Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

Stopped early · Phase 2

Conditions studied: Solid Tumor, Breast Tumor, Colon Tumor, Malignant, Lung Tumor, Urologic Cancer, Pancreatic Cancer, Melanoma, Metastatic Cancer, Locally Advanced Solid Tumor, Esophageal Cancer, Endometrial Cancer, Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT05169437

Run by

Tempus AI

People needed

22

Starts

2022-03-15

Expected to finish

2024-08-27

Last updated by the study team

2025-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Highlands Oncology — Springdale, Arkansas, United States
• Memorial Care Medical Center — Fountain Valley, California, United States
• St Joseph Heritage Health - Fullerton — Fullerton, California, United States
• University of California San Diego — La Jolla, California, United States
• MemorialCare — Long Beach, California, United States
• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
• Cancer and Blood Specialty — Los Alamitos, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• St Joseph Health Medical Group - Napa — Napa, California, United States
• Ventura County Hematology Oncology Specialists — Oxnard, California, United States
• Sharp Healthcare — San Diego, California, United States
• Ridley-Tree Cancer Center — Santa Barbara, California, United States
• St Joseph Health Medical Group - Santa Rosa — Santa Rosa, California, United States
• Hartford Healthcare — Hartford, Connecticut, United States
• Eastern Connecticut Hematology and Oncology — Norwich, Connecticut, United States
• Holy Cross — Fort Lauderdale, Florida, United States
• Cancer Specialists of North Florida — Jacksonville, Florida, United States
• Ocala Community Cancer Center — Ocala, Florida, United States
• University Cancer & Blood Center — Athens, Georgia, United States
• Hawaii Cancer Care — Honolulu, Hawaii, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Northwest Oncology & Hematology — Rolling Meadows, Illinois, United States
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
• Goshen Health — Goshen, Indiana, United States
• Yuma Regional Medical Center — Yuma, Arizona, United States

Full record on ClinicalTrials.gov

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