A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

Status:	Completed
Conditions:	Ovarian Cancer, Neurology
Therapuetic Areas:	Neurology, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	12/14/2016
Start Date:	June 2013
End Date:	June 2016

A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.

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 high-grade serous histology and who have responded to their most
recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP
inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily
continuously during a 28-day cycle. Health-related quality of life will be measured by the
Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of
Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability
will be assessed by clinical review of adverse events (AEs), physical examinations,
electrocardiograms (ECGs), and safety laboratory values.

The primary objective of this study is to evaluate efficacy of niraparib as maintenance
therapy in patients who have platinum sensitive ovarian cancer as assessed by the
prolongation of progression free survival (PFS).

Inclusion Criteria:

- 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 Criteria:

- 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

We found this trial at

sites

Clinical Trial Facility in Minneapolis Minnesota

Minneapolis, Minnesota 55455

from

Minneapolis, MN