Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05053854

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

Led by Peter MacCallum Cancer Centre, Australia · Updated on 2025-02-20

24

Participants Needed

1

Research Sites

394 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient must be 18 years of age or older and have provided written informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Histologically confirmed Grade 2 neuroendocrine tumor (NET) with Ki-67 of 3-20%, originating from the pancreas or intestines
  • Clinically suitable for peptide receptor radionuclide therapy (PRRT)
  • Tumor somatostatin receptor uptake on GaTate PET/CT higher than liver activity, with a modified Krenning score of 3 or more
  • No discordant FDG-avid disease on FDG PET/CT
  • No significant uncorrected carcinoid heart disease
  • Willing and able to comply with the study protocol including treatments and assessments
  • Adequate bone marrow, liver, and kidney function as defined by hemoglobin of 100 g/L or higher, absolute neutrophil count of 1.5x10^9/L or higher, platelets of 150x10^9/L or higher, total bilirubin 1.5 times upper limit of normal (ULN) or less, AST and ALT up to 2.5 times ULN without liver metastasis or up to 5 times ULN with liver metastases, albumin 30 g/L or higher, and estimated glomerular filtration rate (eGFR) of 50 ml/min or higher
Not Eligible

You will not qualify if you...

  • Surgery or radiotherapy within 3 weeks before registration; must have recovered from major surgery effects
  • Prior exposure to peptide receptor radionuclide therapy (177Lu, 111In, or 90Y labeled), PARP inhibitors, or immunotherapy
  • Uncontrolled illnesses likely to interfere with participation or compliance
  • Other cancers unless cured with no evidence of disease within the last 3 years, except treated non-melanoma skin cancer or melanoma in situ
  • History of myelodysplastic syndrome or acute myeloid leukemia
  • Difficulty swallowing oral medications or gastrointestinal disorders affecting drug absorption
  • Use of strong P-gp inhibitors, P-gp inducers, or BCRP inhibitors should be avoided
  • Participation in another clinical trial with an investigational product or systemic therapy within the past 3 weeks (except short-acting somatostatin analogues)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

Actively Recruiting

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Research Team

G

Grace Kong

CONTACT

R

Research Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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