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

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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.

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Niraparib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 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, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Study Start Date : April 2016
Estimated Primary Completion Date : February 2020


Arm Intervention/treatment
Experimental: Niraparib
Administered once daily continuously during a 28 day cycle.
Drug: Niraparib
Niraparib vs Placebo 2:1 ratio

Placebo Comparator: Placebo
Administered once daily continuously over a 28 day cycle
Drug: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Patient Reported Outcomes (PROs) [ Time Frame: 48 months ]
  4. 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.


Other Outcome Measures:
  1. AUC0-last [ Time Frame: Up to 32 weeks ]
    AUC Area Under the Curve, time from 0 to the last quantifiable concentration

  2. AUC [ Time Frame: Up to 32 weeks ]
    AUC Area Under the Curve, time from 0 to the last quantifiable concentration

  3. Peak Plasma Concentration (Cmax) [ Time Frame: Up to 32 weeks ]
    Cmax Observed maximum plasma concentration

  4. 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 ]


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

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.

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): NCT02655016


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Locations
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United States, Arizona
Chandler, Arizona, United States
Tucson, Arizona, United States
United States, California
Los Angeles, California, United States
San Francisco, California, United States
Santa Rosa, California, United States
United States, Connecticut
Hartford, Connecticut, United States
New Haven, Connecticut, United States
United States, Florida
Hollywood, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
Gainesville, Georgia, United States
Savannah, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Geneva, Illinois, United States
Hinsdale, Illinois, United States
Maywood, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
Munster, Indiana, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Louisiana
Baton Rouge, Louisiana, United States
Covington, Louisiana, United States
New Orleans, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
Rockville, Maryland, United States
United States, Massachusetts
Burlington, Massachusetts, United States
Springfield, Massachusetts, United States
United States, Michigan
Grand Rapids, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
Springfield, Missouri, United States
United States, New Jersey
Neptune, New Jersey, United States
Teaneck, New Jersey, United States
United States, New York
Brooklyn, New York, United States
Buffalo, New York, United States
Mineola, New York, United States
New York, New York, United States
Rochester, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
Wilmington, North Carolina, United States
United States, Ohio
Canton, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Kettering, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
Springfield, Oregon, United States
United States, Pennsylvania
Abington, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, Rhode Island
Providence, Rhode Island, United States
United States, South Carolina
Charleston, South Carolina, United States
Greenville, South Carolina, United States
United States, South Dakota
Sioux Falls, South Dakota, United States
United States, Texas
Arlington, Texas, United States
Austin, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
Tyler, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Chesapeake, Virginia, United States
United States, Washington
Kennewick, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
United States, West Virginia
Morgantown, West Virginia, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Belgium
Bonheiden, Belgium
Brussels, Belgium
Bruxelles, Belgium
Charleroi, Belgium
Gent, Belgium
Hasselt, Belgium
Leuven, Belgium
Libramont, Belgium
Namur, Belgium
Sint-Niklaas, Belgium
Canada, Alberta
Calgary, Alberta, Canada
Canada, British Columbia
Kelowna, British Columbia, Canada
Surrey, British Columbia, Canada
Vancouver, British Columbia, Canada
Canada, Ontario
Barrie, Ontario, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Greenfield Park, Quebec, Canada
Montreal, Quebec, Canada
Czechia
Ostrava, Czechia
Plzen, Czechia
Prague, Czechia
Denmark
Aalborg, Denmark
Copenhagen, Denmark
Herlev, Denmark
Odense, Denmark
Finland
Kuopio, Finland
Oulu, Finland
Tampere, Finland
Turku, Finland
France
Angers, France
Caen, France
Lyon, France
Montpellier, France
Nice, France
Paris, France
Rennes, France
Saint-Herblain, France
Germany
Aachen, Germany
Berlin, Germany
Dresden, Germany
Essen, Germany
Frankfurt, Germany
Fuerth, Germany
Göttingen, Germany
Hamburg, Germany
Heidelberg, Germany
Hildesheim, Germany
Karlsruhe, Germany
Ludwigshafen, Germany
Mannheim, Germany
München, Germany
Schwäbisch Hall, Germany
Hungary
Budapest, Hungary
Debrecen, Hungary
Gyor, Hungary
Szolnok, Hungary
Ireland
Cork, Ireland
Dublin, Ireland
Galway, Ireland
Waterford, Ireland
Israel
Be'er Sheva, Israel
Haifa, Israel
HaShomer, Israel
Holon, Israel
Petah Tikva, Israel
Tel Aviv, Israel
Italy
Lecce, Italy
Meldola, Italy
Milan, Italy
Mirano, Italy
Modena, Italy
Napoli, Italy
Torino, Italy
Norway
Bergen, Norway
Oslo, Norway
Poland
Lodz, Poland
Lublin, Poland
Olsztyn, Poland
Poznań, Poland
Russian Federation
Arkhangel'sk, Russian Federation
Chelyabinsk, Russian Federation
Irkutsk, Russian Federation
Ivanovo, Russian Federation
Kazan, Russian Federation
Krasnoyarsk, Russian Federation
Kursk, Russian Federation
Novosibirsk, Russian Federation
Orenburg, Russian Federation
Pyatigorsk, Russian Federation
Saint Petersburg, Russian Federation
Samara, Russian Federation
Spain
Alicante, Spain
Barcelona, Spain
Córdoba, Spain
Girona, Spain
Madrid, Spain
San Sebastian, Spain
Sevilla, Spain
Valencia, Spain
Zaragoza, Spain
Sweden
Stockholm, Sweden
Uppsala, Sweden
Switzerland
Basel, Switzerland
Bern, Switzerland
Frauenfeld, Switzerland
Zurich, Switzerland
Ukraine
Chernivtsi, Ukraine
Dnipro, Ukraine
Ivano-Frankivsk, Ukraine
Kharkiv, Ukraine
Kherson, Ukraine
Kryvyi Rih, Ukraine
Odessa, Ukraine
Uzhgorod, Ukraine
Vinnytsya, Ukraine
Zaporizhzhya, Ukraine
United Kingdom
Bath, United Kingdom
Blackburn, United Kingdom
Edinburgh, United Kingdom
Exeter, United Kingdom
London, United Kingdom
Portsmouth, United Kingdom
Sheffield, United Kingdom
Staffordshire, United Kingdom
Truro, United Kingdom
Sponsors and Collaborators
Tesaro, Inc.
Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Myriad Genetics, Inc.

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Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT02655016     History of Changes
Other Study ID Numbers: PR-30-5017-C
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Keywords provided by Tesaro, Inc.:
Ovarian Cancer
PARP Inhibitor
HRD
HRD positive
PRIMA
PRIMA Clinical Trial
PRIMA Study

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