Niraparib for the Treatment of Leiomyosarcoma

Sponsor
David Liebner, MD
Study ID
NCT05174455
Phase
PHASE2
Status
Withdrawn

Conditions

  • Locally Advanced Leiomyosarcoma
  • Metastatic Leiomyosarcoma
  • Stage III Retroperitoneal Sarcoma AJCC v8
  • Stage IIIA Retroperitoneal Sarcoma AJCC v8
  • Stage IIIB Retroperitoneal Sarcoma AJCC v8
  • Stage IV Retroperitoneal Sarcoma AJCC v8
  • Unresectable Leiomyosarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This phase II trial tests whether niraparib works to shrink tumor in patients with leiomyosarcoma. Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.

Key Dates

Start date
Dec 1, 2023
Status verified
Sep 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Niraparib)
    Patients receive niraparib PO QD. Cycles repeat every 28 days for 15 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Confirmed objective response rate (ORR) [ Time Frame: Within first 6 months of study treatment ]

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