A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
PAVO is an open-label Phase II study investigating if the study drug, a PARP inhibitor called niraparib (Zejula), is safe and effective for certain people who have been diagnosed with an advanced solid tumor with either an inherited or tumor PALB2 mutation.
All participants will receive the study drug, niraparib. Study participants will be dosed with niraparib orally once daily throughout each 28-day cycle and be evaluated via CT or MRI scans every 8 weeks for approximately one year.
The PALB2-mutation is present in 1.66% of solid tumor patients. While present at a much lower frequency than other HRR-related genes (BRCA1/2), PALB2 is similarly associated with an increased risk of cancer.1
Similar to BRCA, PALB2 is also considered a potent regulator of the homologous recombination repair (HRR) pathway. Therefore, one potential avenue to treat this population is with poly (ADP-ribose) polymerase inhibitors (PARPi) such as niraparib, which prevent DNA damage repair and promote cancer cell cytotoxicity. Recent studies demonstrate that patients with metastatic breast and advanced pancreatic cancers with inherited PALB2 mutations have achieved clinical benefit from treatment with PARP inhibitors.2,3
Individuals interested in joining the study should talk with their doctor.View the PAVO Study, NCT05169437
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