Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors
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.
• 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.