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

Who is this study for? Patients with metastatic neuroendocrine tumor
What treatments are being studied? Talazoparib
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Contact Information
Primary
Grace Kong
NMResearch@petermac.org
85595000
Backup
Research Manager
8559 6602
Time Frame
Start Date: 2021-12-08
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 24
Treatments
Experimental: 177Lu-DOTA-Octreotate + talazoparib
Patients will receive 4 cycles of 177Lu-DOTA-Octreotate every 8 weeks, the last 3 cycles combined with talazoparib on days 2-6 of each cycle.
Related Therapeutic Areas
Sponsors
Leads: Peter MacCallum Cancer Centre, Australia

This content was sourced from clinicaltrials.gov

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