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Clinical Trials in the Netherlands / NCT05870423
Recruiting Phase 1

Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors

NCT05870423 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 1
Started
2022-06-01
Last updated
2025-06-05

Condition(s) studied

Neuroendocrine TumorsPeptide Receptor Radionuclide Therapy

Investigational drug(s) / intervention(s)

olaparib →

olaparib: 18 days olaparib during each cycle of PRRT

Study summary

This is a phase 1 dose-escalation study to determine the maximum tolerated dose of the PARP inhibitor olaparib in combination with PRRT in patients with a well-differentiated advanced gastroenteropancreatic NET (GEP NET), progressive after PRRT. As secondary objectives, efficacy, pharmacokinetics and biomarker response will be investigated.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Histologically proven locally advanced or metastatic, well-differentiated (grade 1, 2 or 3) NET. * Disease progression based on RECIST v1.1 following initial or salvage treatment with PRRT with 177Lu-DOTATATE with a progression free interval of at least 12 months since first cycle of previous administration of PRRT or with no suitable systemic alternative treatment options. * The patient is eligible for two cycles of salvage PRRT. * Measurable disease according to RECIST v1.1 on CT/MRI. * Confirmed presence of somatostatin receptors on all target lesions on CT/MRI, based on positive uptake on a 68Ga-DOTATATE/-TOC/-NOC PET-CT/MRI scan. * Age ≥ 18 years. * Karnofsky Performance Score (KPS) \> 60. Exclusion Criteria: * Hb concentration \<6.2 mmol/L; white blood cell count \<3x109/L; platelets \<100x109/L; neutrophil count \<1.5x109/L. * Renal insufficiency defined as a creatinine clearance \<50 mL/min, measured in 24-hour urine collection. * Liver function or enzyme abnormalities defined as a total bilirubin \>3 x ULN, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 x ULN or serum albumin \<3.0 g/dL unless prothrombin time is within the normal range. * Pregnancy, lactation and inability to comply with effective means of contraception in females of child-bearing age. * Neuroendocrine carcinoma of any origin. * Any surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation within 12 weeks prior to inclusion in the study. Interferons, everolimus, sunitinib or other systemic therapies within 4 weeks prior to inclusion in the study. * Uncontrolled congestive heart failure (NYHA II, III, IV). * Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with the completion of the study. * Prior external beam radiation therapy to more than 25% of the bone marrow. * Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years. * Patients who use a strong CYP3A4 inhibitor within 1 week before start of the treatment or a CYP3A4 inducer within 4 weeks before start of the treatment. * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. * Known allergy or intolerance for the (non-)investigational drugs. * Inability to provide informed consent. * End of life care.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Erasmus MC Rotterdam South Holland Recruiting

On this site

📄 Lynparza (olaparib) drug profile →

More Erasmus Medical Center trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05870423 on ClinicalTrials.gov ↗ ← All trials in the Netherlands