.
- people who have an uncontrolled infection.
- Lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Boadilla del Monte, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boadilla del Monte, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.