Status:
COMPLETED
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
Lead Sponsor:
Tesaro, Inc.
Collaborating Sponsors:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Myriad Genetics, Inc.
Conditions:
Ovarian Neoplasms
Platinum Sensitive Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with hi...
Eligibility Criteria
Inclusion
- 18 years of age or older, female, any race
- Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- High grade (or grade 3) serous histology or known to have gBRCAmut
- Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease)
- Has responded to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
- ECOG 0-1
- Adequate bone marrow, kidney and liver function
Exclusion
- Known hypersensitivity to the components of niraparib
- Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
- Symptomatic uncontrolled brain metastasis
- Is pregnant or breast feeding
- Immunocompromised patients
- Known active hepatic disease
- Prior treatment with a known PARP inhibitor
Key Trial Info
Start Date :
June 21 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2021
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT01847274
Start Date
June 21 2013
End Date
December 26 2021
Last Update
June 2 2023
Active Locations (112)
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1
GSK Investigational Site
Phoenix, Arizona, United States, 85013
2
GSK Investigational Site
Tucson, Arizona, United States, 85704
3
GSK Investigational Site
Los Angeles, California, United States, 90027
4
GSK Investigational Site
Los Angeles, California, United States, 90048