neuroendocrine tumors
Conditions
Interventions
2x18 days taking tablets of olaparib, 2 biopsies of the tumor, 29 additional
venipunctures, 7 ECG*s, 4 additional SPECT/CT scans.
Sponsors
Moleculaire geneeskunde
Eligibility
Age
18 Years to 99 Years
Inclusion 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
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Hb concentration 3 x ULN, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x ULN or serum albumin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose (MTD) of olaparib in combination with PRRT in patients with a well-differentiated advanced NET, progressive after treatment with PRRT. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy, pharmacokinetics (PK) and biomarker response of olaparib in combination with PRRT in patients with a well-differentiated advanced NET, progressive after treatment with PRRT. | — |
Countries
Netherlands
Outcome results
None listed