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OncoMatch/Clinical Trials/NCT06078787

Olaparib in PALB2 Advanced Pancreatic Cancer

Is NCT06078787 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Olaparib 150 MG for advanced pancreatic cancer.

Phase 2RecruitingAzienda Ospedaliero-Universitaria di ModenaNCT06078787Data as of May 2026

Treatment: Olaparib 150 MGThis is a Phase II, non-randomized, multicenter, unblinded open-label study of Olaparib in monotherapy in participants with advanced (locally advanced/metastatic) PALB2-related pancreatic cancer that have progressed after at least one treatment for advanced disease.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Biomarker criteria

Required: PALB2 deleterious or suspected deleterious mutation

documented mutation in PALB2 gene (germline or somatic) that is predicted to be deleterious or suspected deleterious

Excluded: PALB2 benign variant

Has a benign variant of PALB2 gene

Excluded: PALB2 variant of uncertain (or unknown) significance (VUS)

variant of uncertain (or unknown) significance (VUS)

Disease stage

Required: Stage IV (AJCC 8th Edition)

advanced (unresectable or metastatic) pancreatic cancer by American Joint Committee on Cancer 8th Edition

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: systemic therapy — advanced disease (locally advanced or metastatic)

Has received at least one systemic treatment for advanced disease (locally advanced or metastatic disease)

Cannot have received: PARP inhibitor (olaparib)

Any previous treatment with PARP inhibitor, including Olaparib

Cannot have received: systemic chemotherapy

Exception: except for palliative reasons

Has prior systemic chemotherapy, targeted small molecule therapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment

Cannot have received: targeted small molecule therapy

Has prior systemic chemotherapy, targeted small molecule therapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment

Cannot have received: radiotherapy

Exception: except for palliative reasons

Has prior systemic chemotherapy, targeted small molecule therapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment

Cannot have received: anti-monoclonal antibody

Has received prior therapy with an anti-monoclonal antibody within 4 weeks or who has not recovered (i.e. <= G1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier

Cannot have received: allogenic bone marrow transplant

Has received previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)

Cannot have received: double umbilical cord blood transplantation

Has received previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)

Cannot have received: whole blood transfusion

Exception: packed red blood cells and platelet transfusions are acceptable if not performed within 28 days of the first dose

Has received a whole blood transfusions in the last 120 days prior to entry to the study. Packed red blood cells and platelet transfusions are acceptable, if not performed within 28 days of the first dose of study intervention

Lab requirements

Blood counts

adequate organ function as defined in Table 2; all screening laboratory tests should be performed within 10 days prior to initiation of study intervention

Kidney function

adequate organ function as defined in Table 2; all screening laboratory tests should be performed within 10 days prior to initiation of study intervention

Liver function

adequate organ function as defined in Table 2; all screening laboratory tests should be performed within 10 days prior to initiation of study intervention

Has adequate organ function as defined in Table 2; all screening laboratory tests should be performed within 10 days prior to initiation of study intervention

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

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