NCT05870423 Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors
| NCT ID | NCT05870423 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Erasmus Medical Center |
| Condition | Neuroendocrine Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2022-06-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05870423 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuroendocrine Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05870423 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05870423 currently recruiting?
Yes, NCT05870423 is actively recruiting participants. Contact the research team at m.becx@erasmusmc.nl for enrollment information.
Where is the NCT05870423 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT05870423 clinical trial?
NCT05870423 is sponsored by Erasmus Medical Center. The trial plans to enroll 24 participants.