Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors
Recruiting now · Phase 1
Conditions studied: Neuroendocrine Tumors, Peptide Receptor Radionuclide Therapy
In brief
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.
Key facts
- Study ID
- NCT05870423
- Run by
- Erasmus Medical Center
- People needed
- 24
- Starts
- 2022-06-01
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2025-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 least 12 months since first cycle of previous administration of PRRT or with no suitable systemic alternative treatment options.
- 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.
You may not qualify 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) > 2.5 x ULN or serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
- 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 prior to inclusion in the study.
- 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 interfere with the study evaluation, procedures or completion.
- Known allergy or intolerance for the (non-)investigational drugs.
- Inability to provide informed consent.
- End of life care.
Where it is running
- Erasmus MC — Rotterdam, South Holland, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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