Neuroendocrine TumorsPhase 1PARLuNETNCT05053854
PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours
A Phase 1 study testing Talazoparib in people with Neuroendocrine Tumors, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Talazoparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Dec 2021to 30 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Research Manager contact
Australia1 site, 1 recruiting
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
MC Research Manager, +61385596602, NMResearch@petermac.org
About this study
Official title: Phase 1 Trial of PARP Inhibitor Combined With 177Lu-DOTA-Octreotate Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Metastatic NeuroEndocrine Tumor
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).
Read the detailed 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.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Talazoparib
- Keywords
- NET
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalazoparibDrug
Also called Combination product: 177Lu-DOTA-Octreotate
During dose escalation, doses of talazoparib that can be administered are 0.1mg, 0.25mg, 0.5mg or 1mg oral daily. Talazoparib will be given on days 2-6 of each cycle of 177Lu-DOTA-Octreotate for cycles 2-4, every 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-DOTA-Octreotate + talazoparib | Experimental | 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. Receives: Drug: Talazoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose Talazoparib with 177Lu-DOTA-Octreotate
Maximum tolerated dose of Talazoparib when given in combination with 177Lu-DOTA-Octreotate
Measured: 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.
Measured: 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 outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Through study completion, up to 18 months following first administration of PRRT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start8 Dec 2021
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single arm, single centre, Phase 1 study
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053854
- Sponsor's protocol ID
- PMC67199
- Acronym
- PARLuNET
- Status last verified
- Feb 2025
- First submitted
- 2 Sep 2021
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of PARP Inhibitor Combined With 177Lu-DOTA-Octreotate Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Metastatic NeuroEndocrine Tumor
- ClinicalTrials.gov ID
- NCT05053854
- Acronym / sponsor ID
- PARLuNET / PMC67199
- Conditions
- Neuroendocrine Tumors
- Keywords
- NET
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single arm, single centre, Phase 1 study
| Arm | Type | Receives |
|---|---|---|
| 177Lu-DOTA-Octreotate + talazoparib | Experimental | Drug: TalazoparibPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TalazoparibAlso: Combination product: 177Lu-DOTA-OctreotateDuring dose escalation, doses of talazoparib that can be administered are 0.1mg, 0.25mg, 0.5mg or 1mg oral daily. Talazoparib will be given on days 2-6 of each cycle of 177Lu-DOTA-Octreotate for cycles 2-4, every 8 weeks | Drug | 177Lu-DOTA-Octreotate + talazoparib |
Primary outcome
Maximum tolerated dose Talazoparib with 177Lu-DOTA-Octreotate
Time frame: Through study completion, up to 18 months following first administration of PRRT.
Maximum tolerated dose of Talazoparib when given in combination with 177Lu-DOTA-Octreotate
Dose limiting toxicity talazoparib
Time frame: 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)
The toxicity (haematologic or non-haematologic) that prevents further administration of the trial talazoparib treatment at that dose level.
5 secondary outcomes
Adverse Events and Serious Adverse Events measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Time frame: Through Study completion, up to 18 months after the last patient commences treatment.
Radiographic progression free survival
Time frame: Through study completion, up to 18 months following first administration of PRRT.
Overall Survival
Time frame: Through study completion, up to 18 months following first administration of PRRT.
Treatment discontinuation due to toxicity
Time frame: Through study completion, up to 18 months following first administration of PRRT.
Rate of Treatment discontinuation due to toxicity
Time frame: Through study completion, up to 18 months following first administration of PRRT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Research Manager contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Talazoparib in people with Neuroendocrine Tumors, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grace Kong (85595000, NMResearch@petermac.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose Talazoparib with 177Lu-DOTA-Octreotate (time frame: Through study completion, up to 18 months following first administration of PRRT.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.