Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

Duration of Response (DOR) - Independent Central Review (ICR)

To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1

Time frame: Up to 4 years

Progression-Free Survival (PFS) - Independent Central Review (ICR)

To evaluate progression-free survival (PFS) as assessed by ICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

Time frame: Up to 4 years

Overall Response Rate (ORR) - Investigator

To evaluate ORR as defined as the proportion of patients who had a partial or complete response (PR or CR) to therapy, as assessed by Investigator using RECIST v1.1 and assessed periodically throughout the treatment period based on imaging every 8 weeks (56 ± 7 days).

Time frame: 2 years 3 months

Duration of Response (DOR) - Investigator

To evaluate DOR as assessed by Investigator using RECIST v1.1 defined as from first documentation of objective tumor response (CR or PR) to first documentation of objective tumor progression or death due to any cause.

Time frame: 2 years 3 months

Progression-Free Survival (PFS) - Investigator

To evaluate PFS as assessed by Investigator using RECIST v1.1 determined from the first dose to the date of first radiographic progression or death from any cause in the absence of progression, whichever occurred first, or were censored.

Time frame: 2 years 3 months

Clinical Benefit Rate (CBR) - Investigator and ICR

To evaluate Clinical Benefit Rate (CBR), defined as the percentage of patients who had achieved Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for 8 weeks or more, as assessed by Investigator only (ICR not performed due to early study termination).

Time frame: 2 years 3 months

ORR With Untreated Measurable CNS Lesions - Investigator

To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by Investigator using RECIST v1.1

Time frame: Up to 4 years

ORR With Untreated Measurable CNS Lesions - ICR

To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by ICR using RECIST v1.1

Time frame: Up to 4 years

Number of Participants With Treatment-Emergent Adverse Events

To evaluate safety and tolerability per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)

Time frame: 2 years 3 months

Overall Survival (OS)

To evaluate overall survival (OS) defined as the time from the date of first dose of study drug to the date of death by any cause. Patients who were alive were censored at the date of last contact.

Time frame: 6 months and 12 months