Cancer Help Guide

Adrenocortical carcinoma · NCT06607692

LUPARPED: 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).

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).

Status
RECRUITING (ClinicalTrials.gov)
Phase
PHASE1, PHASE2
Sponsor
Fundación de investigación HM
Registry records
CTGOV NCT06607692 (RECRUITING)
Registry last updated 2026-06-04

Eligibility, line by line

VerdictIn plain words (machine summary)Registry text, verbatimIf unmet
inclusion
inclusion · age sex · confidence 0.90
18 months - 18 years of age at the time of the initial diagnosis."18 months - 18 years of age at the time of the initial diagnosis."
inclusion
inclusion · age sex · confidence 0.95
≥ 3 years at the moment of inclusion in the trial."≥ 3 years at the moment of inclusion in the trial."
inclusion
inclusion · condition · confidence 0.95
Diagnosis: relapsed/refractory solid tumours"relapsed/refractory solid tumours"
inclusion
inclusion · biomarker · confidence 0.95
Positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study."positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study"
inclusion
inclusion · biomarker · confidence 0.90
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 scores ≥ 2 in the majority of the tumoral lesions will be considered to have a positive SSTR-PET"
inclusion
inclusion · lesion burden · confidence 0.30
It is admissible to have non-measurable disease only (e.g., HR-NB with bone-only or bone-marrow-only active disease)."It is admissible to have non-measurable disease only (e.g., HR-NB with bone-only or bone-marrow-only active disease)."
inclusion
inclusion · performance status · confidence 0.30
Performance status ≥ 50% according to Lansky scale (<16 years old) or Karnofsky scale (for ≥16 years old)."Performance status ≥ 50% according to Lansky scale (\<16 years old) or Karnofsky scale (for ≥16 years old)."
inclusion
inclusion · life expectancy · confidence 0.95
Life expectancy of at least 3 months."Life expectancy of at least 3 months."
inclusion
inclusion · other · confidence 0.30
Availability of ability to swallow tablets or capsules."Availability of ability to swallow tablets or capsules."
inclusion
inclusion · lab value · confidence 0.95
Hb ≥10 g/dl (packed red blood transfusion is acceptable up to 24 hours prior starting treatment)"Hb ≥10 g/dl"
inclusion
inclusion · lab value · confidence 0.95
White blood cell (WBC) count ≥ 2500/μL (equivalent to 2.5 x 109/L)"White blood cell (WBC) count ≥ 2500/μL"
inclusion
inclusion · lab value · confidence 0.95
Absolute Neutrophil Count (ANC) ≥ 1000/μl"Absolute Neutrophil Count (ANC) ≥ 1000/μl"
inclusion
inclusion · lab value · confidence 0.95
Platelets ≥ 100.000/μl, without transfusion in the prior ≥7 days"Platelets ≥ 100.000/μl"
inclusion
inclusion · lab value · confidence 0.90
Serum plasma creatinine ≤ 1.5 x upper limit of normal (ULN)"Serum plasma creatinine ≤ 1.5 x upper limit of normal (ULN)"
inclusion
inclusion · lab value · confidence 0.90
estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2 (assessed by 2009-Schwartz formula)"estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2"
inclusion
inclusion · lab value · confidence 0.95
Total bilirubin ≤ 1.5 x the institutional ULN."Total bilirubin ≤ 1.5 x the institutional ULN"
inclusion
inclusion · lab value · confidence 0.85
For patients with known Gilbert's Syndrome ≤ 3.0 ULN is permitted."For patients with known Gilbert's Syndrome ≤ 3.0 ULN is permitted"
inclusion
inclusion · lab value · confidence 0.90
Alanine aminotransferase (ALT) ≤ 3.0 ULN."Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 ULN"
inclusion
inclusion · lab value · confidence 0.90
Aspartate aminotransferase (AST) ≤ 3.0 ULN."Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 ULN"
inclusion
inclusion · lab value · confidence 0.95
Albumin >3.0 g/dL (3.0 g/dL is equivalent to 30 g/L)"Albumin \>3.0 g/dL"
inclusion
inclusion · pregnancy contraception · confidence 0.30
A negative serum or urine pregnancy test in women with onset of menses or ≥12 years of age."A negative serum or urine pregnancy test in women with onset of menses or ≥12 years of age."
inclusion
inclusion · pregnancy contraception · confidence 0.30
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 Lutathera, or up to 6 months, in case of females, and 3 months in case of males, after the last dose of olaparib, whichever takes places later."Patients of reproductive potential must agree to use highly effective contraceptive methods for the entire study duration"
inclusion
inclusion · consent · confidence 0.30
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 informed consent must be signed by the parent(s) or legal guardian(s) according to national regulations."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."
inclusion
inclusion · consent · confidence 0.30
In the case of patients between 12 and 17 years, they must sign an assent form, and if the patient turns 18 during their participation in the study, they must sign an informed consent form."In the case of patients between 12 and 17 years, they must sign an assent form"
inclusion
inclusion · prior therapy · confidence 0.30
Adequate recovery from major surgery prior to receiving study treatment."Adequate recovery from major surgery prior to receiving study treatment."
inclusion
inclusion · logistics · confidence 0.30
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 before registration in the trial."Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule"
exclusion
exclusion · comorbidity · confidence 0.90
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."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."
exclusion
exclusion · prior therapy · confidence 0.30
Having received more than one previous treatment with other radiolabelled somatostatin analogues."Having received more than one previous treatment with other radiolabelled somatostatin analogues."
exclusion
exclusion · other · confidence 0.30
Inability to swallow tablets or capsules."Inability to swallow tablets or capsules."
exclusion
exclusion · prior therapy · confidence 0.90
Subjects who are currently receiving any other anticancer and/or investigational agents (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies])."Subjects who are currently receiving any other anticancer and/or investigational agents"
exclusion
exclusion · washout · confidence 0.30
There must be at least 28 days of washout from any prior treatment."There must be at least 28 days of washout from any prior treatment."
exclusion
exclusion · washout · confidence 0.30
In case of checkpoints inhibitors, there should be at least 4 months of washout."In case of checkpoints inhibitors, there should be at least 4 months of washout."
exclusion
exclusion · washout · confidence 0.90
Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE."Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE."
exclusion
exclusion · comorbidity · confidence 0.90
Known hypersensitivity to any of the excipients."Known hypersensitivity to any of the excipients."
exclusion
exclusion · comorbidity · confidence 0.95
Subjects who have an uncontrolled infection."Subjects who have an uncontrolled infection."
exclusion
exclusion · pregnancy contraception · confidence 0.90
Lactating women."Lactating women."

Criteria extracted by claude-sonnet-5-5; 0 extracted quotes rejected for not matching the registry text.

Full eligibility text as the registry publishes it
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;
  * 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 Lutathera, or up to 6 months, in case of females, and 3 months in case of males, after the last dose of olaparib, whichever takes places later.
* 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 informed consent must be signed by the parent(s) or legal guardian(s) according to national regulations. In the case of patients between 12 and 17 years, they must sign an assent form, and if the patient turns 18 during their participation in the study, they must sign an informed consent form.
* 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 before registration in the trial.

Exclusion criteria

* 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.

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