NCT05053854 PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours
| NCT ID | NCT05053854 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Peter MacCallum Cancer Centre, Australia |
| Condition | Neuroendocrine Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2021-12-08 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2021-12-08 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria: 1. Surgery or radiotherapy within \<3 weeks of registration. Patients must have recovered from any effects of any major surgery. 2. Any prior exposure to peptide receptor radionuclide therapy (177Lu, 111In or 90Y labelled), PARPi, immunotherapy 3. Uncontrolled intercurrent illness that is likely to impede participation and /or compliance 4. 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. 5. Previous or current history of myelodysplastic syndrome/acute myeloid leukemia 6. Patients unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with the absorption of the study medication. 7. 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. 8. Participation in another clinical study with an investigational product or another systemic therapy administered in the last 3 weeks (except short acting SSA).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05053854 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuroendocrine Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05053854 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05053854 currently recruiting?
Yes, NCT05053854 is actively recruiting participants. Contact the research team at NMResearch@petermac.org for enrollment information.
Where is the NCT05053854 trial being conducted?
This trial is being conducted at Melbourne, Australia.
Who is sponsoring the NCT05053854 clinical trial?
NCT05053854 is sponsored by Peter MacCallum Cancer Centre, Australia. The trial plans to enroll 24 participants.