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

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: NCT01847274
Recruitment Status : Active, not recruiting
First Posted : May 6, 2013
Results First Posted : May 1, 2019
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Myriad Genetics, Inc.
US Oncology Research
Sarah Cannon
Cooperative Ovarian Cancer Group (COGI)
Facing Our Risk of Cancer Empowered
Information provided by (Responsible Party):
Tesaro, Inc.

Tracking Information
First Submitted Date  ICMJE April 11, 2013
First Posted Date  ICMJE May 6, 2013
Results First Submitted Date  ICMJE October 18, 2018
Results First Posted Date  ICMJE May 1, 2019
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE June 21, 2013
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • Progression-Free Survival (PFS) in Cohort With Germline BRCA Mutation (gBRCA) [ Time Frame: From date of randomization to the earliest date of disease progression or death from any cause. ]
    PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion.
  • Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+) [ Time Frame: From date of randomization to the earliest date of disease progression or death from any cause ]
    PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion.
  • Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation (Non-gBRCA) [ Time Frame: From date of randomization to the earliest date of disease progression or death from any cause. ]
    PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion.
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
Progression free survival of ovarian cancer patients [ Time Frame: 35 months ]
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2020)
  • Time to First Subsequent Therapy (TFST) in Cohort With Germline BRCA Mutation (gBRCA) [ Time Frame: From date of randomization to the earliest date of first subsequent therapy or death. ]
    Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment. The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death.
  • Time to First Subsequent Therapy (TFST) in Cohort With No Germline BRCA Mutation (Non-gBRCA) [ Time Frame: From date of randomization to the earliest date of first subsequent therapy or death. ]
    Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment. The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death.
  • Chemotherapy-Free Interval (CFI) in Cohort With Germline BRCA Mutation (gBRCA) [ Time Frame: From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment. ]
    CFI was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment.
  • Chemotherapy-Free Interval (CFI) in Cohort With No Germline BRCA Mutation (Non-gBRCA) [ Time Frame: From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment. ]
    CFI was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment.
  • Progression-Free Survival 2 (PFS2) in Cohort With Germline BRCA Mutation (gBRCA) [ Time Frame: From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause. ]
    Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. PFS2 was defined as the time from treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause. This study is ongoing, PFS2 is immature at this stage of primary analysis.
  • Progression-Free Survival 2 (PFS2) in Cohort With No Germline BRCA Mutation (Non-gBRCA) [ Time Frame: From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause. ]
    Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. PFS2 was defined as the time from treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause. This study is ongoing, PFS2 is immature at this stage of primary analysis.
  • Overall Survival (OS) in Cohort With Germline BRCA Mutation (gBRCA) [ Time Frame: From treatment randomization to date of death by any cause ]
    Patients were to be followed off treatment every 3 months for survival status. Overall survival is defined as the date of randomization to the date of death by any cause. Results not yet reported.
  • Overall Survival (OS) in Cohort With No Germline BRCA Mutation (Non-gBRCA) [ Time Frame: From treatment randomization to date of death by any cause ]
    Patients were to be followed off treatment every 3 months for survival status. Overall survival is defined as the date of randomization to the date of death by any cause. Results not yet reported.
  • Time to Second Subsequent Therapy (TSST) in Cohort With Germline BRCA Mutation (gBRCA) [ Time Frame: From the date of randomization to the start date of the second subsequent anti-cancer therapy. ]
    Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. TSST is defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death. Results not yet reported.
  • Time to Second Subsequent Therapy (TSST) in Cohort With No Germline BRCA Mutation (Non-gBRCA) [ Time Frame: From the date of randomization to the start date of the second subsequent anti-cancer therapy. ]
    Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. TSST is defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death. Results not yet reported.
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA [ Time Frame: At Cycle 2 ]
    The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA [ Time Frame: At Cycle 4 ]
    The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA [ Time Frame: At Cycle 6 ]
    The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA [ Time Frame: At Post Progression ]
    The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA [ Time Frame: At Cycle 2 ]
    The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA [ Time Frame: At Cycle 4 ]
    The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA [ Time Frame: At Cycle 6 ]
    The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
  • Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA [ Time Frame: At Post Progression ]
    The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from baseline indicates improvement.
  • Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA [ Time Frame: At Cycle 2 ]
    EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
  • Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA [ Time Frame: At Cycle 4 ]
    EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
  • Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA [ Time Frame: At Cycle 6 ]
    EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
  • Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA [ Time Frame: At Post Progression ]
    EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
  • Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA [ Time Frame: At Cycle 2 ]
    EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
  • Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA [ Time Frame: At Cycle 4 ]
    EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
  • Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA [ Time Frame: At Cycle 6 ]
    EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
  • Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA [ Time Frame: At Post Progression ]
    EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
  • Patient Reported Outcomes [ Time Frame: 35 months ]
    Functional Assessment of Cancer therapy - Ovarian Symptom Index (FOSI) EQ-5D-5L Neuropathy Questionnaire
  • Progression Free Survival Two [ Time Frame: 35 months ]
    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 ]
    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 ]
  • Evaluate the safety and tolerability of niraparib in ovarian cancer patients [ Time Frame: 35 months ]
    Review of adverse events, physical exams, electrocardiograms (ECGs), and safety lab values
  • BRACA diagnostic test [ Time Frame: 35 months ]
    Concordance of a candidate companion diagnostic test compared to centralized BRCA mutation test
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
Official Title  ICMJE A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
Brief Summary

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).

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 Neoplasms
  • Platinum Sensitive Ovarian Cancer
Intervention  ICMJE
  • Drug: Active comparator: Niraparib
    Niraparib vs placebo 2:1 ratio
    Other Name: Niraparib
  • Drug: placebo
Study Arms  ICMJE
  • Active Comparator: Niraparib
    2:1 Ratio administered once daily continuously during a 28 day cycle.
    Intervention: Drug: Active comparator: Niraparib
  • Placebo Comparator: Placebo
    Administered once daily continuously over a 28 day cycle.
    Intervention: Drug: placebo
Publications *

*   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
Actual Enrollment  ICMJE
 (submitted: April 10, 2019)
553
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2013)
360
Estimated Study Completion Date  ICMJE December 14, 2020
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Hungary,   Israel,   Italy,   Norway,   Poland,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01847274
Other Study ID Numbers  ICMJE 213356
PR-30-5011-C ( Other Identifier: Tesaro )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tesaro, Inc.
Study Sponsor  ICMJE Tesaro, Inc.
Collaborators  ICMJE
  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • Myriad Genetics, Inc.
  • US Oncology Research
  • Sarah Cannon
  • Cooperative Ovarian Cancer Group (COGI)
  • Facing Our Risk of Cancer Empowered
Investigators  ICMJE
Study Director: GSK Clinical Studies GlaxoSmithKline
PRS Account Tesaro, Inc.
Verification Date May 2020

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