Tests talazoparib with radioactive therapy for neuroendocrine tumours
Tests talazoparib plus radioactive therapy in adults with spreading pancreatic or midgut neuroendocrine tumours.
Plain-language title generated from the registry record
Registry title: PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours
Key facts
- Where
- Melbourne, AustraliaSee the site
- Phase
- Phase 1
Where in Australia
- Peter MacCallum Cancer CentreMelbourne, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peter MacCallum Cancer Centre, Australia
- Trial code
- NCT05053854
- Record updated
- 20 February 2025
- Original description
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).Read full original descriptionShow less
Phase 1 Trial of PARP Inhibitor Combined With 177Lu-DOTA-Octreotate Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Metastatic NeuroEndocrine Tumor
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).
Inclusion: Patient must be > or equal to18 years of age and must have provided written informed consent; Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2; Histologically confirmed Grade 2 NET, Ki-67 of 3-20%, from pancreatic or intestinal origin; Patient clinically suitable for PRRT; Tumor SSR uptake on GaTate PET/CT higher than liver activity, ≥ modified Krenning 3 score; No discordant FDG-avid disease on FDG PET/CT; No evidence of significant uncorrected carcinoid heart disease; Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled assessments; 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 no evidence of liver metastasis or ≤5 x ULN in the presence of liver metastases; Albumin ≥ 30 g/L; Adequate renal function: eGFR ≥ 50 ml/min.
Exclusion: Surgery or radiotherapy within <3 weeks of registration. Patients must have recovered from any effects of any major surgery; Any prior exposure to peptide receptor radionuclide therapy (177Lu, 111In or 90Y labelled), PARPi, immunotherapy; Other malignancies unless curatively treated with no evidence of disease within previous 3-years other than adequately treated non-melanoma skin cancer or melanoma in situ; Previous or current history of myelodysplastic syndrome/acute myeloid leukemia; Use of strong P-gp inhibitors (eg, dronedarone, quinidine, ranolazine, verapamil, ketoconazole, itraconazole), P-gp inducers (eg, rifampin, tipranavir/ritonavir), or BCRP inhibitors (eg, elacridar [GF120918]) should be avoided; Participation in another clinical study with an investigational product or another systemic therapy administered in the last 3 weeks (except short acting SSA); Uncontrolled intercurrent illness that is likely to impede participation and /or compliance; Patients unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with the absorption of the study medication.