Niraparib for Soft Tissue Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called niraparib to determine its effectiveness in treating soft tissue sarcoma that cannot be surgically removed or has metastasized. Researchers aim to assess the drug's efficacy and safety and whether certain genetic mutations in the cancer respond better to the treatment. Individuals diagnosed with unresectable or metastatic soft tissue sarcoma and specific genetic mutations may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings.
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.
Is there any evidence suggesting that niraparib is likely to be safe for humans?
Research has shown that niraparib has been tested in various conditions, and safety information is available. In other studies, patients generally tolerated niraparib well. Common side effects include nausea, fatigue, and low blood cell counts, but these are usually mild and manageable.
No evidence indicates major safety risks, and niraparib already has FDA approval for other uses, confirming its safety for humans when used as directed.
Overall, while any treatment can have side effects, most patients generally tolerate niraparib well.12345Why do researchers think this study treatment might be promising for soft tissue sarcoma?
Niraparib is unique because it targets cancer cells by inhibiting a specific enzyme called PARP (poly ADP-ribose polymerase), which is crucial for DNA repair. Unlike traditional chemotherapy for soft tissue sarcoma, which generally attacks rapidly dividing cells indiscriminately, Niraparib specifically exploits the weaknesses in cancer cells' DNA repair mechanisms. This targeted approach potentially offers a more focused treatment option with fewer side effects. Researchers are excited about Niraparib because it may prevent tumor growth more effectively and provide a new option for patients whose cancer has been difficult to treat with standard therapies.
What evidence suggests that niraparib might be an effective treatment for soft tissue sarcoma?
Research shows that niraparib, the investigational treatment in this trial, blocks a protein involved in DNA repair and might help treat soft tissue sarcomas with certain genetic changes. Studies have found that niraparib targets these changes, increasing the likelihood of cancer cells responding to treatment. Early results suggest that patients with these genetic changes may benefit from niraparib, with some studies reporting tumor shrinkage. Other research highlights niraparib as a promising treatment for these cancers. Overall, evidence supports niraparib's potential to effectively treat soft tissue sarcomas with these genetic changes.12367
Who Is on the Research Team?
Sujana Movva, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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