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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: October 21, 2014
Last verified: September 2014
  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).


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


Estimated Enrollment: 360
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

Contacts
Contact: Shefali Agarwal, MD 781-916-8375 Sagarwal@tesarobio.com

  Hide Study Locations
Locations
United States, Arizona
Recruiting
Phoenix, Arizona, United States
Recruiting
Tucson, Arizona, United States
United States, California
Recruiting
La Jolla, California, United States
Recruiting
Los Angeles, California, United States
Recruiting
Orange, California, United States
Recruiting
San Francisco, California, United States
Recruiting
Stanford, California, United States
United States, Connecticut
Recruiting
New Haven, Connecticut, United States
United States, Florida
Recruiting
Sarasota, Florida, United States
Recruiting
Tampa, Florida, United States
United States, Georgia
Recruiting
Atlanta, Georgia, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
United States, Indiana
Recruiting
Indianapolis, Indiana, United States
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
Recruiting
Burlington, Massachusetts, United States
United States, Minnesota
Recruiting
Minneapolis, Minnesota, United States
Recruiting
Rochester, Minnesota, United States
United States, New Jersey
Recruiting
Morristown, New Jersey, United States
United States, New Mexico
Recruiting
Farmington, New Mexico, United States
United States, New York
Recruiting
New Hyde Park, New York, United States
Recruiting
New York, New York, United States
United States, North Carolina
Recruiting
Durham, North Carolina, United States
Recruiting
Winston-Salem, North Carolina, United States
United States, Ohio
Withdrawn
Toledo, Ohio, United States
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Recruiting
Abington, Pennsylvania, United States
Recruiting
Philadelphia, Pennsylvania, United States
United States, Rhode Island
Recruiting
Providence, Rhode Island, United States
United States, Tennessee
Recruiting
Nashville, Tennessee, United States
United States, Texas
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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San Antonio, Texas, United States
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The Woodlands, Texas, United States
United States, Washington
Recruiting
Vancouver, Washington, United States
Austria
Recruiting
Graz, Austria
Recruiting
Innsbruck, Austria
Recruiting
Wien, Austria
Belgium
Recruiting
Edegem, Antwerpen, Belgium
Recruiting
Leuven, Vlaams Brabant, Belgium
Recruiting
Kortrijk, Belgium
Recruiting
Liège, Belgium
Canada, Alberta
Recruiting
Calgary, Alberta, Canada
Canada, British Columbia
Recruiting
Kelowna, British Columbia, Canada
Recruiting
Vancouver, British Columbia, Canada
Canada, Ontario
Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Recruiting
Montreal, Quebec, Canada
Recruiting
Sherbrooke, Quebec, Canada
Denmark
Recruiting
Aalborg, Denmark
Recruiting
Copenhagen, Denmark
Recruiting
Herlev, Denmark
Recruiting
Odense, Denmark
France
Recruiting
Besancon, France
Recruiting
Lille, France
Recruiting
Montpellier, France
Recruiting
Nice, France
Recruiting
St Brieuc, France
Recruiting
St Herblain Cedex, France
Recruiting
Strasbourg, France
Germany
Recruiting
Dresden, Sachsen, Germany
Recruiting
Berlin, Germany
Recruiting
Düsseldorf, Germany
Recruiting
Essen, Germany
Recruiting
Göttingen, Germany
Recruiting
Hamburg, Germany
Recruiting
Hannover, Germany
Recruiting
Heidelberg, Germany
Recruiting
Kiel, Germany
Recruiting
München, Germany
Recruiting
Ulm, Germany
Hungary
Recruiting
Budapest, Hungary
Recruiting
Miskolc, Hungary
Recruiting
Szolnok, Hungary
Israel
Recruiting
Rehovot, HaMerkaz, Israel
Recruiting
Haifa, Hefa, Israel
Recruiting
Jerusalem, Israel
Recruiting
Kefar-Saba, Israel
Recruiting
Tel Aviv, Israel
Recruiting
Tel Hashomer, Israel
Italy
Recruiting
Milano, Italy
Recruiting
Pisa, Italy
Recruiting
Roma, Italy
Norway
Recruiting
Bergen, Norway
Recruiting
Oslo, Norway
Poland
Recruiting
Bialystok, Podlaskie, Poland
Recruiting
Gdansk, Pomorskie, Poland
Recruiting
Gdansk, Poland
Recruiting
Lodz, Poland
Recruiting
Poznan, Poland
Spain
Recruiting
Oviedo, Asturias, Spain
Recruiting
Barcelona, Spain
Recruiting
Madrid, Spain
Recruiting
Palma de Mallorca, Spain
Sweden
Recruiting
Linkoeping, Sweden
Recruiting
Lund, Sweden
Recruiting
Stockholm, Sweden
United Kingdom
Recruiting
Bangor, Gwynedd, United Kingdom
Recruiting
Birmingham, United Kingdom
Recruiting
Kent, United Kingdom
Recruiting
London, United Kingdom
Recruiting
Nottingham, United Kingdom
Recruiting
Somerset, United Kingdom
Recruiting
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: October 21, 2014
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 November 20, 2014