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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01847274
First Posted: May 6, 2013
Last Update Posted: December 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
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
Information provided by (Responsible Party):
Tesaro, Inc.
April 11, 2013
May 6, 2013
December 13, 2016
June 2013
June 2016   (Final data collection date for primary outcome measure)
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.
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).
Complete list of historical versions of study NCT01847274 on ClinicalTrials.gov Archive Site
  • Patient Reported Outcomes [ Time Frame: 35 months ]
    Functional Assessment of Cancer therapy - Ovarian Symptom Index (FOSI) EQ-5D-5L Neuropathy Questionnaire
  • 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.
  • 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
  • Overall Survival of Ovarian Cancer Patients [ Time Frame: 35 Months ]
  • 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
  • BRACA diagnostic test [ Time Frame: 35 months ]
    Concordance of a candidate companion diagnostic test compared to centralized BRCA mutation test
  • HRD diagnostic test [ Time Frame: 35 months ]
    Concordance of a candidate companion HRD diagnostic test compared to centralized HRD test
  • Patient Reported Outcomes [ Time Frame: 35 months ]
    Functional Assessment of Cancer therapy - Ovarian Symptom Index (FOSI) EQ-5D-5L Neuropathy Questionnaire
  • 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.
  • 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
  • Overall Survival of Ovarian Cancer Patients [ Time Frame: 35 Months ]
  • 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
  • BRACA diagnostic test [ Time Frame: 35 months ]
    Concordance of a candidate companion diagnostic test compared to centralized BRCA mutation test
Not Provided
Not Provided
 
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Platinum Sensitive Ovarian Cancer
  • Drug: Active comparator: Niraparib
    Niraparib vs placebo 2:1 ratio
    Other Name: Niraparib
  • Drug: placebo
  • Active Comparator: Niraparib
    2:1 Ratio administered once daily continuously during a 28 day cycle.
    Intervention: Drug: Active comparator: Niraparib
  • Placebo Comparator: Placebo
    Administered once daily continuously over a 28 day cycle.
    Intervention: Drug: placebo
Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, Fabbro M, Ledermann JA, Lorusso D, Vergote I, Ben-Baruch NE, Marth C, Mądry R, Christensen RD, Berek JS, Dørum A, Tinker AV, du Bois A, González-Martín A, Follana P, Benigno B, Rosenberg P, Gilbert L, Rimel BJ, Buscema J, Balser JP, Agarwal S, Matulonis UA; ENGOT-OV16/NOVA Investigators. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016 Dec 1;375(22):2154-2164. Epub 2016 Oct 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
597
June 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Hungary,   Israel,   Italy,   Norway,   Poland,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT01847274
PR-30-5011-C
Yes
Not Provided
Not Provided
Tesaro, Inc.
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
Tesaro, Inc.
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP