PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours
Trial Parameters
Brief Summary
This phase 1 dose-escalation study is designed to evaluate the safety and tolerability of talazoparib in combination with 177Lu-DOTA-Octreotate peptide receptor radionuclide therapy (PRRT) in patients with metastatic pancreatic or midgut neuroendocrine tumour (NET).
Eligibility Criteria
Inclusion Criteria: 1. Patient must be \> or equal to18 years of age and must have provided written informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 3. Histologically confirmed Grade 2 NET, Ki-67 of 3-20%, from pancreatic or intestinal origin. 4. Patient clinically suitable for PRRT 5. Tumor SSR uptake on GaTate PET/CT higher than liver activity, ≥ modified Krenning 3 score 6. No discordant FDG-avid disease on FDG PET/CT 7. No evidence of significant uncorrected carcinoid heart disease 8. Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled assessments 9. Patients must have adequate bone marrow, hepatic and renal function defined as: * Haemoglobin ≥100 g/L * Absolute neutrophil count ≥1.5x109/L * Platelets ≥150 x109/L * Total bilirubin ≤1.5 x upper limit of normal (ULN) * Aspartate transaminase (AST) (SGOT) and alanine transaminase (ALT) (SGPT) ≤2.5 x ULN if there is