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


Phase 3
18 Years
N/A
Not Enrolling
Female
Platinum Sensitive Ovarian Cancer

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Trial Information

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


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 is considered platinum sensitive (more than 6 month period between
penultimate platinum regimen and progression of disease) and has response to last
platinum regimen

- ECOG 0-2

- Adequate bone marrow, kidney and liver functi

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression free survival of ovarian cancer patients

Outcome Description:

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).

Outcome Time Frame:

35 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

PR-30-5011-C

NCT ID:

NCT01847274

Start Date:

May 2013

Completion Date:

Related Keywords:

  • Platinum Sensitive Ovarian Cancer
  • ovarian cancer
  • platinum sensitive
  • gBRACAmut
  • high-grade serous histology
  • Ovarian Neoplasms

Name

Location

TesaroWaltham, Massachusetts  02451