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

Tesaro

Status and phase: Completed; Phase 3

Conditions: Ovarian Neoplasms; Platinum Sensitive Ovarian Cancer

Treatments: Drug: Active comparator: Niraparib; Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01847274

PR-30-5011-C (Other Identifier)

213356

Details and patient eligibility

About

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).

Enrollment: 596 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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596 participants in 2 patient groups, including a placebo group

Niraparib

Active Comparator group

Description:

2:1 Ratio administered once daily continuously during a 28 day cycle.

Treatment:

Drug: Active comparator: Niraparib

Placebo

Placebo Comparator group

Description:

Administered once daily continuously over a 28 day cycle.

Treatment:

Drug: placebo