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OncoMatch/Clinical Trials/NCT05870423

Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors

Is NCT05870423 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies olaparib for neuroendocrine tumors.

Phase 1RecruitingErasmus Medical CenterNCT05870423Data as of May 2026

Treatment: olaparibThis 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.

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Extracted eligibility criteria

Cancer type

Neuroendocrine Tumor

Disease stage

Grade: 123

Prior therapy

Must have received: peptide receptor radionuclide therapy (177Lu-DOTATATE) — initial or salvage

Disease progression based on RECIST v1.1 following initial or salvage treatment with PRRT with 177Lu-DOTATATE

Cannot have received: surgery

Exception: within 12 weeks prior to inclusion

Any surgery...within 12 weeks prior to inclusion in the study.

Cannot have received: radioembolization

Exception: within 12 weeks prior to inclusion

radioembolization...within 12 weeks prior to inclusion in the study.

Cannot have received: chemoembolization

Exception: within 12 weeks prior to inclusion

chemoembolization...within 12 weeks prior to inclusion in the study.

Cannot have received: chemotherapy

Exception: within 12 weeks prior to inclusion

chemotherapy...within 12 weeks prior to inclusion in the study.

Cannot have received: radiofrequency ablation

Exception: within 12 weeks prior to inclusion

radiofrequency ablation within 12 weeks prior to inclusion in the study.

Cannot have received: interferon (interferons)

Exception: within 4 weeks prior to inclusion

Interferons...within 4 weeks prior to inclusion in the study.

Cannot have received: mTOR inhibitor (everolimus)

Exception: within 4 weeks prior to inclusion

everolimus...within 4 weeks prior to inclusion in the study.

Cannot have received: VEGFR inhibitor (sunitinib)

Exception: within 4 weeks prior to inclusion

sunitinib...within 4 weeks prior to inclusion in the study.

Cannot have received: systemic therapy

Exception: within 4 weeks prior to inclusion

other systemic therapies within 4 weeks prior to inclusion in the study.

Cannot have received: external beam radiation therapy

Exception: to more than 25% of the bone marrow

Prior external beam radiation therapy to more than 25% of the bone marrow.

Lab requirements

Blood counts

Hb concentration <6.2 mmol/L; white blood cell count <3x10^9/L; platelets <100x10^9/L; neutrophil count <1.5x10^9/L

Kidney function

creatinine clearance <50 mL/min, measured in 24-hour urine collection

Liver function

total bilirubin >3 x ULN, ALT or AST > 2.5 x ULN or serum albumin <3.0 g/dL unless prothrombin time is within the normal range

Cardiac function

Uncontrolled congestive heart failure (NYHA II, III, IV) [excluded]

Hb concentration <6.2 mmol/L; white blood cell count <3x10^9/L; platelets <100x10^9/L; neutrophil count <1.5x10^9/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. Uncontrolled congestive heart failure (NYHA II, III, IV) [excluded].

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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