A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations (TEMPUS TMPS-101)

General Information Age Group Adults Status Recruiting Protocol Number NCT05169437 Background Information The purpose of this research study is to see if Niraparib has any benefits at dose levels thought to be acceptable in earlier studies. The researchers want to find out what effects (good and bad) Niraparib has on locally advanced or metastatic solid tumors and a germline (can be inherited) or somatic (change that occurs in a single cell and is not inherited) tumor PALB2 (tPALB2) mutation. Offered At Inova Schar Cancer Institute 8081 Innovation Park Dr. Fairfax, VA 22031 A department of Inova Fairfax Hospital Inova Schar Cancer Institute Fair Oaks 3580 Joseph Siewick Dr., Suite 403 Fairfax, VA 22033 A department of Inova Fair Oaks Hospital Eligibility Information Adults 18 years of age or older Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor(s) Solid tumor tests positive for a pathogenic or likely pathogenic tPALB2 mutation Additional eligibility in protocol Ineligibility Information Other active concomitant malignancy that warrants systemic, biologic, or hormonal therapy Ovarian or prostate cancer Participants who relapsed while receiving platinum based therapy in the adjuvant/curative setting Participants who have received PARP inhibitor(s) in prior lines of treatment Participant has systolic BP >140 mmHg or diastolic BP >90 mmHg, despite optimal medical therapy Participant is immunocompromised Pregnancy/breastfeeding Additional ineligibility in protocol Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT05169437 Contact Information Contact Name Joshelynn Asis Contact Phone 571-472-0635 Contact Email Send Email