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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    24
  • sponsor
    Peter MacCallum Cancer Centre, Australia
Updated on 4 October 2022

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).

Description

This phase 1, single arm, single centre study is designed to evaluate the safety and tolerability of talazoparib in combination with 177Lu-DOTA-Octreotate in patients with metastatic NET.

Patients will receive 1 cycle of 177Lu-DOTA-Octreotate alone followed by 3 cycles of 177Lu-DOTA-Octreotate combined with 5 days of talazoparib.

Details
Condition Neuroendocrine Tumors
Treatment Talazoparib
Clinical Study IdentifierNCT05053854
SponsorPeter MacCallum Cancer Centre, Australia
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 midgut origin
Must have progressed on at least one line of prior therapy, which can include somatostatin analogues
Progressive disease on imaging (CT/MRI or GaTate PET/CT), or evidence of uncontrolled hormone-secretory symptoms despite conventional treatment
Tumor SSR uptake on GaTate PET/CT higher than liver activity, ≥ modified Krenning 3 score
No discordant FDG-avid disease on 18F-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 ≥ 60 ml/min

Exclusion Criteria

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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