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Trial record 1 of 1 for:    NCT01847274
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A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT01847274
Recruitment Status : Completed
First Posted : May 6, 2013
Last Update Posted : December 13, 2016
Information provided by (Responsible Party):

Study Description
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 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).

Condition or disease Intervention/treatment Phase
Platinum Sensitive Ovarian Cancer Drug: Active comparator: Niraparib Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 597 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
Study Start Date : June 2013
Primary Completion Date : June 2016
Study Completion Date : June 2016

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Niraparib
2:1 Ratio administered once daily continuously during a 28 day cycle.
Drug: Active comparator: Niraparib
Niraparib vs placebo 2:1 ratio
Other Name: Niraparib
Placebo Comparator: Placebo
Administered once daily continuously over a 28 day cycle.
Drug: placebo

Outcome Measures

Primary Outcome Measures :
  1. Progression free survival of ovarian cancer patients [ Time Frame: 35 months ]
    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). In the non-gBRCAmut cohort, PFS will be hierarchically evaluated first in HRD+ patients and then in all non-gBRCAmut patients.

Secondary Outcome Measures :
  1. Patient Reported Outcomes [ Time Frame: 35 months ]
    Functional Assessment of Cancer therapy - Ovarian Symptom Index (FOSI) EQ-5D-5L Neuropathy Questionnaire

  2. Progression Free Survival Two [ Time Frame: 35 months ]
    Time from treatment randomization to the earlier date of assessment of progression on the next anti-cancer therapy following study treatment or death by any cause.

  3. Chemotherapy Free Interval [ Time Frame: 35 Months ]
    Chemotherapy free interval (CFI) is the time from last platinum dose until initiation of the next anticancer therapy

  4. Overall Survival of Ovarian Cancer Patients [ Time Frame: 35 Months ]
  5. Evaluate the safety and tolerability of niraparib in ovarian cancer patients [ Time Frame: 35 months ]
    Review of adverse events, physical exams, electrocardiograms (ECGs), and safety lab values

  6. BRACA diagnostic test [ Time Frame: 35 months ]
    Concordance of a candidate companion diagnostic test compared to centralized BRCA mutation test

  7. HRD diagnostic test [ Time Frame: 35 months ]
    Concordance of a candidate companion HRD diagnostic test compared to centralized HRD test

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847274

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United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
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La Jolla, California, United States
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Sponsors and Collaborators
Tesaro, Inc.
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Myriad Genetics, Inc.
US Oncology Research
Sarah Cannon
Cooperative Ovarian Cancer Group for Immunotherapy (COGI) Network
Facing Our Risk of Cancer Empowered
Principal Investigator: Mansoor Raza Mirza, MD Rigshospitalet, Denmark
Principal Investigator: Ursula Matulonis, MD Dana-Farber Cancer Institute
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT01847274     History of Changes
Other Study ID Numbers: PR-30-5011-C
First Posted: May 6, 2013    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016

Keywords provided by Tesaro, Inc.:
ovarian cancer
platinum sensitive
high-grade serous histology
PARP inhibitor

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Immune System Diseases
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents