Niraparib Maintenance Treatment for Ovarian Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are receiving bevacizumab as maintenance treatment or have had recent investigational therapy, you may not be eligible to participate.
What data supports the effectiveness of the drug Niraparib for ovarian cancer?
Research shows that Niraparib, a drug used for maintenance treatment in ovarian cancer, significantly extends the time patients live without the disease getting worse compared to a placebo. This benefit is seen in patients regardless of specific genetic mutations, making it a promising option for many individuals with ovarian cancer.12345
Is niraparib safe for use in humans?
How does the drug niraparib differ from other treatments for ovarian cancer?
Niraparib is unique because it is a PARP inhibitor used as a maintenance treatment for ovarian cancer, extending the time patients remain free from disease progression after responding to platinum-based chemotherapy. Unlike some treatments, it is effective regardless of BRCA mutation status, making it a versatile option for a broader range of patients.13459
What is the purpose of this trial?
This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.
Research Team
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Eligibility Criteria
This trial is for adults with advanced Stage III or IV ovarian cancer who've had a good response to initial platinum-based chemotherapy. They must have completed at least 3 cycles of therapy and be within 12 weeks post-chemo. Participants need negative pregnancy tests, agree to genetic testing of their tumor, and can't have more than 9 chemo cycles.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Niraparib or placebo as maintenance treatment following response to front-line platinum-based chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and progression-free survival
Treatment Details
Interventions
- Niraparib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tesaro, Inc.
Lead Sponsor
Gynecologic Oncology Group
Collaborator
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
Myriad Genetics, Inc.
Industry Sponsor