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

This study is ongoing, but not recruiting participants.
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: April 23, 2015
Last verified: April 2015
  Purpose

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 Intervention Phase
Platinum Sensitive Ovarian Cancer
Drug: Active comparator: Niraparib
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Tesaro, Inc.:

Primary Outcome Measures:
  • 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). In the non-gBRCAmut cohort, PFS will be hierarchically evaluated first in HRD+ patients and then in all non-gBRCAmut patients.


Secondary Outcome Measures:
  • 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

  • HRD diagnostic test [ Time Frame: 35 months ] [ Designated as safety issue: No ]
    Concordance of a candidate companion HRD diagnostic test compared to centralized HRD test


Estimated Enrollment: 490
Study Start Date: June 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847274

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, California
La Jolla, California, United States
Los Angeles, California, United States
Orange, California, United States
San Francisco, California, United States
Stanford, California, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Florida
Sarasota, Florida, United States
Tampa, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
United States, Minnesota
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
United States, New Jersey
Morristown, New Jersey, United States
United States, New Mexico
Farmington, New Mexico, United States
United States, New York
New Hyde Park, New York, United States
New York, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Abington, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
Providence, Rhode Island, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
United States, Washington
Vancouver, Washington, United States
Austria
Graz, Austria
Innsbruck, Austria
Wien, Austria
Belgium
Edegem, Antwerpen, Belgium
Leuven, Vlaams Brabant, Belgium
Kortrijk, Belgium
Liège, Belgium
Canada, Alberta
Calgary, Alberta, Canada
Canada, British Columbia
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Canada, Ontario
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Denmark
Aalborg, Denmark
Copenhagen, Denmark
Herlev, Denmark
Odense, Denmark
France
Besancon, France
Lille, France
Montpellier, France
Nice, France
St Brieuc, France
St Herblain Cedex, France
Strasbourg, France
Germany
Dresden, Sachsen, Germany
Berlin, Germany
Düsseldorf, Germany
Essen, Germany
Göttingen, Germany
Hamburg, Germany
Hannover, Germany
Heidelberg, Germany
Kiel, Germany
München, Germany
Ulm, Germany
Hungary
Budapest, Hungary
Miskolc, Hungary
Szolnok, Hungary
Israel
Rehovot, HaMerkaz, Israel
Haifa, Hefa, Israel
Holon, Israel
Jerusalem, Israel
Kefar-Saba, Israel
Tel Aviv, Israel
Tel Hashomer, Israel
Italy
Monza, Lombardia, Italy
Aviano, Italy
Brescia, Italy
Catania, Italy
Milano, Italy
Pisa, Italy
Roma, Italy
Norway
Bergen, Norway
Oslo, Norway
Poland
Bialystok, Podlaskie, Poland
Gdansk, Pomorskie, Poland
Gdansk, Poland
Lodz, Poland
Poznan, Poland
Spain
Oviedo, Asturias, Spain
Barcelona, Spain
Madrid, Spain
Palma de Mallorca, Spain
Sweden
Linkoeping, Sweden
Lund, Sweden
Stockholm, Sweden
United Kingdom
Bangor, Gwynedd, United Kingdom
Birmingham, United Kingdom
Kent, United Kingdom
London, United Kingdom
Nottingham, United Kingdom
Somerset, United Kingdom
Wirral, United Kingdom
Sponsors and Collaborators
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)
Investigators
Principal Investigator: Mansoor Raza Mirza, MD Rigshospitalet, Denmark
Principal Investigator: Ursula Matulonis, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT01847274     History of Changes
Other Study ID Numbers: PR-30-5011-C
Study First Received: April 11, 2013
Last Updated: April 23, 2015
Health Authority: United States: Food and Drug Administration
EU: EMEA

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on July 30, 2015