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
| Condition(s) | Neuroendocrine Tumors, Peptide Receptor Radionuclide Therapy |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 coun |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Erasmus Medical Center |
| Locations | Rotterdam, South Holland, Netherlands |
| Start date | 2022-06-01 |
| NCT ID | NCT05870423 |
| Official listing | https://clinicaltrials.gov/study/NCT05870423 |