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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Tesaro, Inc.
Sponsor:
Collaborators:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Myriad Genetics
US Oncology Research
Sarah Cannon
Cooperative Ovarian Cancer Group for Immunotherapy (COGI) Network
Facing Our Risk of Cancer Empowered (FORCE)
Information provided by (Responsible Party):
Tesaro, Inc.
ClinicalTrials.gov Identifier:
NCT01847274
First received: April 11, 2013
Last updated: September 25, 2014
Last verified: September 2014

April 11, 2013
September 25, 2014
June 2013
March 2016   (final data collection date for primary outcome measure)
Progression free survival of ovarian cancer patients [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]
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).
Same as current
Complete list of historical versions of study NCT01847274 on ClinicalTrials.gov Archive Site
  • Patient Reported Outcomes [ Time Frame: 35 months ] [ Designated as safety issue: No ]
    Functional Assessment of Cancer therapy - Ovarian Symptom Index (FOSI) EQ-5D-5L Neuropathy Questionnaire
  • Progression Free Survival Two [ Time Frame: 35 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Evaluate the safety and tolerability of niraparib in ovarian cancer patients [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]
    Review of adverse events, physical exams, electrocardiograms (ECGs), and safety lab values
  • BRACA diagnostic test [ Time Frame: 35 months ] [ Designated as safety issue: No ]
    Concordance of a candidate companion diagnostic test compared to centralized BRCA mutation test
Same as current
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
October 2016
March 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
Female
18 Years and older
No
Contact: Shefali Agarwal, MD 781-916-8375 Sagarwal@tesarobio.com
United States,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Hungary,   Israel,   Italy,   Norway,   Poland,   Spain,   Sweden,   United Kingdom
 
NCT01847274
PR-30-5011-C
Yes
Tesaro, Inc.
Tesaro, Inc.
  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • Myriad Genetics
  • US Oncology Research
  • Sarah Cannon
  • Cooperative Ovarian Cancer Group for Immunotherapy (COGI) Network
  • Facing Our Risk of Cancer Empowered (FORCE)
Principal Investigator: Mansoor Raza Mirza, MD Rigshospitalet, Denmark
Principal Investigator: Ursula Matulonis, MD Dana-Farber Cancer Institute
Tesaro, Inc.
September 2014

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