Combining olaparib with PRRT for advanced gastroenteropancreatic neuroendocrine tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1 dose-escalation trial designed to find the maximum tolerated dose of olaparib when given alongside salvage 177Lu‑DOTATATE PRRT. Eligible participants have well-differentiated (grade 1–3) gastroenteropancreatic NETs with progression after prior PRRT, measurable disease, and confirmed somatostatin receptor uptake. Secondary aims include preliminary measures of tumor response, pharmacokinetics of olaparib, and biomarker changes. Treatment and follow-up are conducted at Erasmus MC in Rotterdam.

Why it matters

Who can join: the full rules

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.

Where it's running

• Erasmus MC
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: M.N. Becx
• Email: m.becx@erasmusmc.nl
• Phone: 43449

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.