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RecruitingLast updated: 9 January 2024

PARLuNET: This phase I trial is evaluating how safe and tolerable a targeted therapy (talazoparib) is in combination with radionuclide therapy (177Lu-DOTA-Octreotate) in people with metastatic pancreatic neuroendocrine cancerPhase 1 Trial of PARP Inhibitor Combined With 177Lu-DOTA-Octreotate Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Metastatic NeuroEndocrine Tumor

Clinical summary

Summary

All eligible participants will receive 4 cycles of 177Lu-DOTA-Octreotate peptide receptor radionuclide therapy (PRRT) every 8 weeks, with the last 3 cycles being combined with talazoparib. Talazoparib will be administered in escalating doses, orally, daily during days 2-6 of these cycles.

Conditions

This trial is treating patients with pancreatic neuroendocrine tumours

Cancer

Neuroendocrine tumours Neuroendocrine tumours

Age

People18+

Phase

I

Trial Acronym

PARLuNET

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Peter MacCallum Cancer Centre

Scientific Title

Phase 1 Trial of PARP Inhibitor Combined With 177Lu-DOTA-Octreotate Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Metastatic NeuroEndocrine Tumor

Eligibility

Inclusion

  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 ≥ 60 ml/min

Exclusion

  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).

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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