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Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed 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: NCT03759600
Recruitment Status : Completed
First Posted : November 30, 2018
Results First Posted : August 11, 2020
Last Update Posted : January 17, 2024
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Intervention Drug: Niraparib
Enrollment 20
Recruitment Details Participants took part in the study at 17 investigative sites in Japan from 26 December 2018 to 28 December 2022.
Pre-assignment Details Female participants with a diagnosis of advanced, relapsed, high-grade serious epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4 prior lines of anti-cancer therapy and are platinum-sensitive to the last platinum-based therapy were enrolled to receive niraparib 300 mg in this study.
Arm/Group Title Niraparib 300 mg
Hide Arm/Group Description Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
Period Title: Overall Study
Started 20
Completed 0
Not Completed 20
Reason Not Completed
Adverse Event             2
Progressive Disease             15
Site Terminated by Sponsor             3
Arm/Group Title Niraparib 300 mg
Hide Arm/Group Description Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
62.4  (10.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
20
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
20
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Japan Number Analyzed 20 participants
20
 100.0%
Time from First Diagnosis to First Dose   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
4.71
(2.5 to 16.2)
[1]
Measure Description: Duration in years from the date of first diagnosis to the date of start of study drug.
Primary Tumor Site   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Ovarian
13
  65.0%
Primary Peritoneal
5
  25.0%
Fallopian Tube
2
  10.0%
[1]
Measure Description: Participant were categorized based on site of tumor are reported.
Cancer Stage (FIGO) at Time of Initial Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
IA
1
   5.0%
IC
1
   5.0%
IIB
1
   5.0%
IIC
1
   5.0%
IIIA
1
   5.0%
IIIC
12
  60.0%
IV
3
  15.0%
[1]
Measure Description: Cancer stage was based on federation of obstetrics and gynecology (FIGO) staging. Stages as I; Only in ovaries (IA: Only in endometrium, IC: Only in one or both ovaries or fallopian tubes); II: Has grown outside ovaries and is growing within pelvis (IIA: Limited to upper two-thirds of vagina, IIC: With positive peritoneal washings or ascites); III: Has spread outside pelvis into abdominal cavity or lymph nodes (IIIA: In lower third of vagina, has not grown into pelvic wall, IIIC: Larger than 2 cm on lining of abdomen and might also be in lymph nodes); IV: Has spread to other body organs.
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 20 participants
155.9  (5.78)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 20 participants
53.70  (9.701)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms per meter square (kg/m^2)
Number Analyzed 20 participants
22.12  (4.074)
[1]
Measure Description: Body Mass Index=weight (kg)/[height (m)^2]
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
0
15
  75.0%
1
5
  25.0%
[1]
Measure Description: The ECOG scale was as follows: Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Only categories with participants are reported.
Number of Prior Lines of Chemotherapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
3
12
  60.0%
4
8
  40.0%
[1]
Measure Description: Participants were categorized based on number of prior lines of chemotherapy as 3 and 4. Only categories with participants are reported.
Prior Taxane  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Participants Who Received Taxane
20
 100.0%
Prior Bevacizumab  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Participants Who Received Bevacizumab
10
  50.0%
Participants Who Did Not Receive Bevacizumab
10
  50.0%
Prior Doxorubicin  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Participants Who Received Doxorubicin
9
  45.0%
Participants Who Did Not Receive Doxorubicin
11
  55.0%
Prior Liposomal Doxorubicin  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Participants Who Did Not Receive Liposomal Doxorubicin
20
 100.0%
Prior Gemcitabine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Participants Who Received Gemcitabine
11
  55.0%
Participants Who Did Not Receive Gemcitabine
9
  45.0%
Duration between the End Date of the Last Chemotherapy Regimen and the First Dose of Study Treatment  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 20 participants
2.1
(1 to 27)
Duration between End Date of the Last Platinum-based Therapy and the First Dose of Study Treatment  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 20 participants
16.3
(1 to 36)
Prior Surgery/Procedure for Study Indication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Participants Who Had Prior Surgery
20
 100.0%
Number of Prior Surgery/Procedure for Study Indication  
Mean (Standard Deviation)
Unit of measure:  Surgery
Number Analyzed 20 participants
2.3  (1.34)
Prior Radiation Therapy Related to the Study Indication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Had Radiation Therapy
2
  10.0%
Had No Radiation Therapy
18
  90.0%
Response to Last Platinum-based Therapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Complete Response (CR)
9
  45.0%
Partial Response (PR)
8
  40.0%
Stable Disease (SD)
2
  10.0%
Unknown
1
   5.0%
[1]
Measure Description: Response to last platinum-based therapy achieving complete response(CR), partial response(PR), progressive disease(PD) or Stable Disease(SD) per response evaluation criteria in solid tumors version 1.1(RECIST v.1.1) CR=disappearance of all target lesions and PR=atleast a 30% decrease in sum of diameters (SoD) of target lesions, taking as reference baseline SoD. PD=at least a 20% increase in SoD of target lesions, taking as reference smallest (nadir) SoD since (and including) baseline. SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time to Progression after the Last Platinum Therapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
6-12 Month
12
  60.0%
More Than 12 Month
8
  40.0%
[1]
Measure Description: Participants with time to progression were categorized as 6-12 months and more than 12 months. Time to progression is defined as the time from the date of last administration of platinum therapy to the first documentation of disease progression.
Ovarian Cancer Pathology Histological: Histologic Subtype   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Serous
20
 100.0%
Endometrioid
0
   0.0%
Mucinous
0
   0.0%
Other
0
   0.0%
[1]
Measure Description: Participants were categorized as serous, endometrioid, mucinous and other for histological subtype of ovarian cancer pathology.
Ovarian Cancer Pathology Histological: Tumor Grade   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Grade 2
1
   5.0%
Grade 3
6
  30.0%
High Grade
13
  65.0%
[1]
Measure Description: With regard to tumor grading, conventional FIGO/ gynecologic oncology group (GOG)/ world health organisation (WHO) criteria or two-tier system for grading ovarian serous carcinoma is used; participants with grade 3 tumors in FIGO/GOG/WHO criteria (among grade 1 as well differentiated, grade 2 as moderately differentiated, and grade 3 indicates poorly differentiated) or participants with high-grade tumors in two-tier system (among low-grade or high-grade) are reported.
Germline Breast Cancer (Gene) (BRCA1) Mutant   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Without Mutant
3
  15.0%
Unknown
17
  85.0%
[1]
Measure Description: Participants were categorized as positive, negative or unknown for mutation of BRCA1 gene. Only categories with participants are reported.
Germline BRCA2 Mutant   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Without Mutant
3
  15.0%
Unknown
17
  85.0%
[1]
Measure Description: Participants were categorized as positive, negative or unknown for mutation of BRCA2 gene. Only categories with participants are reported.
Homologous Recombination Deficiency/Deficient (HRD) Companion Diagnostic (CDx) Test Result   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Positive
20
 100.0%
[1]
Measure Description: Participants were categorized as positive, negative and unknown for HRD CDx test result. Only categories with participants are reported.
Genomic Instability Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Positive
17
  85.0%
Unknown
3
  15.0%
[1]
Measure Description: Participants were categorized as positive, negative and unknown for genomic instability status. Only categories with participants are reported.
Tumor BRCA1/BRCA2 Mutation Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Negative
6
  30.0%
Positive
13
  65.0%
Unknown
1
   5.0%
[1]
Measure Description: Participants were categorized as positive, negative and unknown for BRCA1/BRCA2 mutation status.
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants achieving CR or PR as assessed by the Investigator per RECIST v.1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the Baseline SoD.
Time Frame Until disease progression or death (Up to 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.
Arm/Group Title Niraparib 300 mg
Hide Arm/Group Description:
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
60.0
2.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was defined as the time from the first documented CR or PR per RECIST v.1.1 to disease recurrence or objective disease progression whichever occurs first. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the Baseline SoD.
Time Frame Until disease progression or death (Up to 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline. Only Responders were analyzed for this outcome measure.
Arm/Group Title Niraparib 300 mg
Hide Arm/Group Description:
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
Overall Number of Participants Analyzed 12
Median (95% Confidence Interval)
Unit of Measure: months
9.9 [1] 
(3.9 to NA)
[1]
Upper limit of 95% confidence interval (CI) was not estimable due to low number of participants with events.
3.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description DCR was defined as the percentage of participants achieving CR, PR or SD as assessed by the Investigator per RECIST v.1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the Baseline SoD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline.
Time Frame Until disease progression or death (Up to 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.
Arm/Group Title Niraparib 300 mg
Hide Arm/Group Description:
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90.0
(68.302 to 98.765)
4.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of study drug.
Arm/Group Title Niraparib 300 mg
Hide Arm/Group Description:
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
20
 100.0%
5.Secondary Outcome
Title Number of Participants With Grade 3 or Higher TEAEs
Hide Description An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug. A severity grade was defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
Time Frame From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of study drug.
Arm/Group Title Niraparib 300 mg
Hide Arm/Group Description:
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
17
  85.0%
6.Secondary Outcome
Title Number of Participants With Serious TEAEs
Hide Description An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of study drug.
Arm/Group Title Niraparib 300 mg
Hide Arm/Group Description:
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
8
  40.0%
7.Secondary Outcome
Title Number of Participants With TEAEs Leading to Drug Discontinuation
Hide Description An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of study drug.
Arm/Group Title Niraparib 300 mg
Hide Arm/Group Description:
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
2
  10.0%
8.Secondary Outcome
Title Number of Participants With TEAEs Leading to Dose Interruption
Hide Description An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of study drug.
Arm/Group Title Niraparib 300 mg
Hide Arm/Group Description:
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
15
  75.0%
9.Secondary Outcome
Title Number of Participants With TEAEs Leading to Dose Reduction
Hide Description An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of study drug.
Arm/Group Title Niraparib 300 mg
Hide Arm/Group Description:
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
16
  80.0%
10.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the time in months from the date of first study drug administration to the date of first documentation of PD or death as assessed by the RECIST v.1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline.
Time Frame Until disease progression or death (Up to 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.
Arm/Group Title Niraparib 300 mg
Hide Arm/Group Description:
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: months
8.3
(5.6 to 13.8)
11.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time in months from the study enrollment to death due to any cause.
Time Frame From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.
Arm/Group Title Niraparib 300 mg
Hide Arm/Group Description:
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: months
24.9 [1] 
(14.9 to NA)
[1]
Upper limit of 95% CI was not estimable due to low number of participants with events.
Time Frame From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Niraparib 300mg
Hide Arm/Group Description Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
All-Cause Mortality
Niraparib 300mg
Affected / at Risk (%)
Total   13/20 (65.00%) 
Hide Serious Adverse Events
Niraparib 300mg
Affected / at Risk (%)
Total   8/20 (40.00%) 
Blood and lymphatic system disorders   
Anaemia † 1  2/20 (10.00%) 
Gastrointestinal disorders   
Ascites † 1  1/20 (5.00%) 
Ileus † 1  1/20 (5.00%) 
Intestinal obstruction † 1  1/20 (5.00%) 
Investigations   
Platelet count decreased † 1  2/20 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Parathyroid tumour benign † 1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea † 1  1/20 (5.00%) 
Vascular disorders   
Embolism † 1  1/20 (5.00%) 
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Niraparib 300mg
Affected / at Risk (%)
Total   20/20 (100.00%) 
Blood and lymphatic system disorders   
Anaemia † 1  14/20 (70.00%) 
Cardiac disorders   
Palpitations † 1  4/20 (20.00%) 
Gastrointestinal disorders   
Constipation † 1  9/20 (45.00%) 
Nausea † 1  12/20 (60.00%) 
Stomatitis † 1  5/20 (25.00%) 
Vomiting † 1  8/20 (40.00%) 
General disorders   
Malaise † 1  6/20 (30.00%) 
Infections and infestations   
Nasopharyngitis † 1  3/20 (15.00%) 
Investigations   
Alanine aminotransferase increased † 1  2/20 (10.00%) 
Aspartate aminotransferase increased † 1  2/20 (10.00%) 
Blood alkaline phosphatase increased † 1  2/20 (10.00%) 
Blood creatinine increased † 1  4/20 (20.00%) 
Gamma-glutamyltransferase increased † 1  2/20 (10.00%) 
Lymphocyte count decreased † 1  2/20 (10.00%) 
Neutrophil count decreased † 1  6/20 (30.00%) 
Platelet count decreased † 1  10/20 (50.00%) 
Weight decreased † 1  4/20 (20.00%) 
White blood cell count decreased † 1  6/20 (30.00%) 
Metabolism and nutrition disorders   
Decreased appetite † 1  5/20 (25.00%) 
Musculoskeletal and connective tissue disorders   
Back pain † 1  2/20 (10.00%) 
Musculoskeletal pain † 1  2/20 (10.00%) 
Nervous system disorders   
Dizziness † 1  3/20 (15.00%) 
Dysgeusia † 1  4/20 (20.00%) 
Headache † 1  7/20 (35.00%) 
Neuropathy peripheral † 1  2/20 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis † 1  4/20 (20.00%) 
Oropharyngeal pain † 1  3/20 (15.00%) 
Skin and subcutaneous tissue disorders   
Alopecia † 1  3/20 (15.00%) 
Pruritus † 1  2/20 (10.00%) 
Rash † 1  3/20 (15.00%) 
Vascular disorders   
Hypertension † 1  6/20 (30.00%) 
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
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Name/Title: Study Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: TrialDisclosures@takeda.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03759600    
Other Study ID Numbers: Niraparib-2002
U1111-1222-4100 ( Other Identifier: WHO )
JapicCTI-184224 ( Registry Identifier: JapicCTI )
First Submitted: November 29, 2018
First Posted: November 30, 2018
Results First Submitted: June 30, 2020
Results First Posted: August 11, 2020
Last Update Posted: January 17, 2024