Breast Cancer Clinical Trial
Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors
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.
Eligibility Criteria
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 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.
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There are 76 Locations for this study
Yuma Arizona, 85364, United States
Springdale Arkansas, 72762, United States
Fountain Valley California, 92708, United States
Fullerton California, 92835, United States
La Jolla California, 92093, United States
Long Beach California, 90806, United States
Los Alamitos California, 90720, United States
Los Alamitos California, 90720, United States
Napa California, 94558, United States
Oxnard California, 93030, United States
San Diego California, 92123, United States
Santa Barbara California, 93105, United States
Santa Rosa California, 95403, United States
Hartford Connecticut, 06102, United States
Norwich Connecticut, 06360, United States
Fort Lauderdale Florida, 33308, United States
Jacksonville Florida, 32256, United States
Ocala Florida, 34474, United States
Athens Georgia, 30607, United States
Honolulu Hawaii, 96813, United States
Chicago Illinois, 60612, United States
Rolling Meadows Illinois, 60008, United States
Fort Wayne Indiana, 46845, United States
Goshen Indiana, 46526, United States
Indianapolis Indiana, 46250, United States
South Bend Indiana, 46601, United States
Hammond Louisiana, 70403, United States
Bethesda Maryland, 20817, United States
Frederick Maryland, 21702, United States
Rockville Maryland, 20850, United States
Fairhaven Massachusetts, 02719, United States
Lansing Michigan, 48912, United States
Bolivar Missouri, 65613, United States
Saint Joseph Missouri, 64507, United States
Springfield Missouri, 65807, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89102, United States
Belleville New Jersey, 07109, United States
Englewood New Jersey, 07631, United States
Florham Park New Jersey, 07932, United States
Charlotte North Carolina, 28204, United States
Goldsboro North Carolina, 27534, United States
Winston-Salem North Carolina, 27103, United States
Canton Ohio, 44708, United States
Cincinnati Ohio, 45220, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43214, United States
Toledo Ohio, 43623, United States
Tulsa Oklahoma, 74146, United States
Salem Oregon, 97301, United States
Gettysburg Pennsylvania, 17325, United States
Greenville South Carolina, 29607, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Memphis Tennessee, 38120, United States
Austin Texas, 78705, United States
Austin Texas, 78731, United States
Austin Texas, 78745, United States
Dallas Texas, 75230, United States
Dallas Texas, 75246, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Longview Texas, 75601, United States
Palestine Texas, 75801, United States
Paris Texas, 75460, United States
Sugar Land Texas, 77479, United States
Tyler Texas, 75702, United States
Ogden Utah, 84405, United States
Salt Lake City Utah, 84106, United States
Fairfax Virginia, 22031, United States
Fredericksburg Virginia, 22408, United States
Richmond Virginia, 23229, United States
Richmond Virginia, 23230, United States
Bellingham Washington, 98225, United States
Tacoma Washington, 98405, United States
Appleton Wisconsin, 54911, United States
Madison Wisconsin, 53717, United States
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