NCT04992013

Niraparib in Tumors Metastatic to the CNS

Genomically Guided Phase II Study to Evaluate the Clinical Benefit of Niraparib in Tumors Metastatic to the CNS

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to see how effective the drug niraparib is against cancer that has metastasized to the central nervous system (CNS). * This research study involves the study drug niraparib.

Detailed description

This is a single arm open-label study designed to evaluate the efficacy and safety of niraparib in treating cancer that has metastasized to the central nervous system (CNS). The U.S. Food and Drug Administration (FDA) has not approved niraparib for cancer metastasized to the central nervous system (CNS) but it has been approved for other uses. Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage associated with your diagnosis from occurring. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive the study drug for up to 2 years or until their disease worsens, they have unacceptable side effects, or they meet one of the criteria to be removed from the study. Participants will then be followed every 4 months for up to 2 years. It is expected that about 20 people will take part in this research study. GlaxoSmithKline, a pharmaceutical company, is supporting this research study by providing funding for the study, including the study drug.

Conditions

• Metastatic Cancer
• Central Nervous System Cancer

Interventions

Type	Name	Description
DRUG	Niraparib	Capsule taken by mouth

Timeline

• Start date: 2022-04-05
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2021-08-05
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study