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New treatment option for Neuroendocrine Tumors
Official title Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors
ClinicalTrials.gov ID: NCT05870423
What this study is testing
What is olaparib?
olaparib is an investigational medicine, being studied as a potential treatment for neuroendocrine tumors.
Also referred to as Lynparza.
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 is a phase 1 dose-escalation study to determine the maximum tolerated dose of the PARP inhibitor olaparib in combination with PRRT in patients with a well-differentiated advanced gastroenteropancreatic NET (GEP NET), progressive after PRRT. As secondary objectives, efficacy, pharmacokinetics and biomarker response will be investigated.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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
- Histologically proven locally advanced or metastatic, well-differentiated (grade 1, 2 or 3) NET.
- Disease progression based on RECIST v1.1 following initial or salvage treatment with PRRT with 177Lu-DOTATATE with a progression free interval of at...
- The patient is eligible for two cycles of salvage PRRT.
- Measurable disease according to RECIST v1.1 on CT/MRI.
- Confirmed presence of somatostatin receptors on all target lesions on CT/MRI, based on positive uptake on a 68Ga-DOTATATE/-TOC/-NOC PET-CT/MRI scan.
You likely can't join if
- Hb concentration \<6.2 mmol/L; white blood cell count \<3x109/L; platelets \<100x109/L; neutrophil count \<1.5x109/L.
- Renal insufficiency defined as a creatinine clearance \<50 mL/min, measured in 24-hour urine collection.
- Liver function or enzyme abnormalities defined as a total bilirubin \>3 x ULN, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>...
- Pregnancy, lactation and inability to comply with effective means of contraception in females of child-bearing age.
- Neuroendocrine carcinoma of any origin.
- Any surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation within 12 weeks prior to inclusion in the study...
See the full eligibility criteria
- Histologically proven locally advanced or metastatic, well-differentiated (grade 1, 2 or 3) NET.
- Disease progression based on RECIST v1.1 following initial or salvage treatment with PRRT with 177Lu-DOTATATE with a progression free interval of at least 12 months since first cycle of previous administration of PRRT...
- The patient is eligible for two cycles of salvage PRRT.
- Measurable disease according to RECIST v1.1 on CT/MRI.
- Confirmed presence of somatostatin receptors on all target lesions on CT/MRI, based on positive uptake on a 68Ga-DOTATATE/-TOC/-NOC PET-CT/MRI scan.
- Age ≥ 18 years.
- Karnofsky Performance Score (KPS) \> 60.
- Hb concentration \<6.2 mmol/L; white blood cell count \<3x109/L; platelets \<100x109/L; neutrophil count \<1.5x109/L.
- Renal insufficiency defined as a creatinine clearance \<50 mL/min, measured in 24-hour urine collection.
- Liver function or enzyme abnormalities defined as a total bilirubin \>3 x ULN, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 x ULN or serum albumin \<3.0 g/dL unless prothrombin time is...
- Pregnancy, lactation and inability to comply with effective means of contraception in females of child-bearing age.
- Neuroendocrine carcinoma of any origin.
- Any surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation within 12 weeks prior to inclusion in the study. Interferons, everolimus, sunitinib or other systemic therapies within 4 weeks...
- Uncontrolled congestive heart failure (NYHA II, III, IV).
- Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with the completion of the study.
- Prior external beam radiation therapy to more than 25% of the bone marrow.
- Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years.
- Patients who use a strong CYP3A4 inhibitor within 1 week before start of the treatment or a CYP3A4 inducer within 4 weeks before start of the treatment.
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or...
- Known allergy or intolerance for the (non-)investigational drugs.
- Inability to provide informed consent.
- End of life care.
The study team makes the final eligibility decision.
Where it's taking place
- Rotterdam, South Holland, Netherlands
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 Rotterdam, South Holland, Netherlands. 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.