Prospective multicenter study evaluating safety, tolerability and metabolism of niraparib as maintenance for ovarian cancer in women of African ancestry

Résumé

Large-scale clinical studies investigating the safety and efficacy of novel therapeutics in ovarian cancer rarely include Black women or women of African ancestry. The sampled population in the PRIMA study was only 1.6% Black. Our objective is to evaluate the safety and tolerability of maintenance niraparib treatment in women of African ancestry. We hypothesize that the Poly (ADP-ribose) polymerase inhibitor (PARP) niraparib administered at standard doses in a population of African ancestry may demonstrate different safety and efficacy profiles to those in the PRIMA trial who were of primarily European ancestry. We will conduct a prospective, single-arm, multicenter, international study of 70 women of African ancestry designed to evaluate the safety and efficacy of niraparib maintenance therapy following completion of primary treatment for epithelial ovarian cancer. Study sites will include the United States, Bahamas, and Nigeria. Eligible patients must have histologically confirmed high-grade serous or endometrioid ovarian carcinoma, completed primary treatment for newly diagnosed stage III or IV ovarian, fallopian tube, or primary peritoneal carcinoma (surgery and chemotherapy) with partial or complete response, and self-identify as Black or African or Afro-Caribbean. The primary endpoint is the proportion of women with any grade 3 or higher adverse event. Secondary endpoints and translational endpoints will include progression free survival, pharmacokinetics, quality of life assessments, and biomarkers of PARP inhibitor resistance and metabolism. Clinical Trial Registration https://clinicaltrials.gov/study/NCT06412120 , identifier NCT06412120.

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