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PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours
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).
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-12-08
Primary completion: 2029-06-30
Study completion finish: 2029-06-30
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05053854
Intervention or treatment
DRUG: Talazoparib
Conditions
- • Neuroendocrine Tumors
Find a site
Closest Location:
Peter MacCallum Cancer Centre
Research sites nearby
Select from list below to view details:
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: 177Lu-DOTA-Octreotate + talazoparib
| DRUG: Talazoparib
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Maximum tolerated dose Talazoparib with 177Lu-DOTA-Octreotate | Maximum tolerated dose of Talazoparib when given in combination with 177Lu-DOTA-Octreotate | Through study completion, up to 18 months following first administration of PRRT. |
Dose limiting toxicity talazoparib | The toxicity (haematologic or non-haematologic) that prevents further administration of the trial talazoparib treatment at that dose level. | Each cohort of 3 patients be assessed for DLTs in the first 6 weeks (cycle 2) of treatment and a dose for the next cohort will be determined (each cycle is 8 weeks) |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Adverse Events and Serious Adverse Events measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 | Safety of the combination will be measured by AEs and SAEs | Through Study completion, up to 18 months after the last patient commences treatment. |
Radiographic progression free survival | The time from treatment initiation to the first date of progression on imaging or death due to any cause. Imaging progression will be assessed by RECIST 1.1. Patients who commence new systemic therapy before evidence of disease progression on conventional imaging will be considered to have progressed. | Through study completion, up to 18 months following first administration of PRRT. |
Overall Survival | The time from treatment initiation to the date of death due to any cause. For patients alive, the time will be censored at the last time the patients was known to be alive. | Through study completion, up to 18 months following first administration of PRRT. |
Treatment discontinuation due to toxicity | The number of patients who discontinue treatment at any time due to treatment related toxicity will be reported and will be also categorised by dose level. | Through study completion, up to 18 months following first administration of PRRT. |
Rate of Treatment discontinuation due to toxicity | The percentage of patients who discontinue treatment due to treatment related toxicity will be reported and will be also categorised by dose level | Through study completion, up to 18 months following first administration of PRRT. |
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