PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours
Phase 1 Trial of PARP Inhibitor Combined With 177Lu-DOTA-Octreotate Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Metastatic NeuroEndocrine Tumor
Peter MacCallum Cancer Centre, Australia
24 participants
Dec 8, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria17
- 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 Criteria8
- 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.
- Previous or current history of myelodysplastic syndrome/acute myeloid leukemia
- Patients unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with the absorption of the study medication.
- 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).
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Interventions
During dose escalation, doses of talazoparib that can be administered are 0.1mg, 0.25mg, 0.5mg or 1mg oral daily. Talazoparib will be given on days 2-6 of each cycle of 177Lu-DOTA-Octreotate for cycles 2-4, every 8 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05053854