Niraparib for Soft Tissue Sarcoma
Trial Summary
What is the purpose of this trial?
The purpose of this study is to test whether the study drug, niraparib, is effective against unresectable and/or metastatic soft tissue sarcoma with DDR mutations. The researchers will also study whether niraparib is safe and causes few or mild side effects, and whether there are groups of DDR mutations in soft tissue sarcoma cells that respond better to treatment with niraparib.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chemotherapy or investigational therapies, you must have completed them at least 4 weeks before starting the study drug. If you are on estrogen modulating therapies, you must have stopped them at least 2 weeks prior to the study drug administration.
How is the drug Niraparib different from other drugs for soft tissue sarcoma?
Niraparib is unique because it is a PARP inhibitor, which means it works by blocking a protein that helps repair DNA damage in cancer cells, potentially making it effective for certain cancers. This mechanism is different from other treatments like doxorubicin or pazopanib, which are more commonly used for soft tissue sarcomas and work through different pathways.12345
Research Team
Evan Rosenbaum, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
Adults with certain types of soft tissue or uterine sarcoma that can't be surgically removed and have spread, who've tried at least one other cancer treatment. They must have specific genetic changes in their tumor DNA related to the DDR pathway, measurable disease, good organ function, and a performance status indicating they can care for themselves. Women must not be pregnant and agree to contraception; men also need to use birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive niraparib to assess its effectiveness against unresectable and/or metastatic soft tissue sarcoma with DDR mutations
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Niraparib
Niraparib is already approved in European Union, United States, Canada for the following indications:
- Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
- Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
- Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School