A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA (NCT05515575) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA
United States8 participantsStarted 2022-08-23
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years at the time of informed consent
* Participants or their legally authorized representatives (LARs) need to be willing to provide written informed consent/assent for the trial
* Be willing to comply with treatment protocol
* Histologically confirmed unresectable or metastatic soft tissue or uterine sarcoma
* Known deleterious or suspected deleterious alteration in at least one of the following prespecified DDR pathway genes:
Core Genes
Gene Pathway
BRCA1 FA/HR
BRCA2 FA/HR
BRIP1 FA/HR
BARD1 FA/HR
BLM FA/HR
PALB2 FA
MRE11 HR
NBN HR
RAD50 HR/NHEJ
RAD51B FA/HR
RAD51C HR
RAD51D HR
RAD52 HR
RAD54B HR
Other Genes
Gene Pathway
ABRAXAS1 NHEJ
ATM OTHER
ATR OTHER
CHEK1 OTHER
CHEK2 OTHER
ERCC4 NER
ERCC8 NER
FANCA FA
FANCC FA
FANCD2 FA
FANCE FA
FANCF FA
FANCG FA
FANCI FA
FANCL FA
FANCM FA/HR
MDC1 OTHER
PARP1 BER
RAD23B NER
RECQL4 HR
RPA1 NER
SLX4 FA/HR
XRCC2 FA/HR
XRCC4 NHEJ
XRCC6 NHEJ
A= Fanconi Anemia BER = Base Excision Repair NER = Nucleotide Excision Repair HR = Homologous Recombination NHEJ = Non-homologous End Joining
* Additional genes may be added to Appendix 18.1 in a study addendum as medical and scientific research and/or diagnostic testing evolves
* Alterations of uncertain significance must be approved for inclusion by the Principal Investigator
* Performance status of ECOG ≤ 2
* Progressed on at least 1 prior line of systemic therapy.
* Patients who decline standard of care first-line syst…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.