Genitourinary tract neoplasm Trials in Disease

Study on Niraparib for Patients with Advanced Urothelial Cancer After Initial Platinum Chemotherapy

This clinical trial is examining whether niraparib, a medication taken as a capsule, can help patients with advanced urothelial cancer maintain disease control after completing their initial chemotherapy treatment. Urothelial cancer affects the lining of the bladder and other parts of the urinary system, and this study specifically focuses on cases where the cancer cannot be surgically removed or has spread to other parts of the body.

Main inclusion criteria:

• You must have a confirmed diagnosis of urothelial cancer that cannot be removed by surgery or has spread to other parts of the body
• Your cancer must be measurable according to RECIST guidelines, which are standard rules used to measure how well cancer treatments are working
• You must have completed 4 to 6 cycles of platinum-based chemotherapy as your first treatment
• Your cancer must not have worsened after chemotherapy, meaning you have achieved complete response, partial response, or stable disease
• You must enroll within 28 days of a scan showing disease stability or response, and no more than 42 days after your last chemotherapy dose
• Blood and tumor tissue samples must be available to check for specific genetic changes, including BRCA genes and genes involved in DNA repair
• Your ECOG performance status must be 0-1, meaning you are able to carry out normal or light daily activities
• Both men and women within the specified age range can participate

Main exclusion criteria:

• Patients whose cancer worsened during their first chemotherapy treatment
• Patients who did not receive platinum-based chemotherapy as their first treatment
• Patients with medical conditions other than urothelial cancer
• Patients who belong to vulnerable populations requiring special protection or care

Focus and goal:

The primary goal of this trial is to determine whether niraparib can effectively prolong the time patients live without their disease getting worse. Participants will be randomly assigned to receive either niraparib or the best supportive care without the study medication. The study will monitor how long patients remain free from disease progression, assess their overall survival and quality of life, and track any side effects they may experience. Regular assessments will be conducted throughout the treatment phase to evaluate the effectiveness and safety of niraparib compared to supportive care alone. The trial is expected to conclude by March 2026.

Investigational drug:

The medication being tested is niraparib, marketed as Zejula 100 mg hard capsules. Niraparib belongs to a class of drugs called PARP inhibitors. It works by blocking an enzyme that helps cancer cells repair their damaged DNA. By preventing this repair process, niraparib causes cancer cells to die, which may help slow down or stop the growth of the cancer. In this trial, niraparib is being investigated as a maintenance treatment to extend the period during which the cancer does not progress after initial chemotherapy.