Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors (NCT05169437) | Clinical Trial Compass
TerminatedPhase 2
Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors
Stopped: Recruitment challenges
United States22 participantsStarted 2022-03-15
Plain-language summary
The purpose of this study is to further evaluate the efficacy and safety of niraparib in patients with locally advanced or metastatic solid tumors and a pathogenic or likely pathogenic tumor PALB2 (tPALB2) mutation.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must be at least 18 years of age or older.
* Participants must have a histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor(s).
* Participants must have tested positive for a pathogenic or likely pathogenic tPALB2 gene mutation using a CLIA-certified laboratory as described in the Next-Generation Sequencing (NGS) Laboratory Manual.
* Participants who have stable and asymptomatic Central Nervous System (CNS) disease must be receiving a stable (for at least 7 days) or decreasing corticosteroid dose at the time of study entry.
* Participants must submit fresh or archived (collected within 24 months of enrollment) Formalin-Fixed Paraffin-Embedded (FFPE) tumor sample to the central laboratory for post-enrollment confirmation of tPALB2 status.
* Participants must have received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the Investigator, the patient would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy, or the participant has no satisfactory alternative treatments.
Exclusion Criteria:
* Participants have other active concomitant malignancy that warrants systemic, biologic, or hormonal therapy.
* Participants who have ovarian or prostate cancer.
* Participants who have variants of undetermined significance (VUS), but not pathogenic variants of PALB2, at the time of screening.
* Participants …
What they're measuring
1
Overall Response Rate (ORR) - Independent Central Review (ICR)