Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

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.
 
ClinicalTrials.gov Identifier: NCT02655016
Recruitment Status : Active, not recruiting
First Posted : January 13, 2016
Last Update Posted : August 1, 2018
Sponsor:
Collaborators:
Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Myriad Genetics, Inc.
Information provided by (Responsible Party):
Tesaro, Inc.

Tracking Information
First Submitted Date  ICMJE December 8, 2015
First Posted Date  ICMJE January 13, 2016
Last Update Posted Date August 1, 2018
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
Progression Free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first - Approximately 15 months ]
The time from treatment randomization to the earlier date of assessment of progression or death by any cause in the absence of progression.
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
Progression Free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first - Approximately 10 months ]
The time from treatment randomization to the earlier date of assessment of progression or death by any cause in the absence of progression.
Change History Complete list of historical versions of study NCT02655016 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
  • Overall Survival [ Time Frame: 48 months ]
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
  • Safety and tolerability of Niraparib versus Placebo as Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: 48 months ]
    From date of screening until the date of study discontinuation or date of death from any cause, whichever came first
  • Patient Reported Outcomes (PROs) [ Time Frame: 48 months ]
  • Time to progression on the next anticancer therapy (PFS2) [ Time Frame: 48 months ]
    From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • Overall Survival [ Time Frame: 36 months ]
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
  • Safety and tolerability of Niraparib versus Placebo as Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: Approximately 36 months ]
    From date of screening until the date of study discontinuation or date of death from any cause, whichever came first
  • Patient Reported Outcomes (PROs) [ Time Frame: PROs are administered from screening until 12 weeks post study discontinuation or death from any cause. Approximately 36 months ]
  • Time to progression on the next anticancer therapy (PFS2) [ Time Frame: Approximately 36 months ]
    From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first.
Current Other Pre-specified Outcome Measures
 (submitted: February 21, 2017)
  • AUC0-last [ Time Frame: Up to 32 weeks ]
    AUC Area Under the Curve, time from 0 to the last quantifiable concentration
  • AUC [ Time Frame: Up to 32 weeks ]
    AUC Area Under the Curve, time from 0 to the last quantifiable concentration
  • Peak Plasma Concentration (Cmax) [ Time Frame: Up to 32 weeks ]
    Cmax Observed maximum plasma concentration
  • HRD Diagnostic Test [ Time Frame: Samples for BRCA and HRD diagnostic testing will be obtained at screening and tested during the study. Additional biomarkers may be tested from an optional tumor sample if available at study treatment discontinuation, approximately 48 months ]
Original Other Pre-specified Outcome Measures
 (submitted: January 12, 2016)
  • AUC0-last [ Time Frame: Up to 32 weeks ]
    AUC Area Under the Curve, time from 0 to the last quantifiable concentration
  • AUC [ Time Frame: Up to 32 weeks ]
    AUC Area Under the Curve, time from 0 to the last quantifiable concentration
  • Peak Plasma Concentration (Cmax) [ Time Frame: Up to 32 weeks ]
    Cmax Observed maximum plasma concentration
  • BRCA Diagnostic Test [ Time Frame: Samples for BRCA and HRD diagnostic testing will be obtained at screening and tested during the study. Additional biomarkers may be tested from an optional tumor sample if available at study treatment discontinuation, approximately 56months. ]
  • HRD Diagnostic Test [ Time Frame: Samples for BRCA and HRD diagnostic testing will be obtained at screening and tested during the study. Additional biomarkers may be tested from an optional tumor sample if available at study treatment discontinuation, approximately 56 months ]
 
Descriptive Information
Brief Title  ICMJE A Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Brief Summary This study is a double-blind, randomized, placebo-controlled (2:1 niraparib:placebo) study in patients with Stage III or IV ovarian cancer. Patients must have completed front-line platinum based regimen with a physician-assessed response of Complete Response (CR) or Partial Response (PR). Additionally, patients must have a normal or >90% decrease in cancer antigen 125 (CA-125) following front-line platinum treatment. The study will assess the efficacy of niraparib as maintenance treatment, as measured by PFS.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: Niraparib
    Niraparib vs Placebo 2:1 ratio
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Niraparib
    Administered once daily continuously during a 28 day cycle.
    Intervention: Drug: Niraparib
  • Placebo Comparator: Placebo
    Administered once daily continuously over a 28 day cycle
    Intervention: Drug: Placebo
Publications * González-Martín A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR, McCormick C, Lorusso D, Hoskins P, Freyer G, Baumann K, Jardon K, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Lund B, Backes F, Barretina-Ginesta P, Haggerty AF, Rubio-Pérez MJ, Shahin MS, Mangili G, Bradley WH, Bruchim I, Sun K, Malinowska IA, Li Y, Gupta D, Monk BJ; PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2019 Sep 28. doi: 10.1056/NEJMoa1910962. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2018)
620
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2016)
305
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main Inclusion Criteria:

  • Patient must have histologically confirmed, advanced (FIGO Stage III or IV) high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have completed first line platinum based chemotherapy (neoadjuvant or adjuvant)
  • Patient must have clinical complete response or partial response following completion of chemotherapy course.
  • All Stage IV patients are eligible, irrespective of residual disease, after primary or interval debulking. Stage III patients are required to have visible residual disease after primary surgery. Patients with inoperable Stage III and IV disease are eligible
  • Patient must agree to undergo central tumor HRD testing
  • Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
  • Patient must be randomized within 12 weeks of the first day of the last cycle of chemotherapy

Main Exclusion Criteria:

  • Patient has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer
  • Patient has undergone more than 2 debulking surgeries
  • Patient is to receive bevacizumab as maintenance treatment
  • Patient is pregnant, breastfeeding, or expecting to conceive children, while receiving study treatment and for 180 days after the last dose of study treatment
  • Patient has had prior treatment with a known PARP inhibitor
  • Patient has been diagnosed and/or treated for any invasive cancer (other than study disease) less than 5 years prior to study enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czechia,   Denmark,   Finland,   France,   Germany,   Hungary,   Ireland,   Israel,   Italy,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02655016
Other Study ID Numbers  ICMJE PR-30-5017-C
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tesaro, Inc.
Study Sponsor  ICMJE Tesaro, Inc.
Collaborators  ICMJE
  • Gynecologic Oncology Group
  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • Myriad Genetics, Inc.
Investigators  ICMJE Not Provided
PRS Account Tesaro, Inc.
Verification Date July 2018

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