Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05870423

Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors

Led by Erasmus Medical Center · Updated on 2025-06-05

24

Participants Needed

1

Research Sites

239 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically proven locally advanced or metastatic, well-differentiated (grade 1, 2 or 3) neuroendocrine tumor (NET).
  • Disease progression based on RECIST v1.1 after initial or salvage PRRT with 177Lu-DOTATATE, with at least 12 months progression-free interval since first PRRT cycle or no suitable systemic treatment options.
  • Eligible for two cycles of salvage PRRT.
  • Measurable disease on CT or MRI according to RECIST v1.1.
  • Confirmed presence of somatostatin receptors on all target lesions by positive uptake on 68Ga-DOTATATE/-TOC/-NOC PET-CT/MRI scan.
  • Age 18 years or older.
  • Karnofsky Performance Score greater than 60.
Not Eligible

You will not qualify if you...

  • Hemoglobin concentration below 6.2 mmol/L; white blood cell count below 3 x 10^9/L; platelet count below 100 x 10^9/L; neutrophil count below 1.5 x 10^9/L.
  • Renal insufficiency with creatinine clearance under 50 mL/min measured by 24-hour urine collection.
  • Liver abnormalities: total bilirubin above 3 times upper limit of normal (ULN), ALT or AST above 2.5 times ULN, or serum albumin below 3.0 g/dL unless normal prothrombin time.
  • Pregnancy, breastfeeding, or inability to use effective contraception for females of child-bearing age.
  • Neuroendocrine carcinoma of any origin.
  • Surgery, radioembolization, chemoembolization, chemotherapy, or radiofrequency ablation within 12 weeks prior to study.
  • Interferons, everolimus, sunitinib, or other systemic therapies within 4 weeks before study.
  • Uncontrolled congestive heart failure (NYHA class II, III, IV).
  • Other significant uncontrolled medical, psychiatric, or surgical conditions that may interfere with study completion.
  • Prior external beam radiation therapy to more than 25% of bone marrow.
  • Other known cancers except non-melanoma skin cancer and cervical carcinoma in situ unless treated and recurrence-free for 5 years.
  • Use of strong CYP3A4 inhibitors within 1 week or CYP3A4 inducers within 4 weeks before treatment.
  • Any other clinically significant disorder or condition that poses safety risks or interferes with study evaluation.
  • Known allergy or intolerance to study drugs.
  • Inability to provide informed consent.
  • Receiving end of life care.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Erasmus MC

Rotterdam, South Holland, Netherlands, 3000CA

Actively Recruiting

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Research Team

M

M.N. Becx

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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