About this trial
Investigational Products: Niraparib Period: 3 years after IRB/EC approval Indication: Adult patients with histologically confirmed and locally advanced, unresectable, or metastatic solid tumors having known or suspected deleterious mutations in genes involved in homologous recombination repair (HRR) or homologous recombination deficiency identified by whole genome sequencing
Eligibility criteria
Qualifiers
Patient who agreed to participate in the KOSMOS-II master observation study.
19 years of age or older on the day of signing informed consent.
Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor.
Has either known or suspected deleterious mutations in at least 1 of the genes involved in HRR or centrally confirmed HRD based on whole-genome sequencing (WGS).
Disqualifiers
Any previous exposure to PARP inhibitor
Any other active malignancy or diagnosis of another malignancy within 2 years before study enrollment
Has leptomeningeal metastases.
Active central nervous system (CNS) lesions.
Trial design
Treatments tested in this trial
- Niraparib