PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeter MacCallum Cancer Centre, Australia

About this trial

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

Qualifiers

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

Disqualifiers

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

Uncontrolled intercurrent illness that is likely to impede participation and /or compliance

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.

Trial design

Treatments tested in this trial

  • Talazoparib

Treatment groups

24 Participants
are divided into 1 treatment group