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New treatment option for Neuroendocrine Tumors
Official title PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours
ClinicalTrials.gov ID: NCT05053854
What this study is testing
What is Talazoparib?
Talazoparib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for neuroendocrine tumors.
Also referred to as Combination product: 177Lu-DOTA-Octreotate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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
- 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...
- Participation in another clinical study with an investigational product or another systemic therapy administered in the last 3 weeks (except short acting SSA).
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.