Trial record 5 of 663 for:    ovarian cancer | Open Studies

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

This study is currently recruiting participants.
Verified April 2014 by Tesaro, Inc.
Sponsor:
Collaborators:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
FORCE Facing our Risk of Cancer Empowered
Information provided by (Responsible Party):
Tesaro, Inc.
ClinicalTrials.gov Identifier:
NCT01847274
First received: April 11, 2013
Last updated: April 2, 2014
Last verified: April 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 response 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01847274

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

  Show 62 Study Locations
Sponsors and Collaborators
Tesaro, Inc.
European Network of Gynaecological Oncological Trial Groups (ENGOT)
FORCE Facing our Risk of Cancer Empowered
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 2, 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
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 17, 2014