Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 29, 2025 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Tempus AI
- Interventions being studied
- Drug: Niraparib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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 who relapsed while receiving platinum based therapy in the adjuvant/curative setting.
- Participants progressing within 14-18 weeks while receiving platinum based therapy in the metastatic setting.
- Participants who have received Poly (ADP-ribose) polymerase (PARP) inhibitor(s) in prior lines of treatment.
- Participants with leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage.
- Participants with germline or somatic BRCA1 or BRCA2 mutations.
- Participant has systolic blood pressure (BP) over 140 mmHg or diastolic BP over 90 mmHg, despite optimal medical therapy.
- Participants have previously or are currently participating in a treatment study of an investigational agent within 3 weeks of the first dose of therapy preceding the study.
- Participants have received prior systemic cytotoxic chemotherapy, biological therapy, or hormonal therapy for cancer, or received radiation therapy within 3 weeks of the first dose therapy preceding the study.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Yuma Regional Medical CenterYuma, Arizona
- Highlands OncologySpringdale, Arkansas
- Memorial Care Medical CenterFountain Valley, California
- St Joseph Heritage Health - FullertonFullerton, California
- University of California San DiegoLa Jolla, California
- MemorialCareLong Beach, California
- Cancer and Blood Specialty ClinicLos Alamitos, California
- Cancer and Blood SpecialtyLos Alamitos, California
- University of California Los AngelesLos Angeles, California
- St Joseph Health Medical Group - NapaNapa, California
- Ventura County Hematology Oncology SpecialistsOxnard, California
- Sharp HealthcareSan Diego, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 29, 2025. Always confirm current availability with the study team.