TOPACIO: Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer

Sponsor
Tesaro, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02657889
Collaborator
Merck Sharp & Dohme Corp. (Industry)
122
Enrollment
30
Locations
1
Arm
65.1
Actual Duration (Months)
4.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. (KEYNOTE-162)

Study Design

Study Type:
Interventional
Actual Enrollment :
122 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1/2 Clinical Study of Niraparib in Combination With Pembrolizumab (MK-3475) in Patients With Advanced or Metastatic Triple-Negative Breast Cancer and in Patients With Recurrent Ovarian Cancer
Actual Study Start Date :
Apr 15, 2016
Actual Primary Completion Date :
May 14, 2018
Actual Study Completion Date :
Sep 17, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: niraparib plus pembrolizumab

Phase 1: Dose-escalation: ascending doses of niraparib up to 300mg/day orally (PO) on Days 1-21 and pembrolizumab 200mg intravenously (IV) on Day 1 of each 21-day cycle Phase 2: niraparib (recommended Phase 2 dose) in combination with pembrolizumab 200mg IV on Day 1 of each 21-day cycle

Drug: niraparib

Biological: pembrolizumab

Outcome Measures

Primary Outcome Measures

  1. Phase 1: Number of Subjects Reporting Dose-Limiting Toxicities (DLTs) [During Cycle 1, ie, during the first 21 days of treatment]

    DLTs are defined as: Any treatment-related Grade ≥ 3 non-hematologic clinical (non-laboratory) AE Any treatment-related Grade 3 or Grade 4 non-hematologic lab abnormality if: - Medical intervention is required to treat the patient, or - The abnormality leads to hospitalization, or - The abnormality persists for ≥ 7 days. Any treatment-related hematologic toxicity specifically defined as: - Thrombocytopenia Grade 4 for ≥ 7 days, or Grade 3 or 4 associated with bleeding or requiring platelet transfusion; - Neutropenia Grade 4 for ≥ 7 days, or Grade 3 or 4 associated with infection or febrile neutropenia; - Anemia Grade 4, or Grade 3 or 4 requiring blood transfusion. Any treatment-related AE leading to niraparib dose interruption per the following criteria: - A dose interruption for a non-DLT lab abnormality lasting ≥ 14 days. - A dose in interruption per dose modification rules for nonhematologic AE leading to < 80% of an intended dose being administered.

  2. Phase 2: Objective Response Rate (ORR) [Up to 40 weeks]

    ORR is defined as the percentage of patients who achieved a best overall response of Complete Response (CR) or Partial Response (PR), per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by the Investigator: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Secondary Outcome Measures

  1. To Evaluate the Safety and Tolerability of Combination Treatment With Niraparib and Pembrolizumab Using Common Terminology Criteria for Adverse Events (CTCAE, v4.03) [AEs were collected up to 90 days following the last dose of study treatment, where the median duration of treatment was 3 months.]

    Percentage of patients with at least 1 Treatment-Emergent Adverse Event. Refer to the adverse event tables for specific details.

  2. Phase 2: Overall Response Rate (ORR) as Measured by Immune-related RECIST (irRECIST) [Radiographic evaluations were conducted every 9 weeks while on study treatment (every 12 weeks after 1 year of scans) independent of cycle delays and/or dose interruptions, and/or at any time when progression of disease is suspected.]

    ORR by irRECIST is defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR) using immune-related RECIST criteria.

  3. Phase 2: Duration of Response (DOR) [From first documentation of response (CR or PR) using RECIST (v1.1) as assessed by the Investigator until time of first documented progression.]

    From first documentation of response (CR or PR) using RECIST (v1.1) as assessed by the investigator until time of first documented progression or death by any cause. No maximum timeframe was specified in the protocol.

  4. Phase 2: Disease Control Rate (DCR) [Up to 40 weeks]

    DCR is defined as the percentage of patients who achieved a CR or PR or stable disease (SD) using RECIST (v1.1) as assessed by the Investigator.

  5. Phase 2: Progression Free Survival (PFS) [From date of first dose to the earlier date of assessment of progression of death by any cause in the absence of progression.]

    From date of first dose to the earlier date of assessment of progression or death by any cause in the absence of progression. No maximum timeframe was specified in the protocol.

  6. Phase 2: Overall Survival (OS) [From date of first dose to the date of death by any cause.]

    Patients were followed off treatment every 90 days for survival status. Overall survival is defined as the time from first dose to the date of death by any cause. No maximum timeframe was specified in the protocol.

  7. Phase 1 and Phase 2: To Evaluate the Pharmacokinetics (PK) of Niraparib and Associated Major Metabolite M1 During Combination Treatment. [Approximately 9 months]

    Area Under the Curve (AUC), Minimum Concentration (Cmin), Maximum Concentration (Cmax), Clearance After Oral Administration (CL/F), Volume of Distribution After Oral Administration (Vz/F), AUC at Steady State (AUCss), Cmin at Steady State (Cmin,ss), Cmax at Steady State (Cmax,ss).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Main Inclusion Criteria:
  • Patient has histologically proven advanced (unresectable) or metastatic cancer as outlined below according to study phase and disease type:
  1. Phase 1 patients (breast or ovarian cancer)
  • Patients with advanced or metastatic breast cancer must have disease that is HER2-negative, estrogen receptor-negative, and progesterone receptor-negative (ie, TNBC). Patients with advanced or metastatic disease may have up to 4 lines of cytotoxic therapy. Neoadjuvant and adjuvant therapies are not counted towards lines of therapy.

  • Patients must have any epithelial (ie, serous, endometroid, mucinous, clear cell) ovarian, fallopian tube, or primary peritoneal cancer. Patients must have experienced a response lasting at least 6 months to first-line platinum-based therapy but currently considered to have platinum-resistant disease per investigator's assessment (e.g, patient is not eligible for further platinum containing treatment). Patients may have received up to 5 lines of cytotoxic therapy for advanced or metastatic cancer. Neoadjuvant and adjuvant therapies are not counted towards lines of therapy.

  1. Phase 2 patients (breast or ovarian cancer)
  • Patients with advanced or metastatic breast cancer must have TNBC. Patients with advanced or metastatic disease may have received up to 2 lines of cytotoxic therapy. Adjuvant and/or neoadjuvant therapies are not counted in the number of lines of therapy. TNBC patients who have previously received platinum chemotherapy in the metastatic setting are allowed to enroll in the study as long as they did not progress while on or within 8 weeks from the day of the last platinum administration.

  • Patients must have with high-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer. Patients must have experienced a response lasting at least 6 months to first-line platinum-based therapy but currently considered to have platinum-resistant disease per investigator's assessment (e.g, patient is not eligible for further platinum containing treatment). Patients may have had up to 4 lines of cytotoxic therapy for advanced or metastatic cancer. Neoadjuvant, adjuvant, and the combination of both will be considered as one line of therapy.

  • Archival tumor tissue available or a fresh biopsy must be obtained prior to study treatment initiation

  • Measurable lesions by RECIST v1.1

  • Eastern Cooperative Oncology Group (ECOG) 0 or 1

  • Adequate organ function

  • Able to take oral medications

  • Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours of taking study medication and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment

  • Male patient agrees to use an adequate method of contraception

Main Exclusion Criteria:
  • Patients with primary platinum refractory ovarian cancer (ie, progressive disease on or within 6 months of first-line platinum therapy)

  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis Note: Patients previously treated for brain metastases may be able to participate provided they are stable

  • Patient has a known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer

  • Poor medical risk

  • Condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.

  • Pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study

  • Immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment

  • Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)

  • Known active hepatitis B or hepatitis C

  • Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

  • Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

  • Prior treatment with a known poly(ADP-ribose) polymerase (PARP) inhibitor

  • Heart-rate corrected QT interval (QTc) prolongation > 470 msec at screening

  • Known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1GSK Investigational SiteBirminghamAlabamaUnited States35249
2GSK Investigational SitePhoenixArizonaUnited States85054
3GSK Investigational SiteScottsdaleArizonaUnited States85258
4GSK Investigational SiteLos AngelesCaliforniaUnited States90048
5GSK Investigational SiteSan FranciscoCaliforniaUnited States94115
6GSK Investigational SiteStanfordCaliforniaUnited States94305
7GSK Investigational SiteWashingtonDistrict of ColumbiaUnited States20007
8GSK Investigational SiteDeerfield BeachFloridaUnited States33442
9GSK Investigational SiteJacksonvilleFloridaUnited States32224
10GSK Investigational SiteMiamiFloridaUnited States33136
11GSK Investigational SiteOrlandoFloridaUnited States32804
12GSK Investigational SiteChicagoIllinoisUnited States60637
13GSK Investigational SiteCovingtonLouisianaUnited States70433
14GSK Investigational SiteBostonMassachusettsUnited States02111
15GSK Investigational SiteBostonMassachusettsUnited States02114
16GSK Investigational SiteBostonMassachusettsUnited States02115
17GSK Investigational SiteBurlingtonMassachusettsUnited States01805
18GSK Investigational SiteDetroitMichiganUnited States48201
19GSK Investigational SiteRochesterMinnesotaUnited States55905
20GSK Investigational SiteMorristownNew JerseyUnited States07962
21GSK Investigational SiteNew YorkNew YorkUnited States10065
22GSK Investigational SiteChapel HillNorth CarolinaUnited States27514
23GSK Investigational SiteCharlotteNorth CarolinaUnited States28204
24GSK Investigational SiteClevelandOhioUnited States44106
25GSK Investigational SiteOklahoma CityOklahomaUnited States73104
26GSK Investigational SiteGermantownTennesseeUnited States38138
27GSK Investigational SiteNashvilleTennesseeUnited States37203
28GSK Investigational SiteSan AntonioTexasUnited States78229
29GSK Investigational SiteCharlottesvilleVirginiaUnited States22903
30GSK Investigational SiteSeattleWashingtonUnited States98109

Sponsors and Collaborators

  • Tesaro, Inc.
  • Merck Sharp & Dohme Corp.

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Tesaro, Inc.
ClinicalTrials.gov Identifier:
NCT02657889
Other Study ID Numbers:
  • 213363
  • 3000-PN162-01-001
First Posted:
Jan 18, 2016
Last Update Posted:
Oct 27, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Tesaro, Inc.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitlePhase 1: Niraparib 200mg + PembrolizumabPhase 1: Niraparib 300mg + PembrolizumabPhase 2 OC: Niraparib 200mg + PembrolizumabPhase 2 TNBC: Niraparib 200mg + Pembrolizumab
Arm/Group DescriptionNiraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Ovarian Cancer: Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Triple Negative Breast Cancer: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
Period Title: Overall Study
STARTED775355
COMPLETED0000
NOT COMPLETED775355

Baseline Characteristics

Arm/Group TitlePhase 1: Niraparib 200mg + PembrolizumabPhase 1: Niraparib 300mg + PembrolizumabPhase 2 OC: Niraparib 200mg + PembrolizumabPhase 2 TNBC: Niraparib 200mg + PembrolizumabTotal
Arm/Group DescriptionNiraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Ovarian Cancer: Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Triple Negative Breast Cancer: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Total of all reporting groups
Overall Participants775355122
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
4
57.1%
4
57.1%
37
69.8%
47
85.5%
92
75.4%
>=65 years
3
42.9%
3
42.9%
16
30.2%
8
14.5%
30
24.6%
Sex: Female, Male (Count of Participants)
Female
7
100%
7
100%
53
100%
55
100%
122
100%
Male
0
0%
0
0%
0
0%
0
0%
0
0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
1
14.3%
0
0%
3
5.7%
3
5.5%
7
5.7%
Not Hispanic or Latino
6
85.7%
6
85.7%
50
94.3%
51
92.7%
113
92.6%
Unknown or Not Reported
0
0%
1
14.3%
0
0%
1
1.8%
2
1.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
3
5.7%
2
3.6%
5
4.1%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
0
0%
Black or African American
0
0%
0
0%
1
1.9%
8
14.5%
9
7.4%
White
7
100%
7
100%
46
86.8%
43
78.2%
103
84.4%
More than one race
NA
NaN
NA
NaN
NA
NaN
NA
NaN
NA
NaN
Unknown or Not Reported
0
0%
0
0%
3
5.7%
2
3.6%
5
4.1%
Region of Enrollment (Count of Participants)
United States
7
100%
7
100%
53
100%
55
100%
122
100%

Outcome Measures

1. Primary Outcome
TitlePhase 1: Number of Subjects Reporting Dose-Limiting Toxicities (DLTs)
DescriptionDLTs are defined as: Any treatment-related Grade ≥ 3 non-hematologic clinical (non-laboratory) AE Any treatment-related Grade 3 or Grade 4 non-hematologic lab abnormality if: - Medical intervention is required to treat the patient, or - The abnormality leads to hospitalization, or - The abnormality persists for ≥ 7 days. Any treatment-related hematologic toxicity specifically defined as: - Thrombocytopenia Grade 4 for ≥ 7 days, or Grade 3 or 4 associated with bleeding or requiring platelet transfusion; - Neutropenia Grade 4 for ≥ 7 days, or Grade 3 or 4 associated with infection or febrile neutropenia; - Anemia Grade 4, or Grade 3 or 4 requiring blood transfusion. Any treatment-related AE leading to niraparib dose interruption per the following criteria: - A dose interruption for a non-DLT lab abnormality lasting ≥ 14 days. - A dose in interruption per dose modification rules for nonhematologic AE leading to < 80% of an intended dose being administered.
Time FrameDuring Cycle 1, ie, during the first 21 days of treatment

Outcome Measure Data

Analysis Population Description
The assessment of DLTs in Phase 1 included only those patients completing the first cycle of therapy, unless the patient discontinued study drug due to a DLT.
Arm/Group TitlePhase 1: Niraparib 200mg + PembrolizumabPhase 1: Niraparib 300mg + Pembrolizumab
Arm/Group DescriptionNiraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
Measure Participants66
Count of Participants [Participants]
1
14.3%
1
14.3%
2. Primary Outcome
TitlePhase 2: Objective Response Rate (ORR)
DescriptionORR is defined as the percentage of patients who achieved a best overall response of Complete Response (CR) or Partial Response (PR), per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by the Investigator: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time FrameUp to 40 weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on all patients who received at least one dose of study medication.
Arm/Group TitlePhase 2 OC: Niraparib 200mg + PembrolizumabPhase 2 TNBC: Niraparib 200mg + Pembrolizumab
Arm/Group DescriptionOvarian Cancer: Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Triple Negative Breast Cancer: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
Measure Participants5355
Number (90% Confidence Interval) [percentage of participants]
15.1
215.7%
18.2
260%
3. Secondary Outcome
TitleTo Evaluate the Safety and Tolerability of Combination Treatment With Niraparib and Pembrolizumab Using Common Terminology Criteria for Adverse Events (CTCAE, v4.03)
DescriptionPercentage of patients with at least 1 Treatment-Emergent Adverse Event. Refer to the adverse event tables for specific details.
Time FrameAEs were collected up to 90 days following the last dose of study treatment, where the median duration of treatment was 3 months.

Outcome Measure Data

Analysis Population Description
The analysis was performed on all patients who received at least one dose of study medication.
Arm/Group TitlePhase 1: Niraparib 200mg + PembrolizumabPhase 1: Niraparib 300mg + PembrolizumabPhase 2 OC: Niraparib 200mg + PembrolizumabPhase 2 TNBC: Niraparib 200mg + Pembrolizumab
Arm/Group DescriptionNiraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Ovarian Cancer: Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Triple Negative Breast Cancer: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
Measure Participants775355
Count of Participants [Participants]
7
100%
7
100%
53
100%
55
100%
4. Secondary Outcome
TitlePhase 2: Overall Response Rate (ORR) as Measured by Immune-related RECIST (irRECIST)
DescriptionORR by irRECIST is defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR) using immune-related RECIST criteria.
Time FrameRadiographic evaluations were conducted every 9 weeks while on study treatment (every 12 weeks after 1 year of scans) independent of cycle delays and/or dose interruptions, and/or at any time when progression of disease is suspected.

Outcome Measure Data

Analysis Population Description
Data were not collected.
Arm/Group TitlePhase 2 OC: Niraparib 200mg + PembrolizumabPhase 2 TNBC: Niraparib 200mg + Pembrolizumab
Arm/Group DescriptionOvarian Cancer: Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Triple Negative Breast Cancer: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
Measure Participants00
5. Secondary Outcome
TitlePhase 2: Duration of Response (DOR)
DescriptionFrom first documentation of response (CR or PR) using RECIST (v1.1) as assessed by the investigator until time of first documented progression or death by any cause. No maximum timeframe was specified in the protocol.
Time FrameFrom first documentation of response (CR or PR) using RECIST (v1.1) as assessed by the Investigator until time of first documented progression.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
6. Secondary Outcome
TitlePhase 2: Disease Control Rate (DCR)
DescriptionDCR is defined as the percentage of patients who achieved a CR or PR or stable disease (SD) using RECIST (v1.1) as assessed by the Investigator.
Time FrameUp to 40 weeks

Outcome Measure Data

Analysis Population Description
The analysis was performed on all patients who received at least one dose of study medication.
Arm/Group TitlePhase 2 OC: Niraparib 200mg + PembrolizumabPhase 2 TNBC: Niraparib 200mg + Pembrolizumab
Arm/Group DescriptionOvarian Cancer: Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Triple Negative Breast Cancer: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
Measure Participants5355
Number (90% Confidence Interval) [percentage of participants]
58.5
835.7%
41.8
597.1%
7. Secondary Outcome
TitlePhase 2: Progression Free Survival (PFS)
DescriptionFrom date of first dose to the earlier date of assessment of progression or death by any cause in the absence of progression. No maximum timeframe was specified in the protocol.
Time FrameFrom date of first dose to the earlier date of assessment of progression of death by any cause in the absence of progression.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
8. Secondary Outcome
TitlePhase 2: Overall Survival (OS)
DescriptionPatients were followed off treatment every 90 days for survival status. Overall survival is defined as the time from first dose to the date of death by any cause. No maximum timeframe was specified in the protocol.
Time FrameFrom date of first dose to the date of death by any cause.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
9. Secondary Outcome
TitlePhase 1 and Phase 2: To Evaluate the Pharmacokinetics (PK) of Niraparib and Associated Major Metabolite M1 During Combination Treatment.
DescriptionArea Under the Curve (AUC), Minimum Concentration (Cmin), Maximum Concentration (Cmax), Clearance After Oral Administration (CL/F), Volume of Distribution After Oral Administration (Vz/F), AUC at Steady State (AUCss), Cmin at Steady State (Cmin,ss), Cmax at Steady State (Cmax,ss).
Time FrameApproximately 9 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description

Adverse Events

Time FrameAEs were collected up to 90 days following the last dose of study treatment, where the median duration of treatment was 3 months.
Adverse Event Reporting Description
Arm/Group TitlePhase 1: Niraparib 200mg + PembrolizumabPhase 1: Niraparib 300mg + PembrolizumabPhase 2 OC: Niraparib 200mg + PembrolizumabPhase 2 TNBC: Niraparib 200mg + Pembrolizumab
Arm/Group DescriptionNiraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Ovarian Cancer: Niraparib 200mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.Triple Negative Breast Cancer: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
All Cause Mortality
Phase 1: Niraparib 200mg + PembrolizumabPhase 1: Niraparib 300mg + PembrolizumabPhase 2 OC: Niraparib 200mg + PembrolizumabPhase 2 TNBC: Niraparib 200mg + Pembrolizumab
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total5/7 (71.4%) 2/7 (28.6%) 20/53 (37.7%) 34/55 (61.8%)
Serious Adverse Events
Phase 1: Niraparib 200mg + PembrolizumabPhase 1: Niraparib 300mg + PembrolizumabPhase 2 OC: Niraparib 200mg + PembrolizumabPhase 2 TNBC: Niraparib 200mg + Pembrolizumab
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total6/7 (85.7%) 4/7 (57.1%) 20/53 (37.7%) 22/55 (40%)
Blood and lymphatic system disorders
Anemia1/7 (14.3%) 0/7 (0%) 1/53 (1.9%) 1/55 (1.8%)
Febrile neutropenia0/7 (0%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Leukopenia0/7 (0%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Neutropenia1/7 (14.3%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Pancytopenia0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Thrombocytopenia1/7 (14.3%) 3/7 (42.9%) 2/53 (3.8%) 3/55 (5.5%)
Cardiac disorders
Cardiac failure congestive0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Cardiac tamponade0/7 (0%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Pericardial effusion0/7 (0%) 0/7 (0%) 2/53 (3.8%) 1/55 (1.8%)
Tachycardia0/7 (0%) 0/7 (0%) 1/53 (1.9%) 1/55 (1.8%)
Endocrine disorders
Adrenal insufficiency0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Gastrointestinal disorders
Abdominal distension1/7 (14.3%) 0/7 (0%) 0/53 (0%) 0/55 (0%)
Abdominal pain2/7 (28.6%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Ascites1/7 (14.3%) 0/7 (0%) 0/53 (0%) 0/55 (0%)
Colitis1/7 (14.3%) 0/7 (0%) 0/53 (0%) 0/55 (0%)
Constipation0/7 (0%) 0/7 (0%) 4/53 (7.5%) 0/55 (0%)
Intestinal perforation0/7 (0%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Nausea2/7 (28.6%) 1/7 (14.3%) 2/53 (3.8%) 0/55 (0%)
Obstruction gastric1/7 (14.3%) 0/7 (0%) 0/53 (0%) 0/55 (0%)
Pancreatitis acute0/7 (0%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Small intestinal obstruction1/7 (14.3%) 0/7 (0%) 5/53 (9.4%) 0/55 (0%)
Vomiting1/7 (14.3%) 0/7 (0%) 4/53 (7.5%) 0/55 (0%)
General disorders
Asthenia0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Chills0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Fatigue0/7 (0%) 0/7 (0%) 1/53 (1.9%) 2/55 (3.6%)
Malaise0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Non-cardiac chest pain0/7 (0%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Oedema peripheral0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Pyrexia0/7 (0%) 0/7 (0%) 0/53 (0%) 3/55 (5.5%)
Hepatobiliary disorders
Bile duct stenosis0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Cholecystitis1/7 (14.3%) 0/7 (0%) 0/53 (0%) 0/55 (0%)
Infections and infestations
Device related infection0/7 (0%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Gastroenteritis viral0/7 (0%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Lung infection0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Neutropenic sepsis0/7 (0%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Pneumonia0/7 (0%) 0/7 (0%) 1/53 (1.9%) 2/55 (3.6%)
Stoma site infection0/7 (0%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Injury, poisoning and procedural complications
Femur fracture0/7 (0%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Procedural pneumothorax1/7 (14.3%) 0/7 (0%) 0/53 (0%) 0/55 (0%)
Investigations
Amylase increased0/7 (0%) 0/7 (0%) 1/53 (1.9%) 1/55 (1.8%)
Aspartate aminotransferase increased0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Blood alkaline phosphatase increased0/7 (0%) 0/7 (0%) 0/53 (0%) 2/55 (3.6%)
Blood bilirubin increased0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Blood creatinine increased0/7 (0%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Liver function test increased0/7 (0%) 0/7 (0%) 1/53 (1.9%) 1/55 (1.8%)
Platelet count decreased0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Metabolism and nutrition disorders
Dehydration0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Failure to thrive0/7 (0%) 0/7 (0%) 2/53 (3.8%) 0/55 (0%)
Hyperglycaemia1/7 (14.3%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Hyperkalaemia0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Musculoskeletal and connective tissue disorders
Back pain1/7 (14.3%) 0/7 (0%) 0/53 (0%) 0/55 (0%)
Pain in extremity0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Pathological fracture0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion1/7 (14.3%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Metastases to central nervous system0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Nervous system disorders
Cerebral haemorrhage0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Dizziness0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Encephalopathy0/7 (0%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Headache0/7 (0%) 0/7 (0%) 0/53 (0%) 3/55 (5.5%)
Psychiatric disorders
Mental status changes1/7 (14.3%) 0/7 (0%) 1/53 (1.9%) 1/55 (1.8%)
Renal and urinary disorders
Acute kidney injury0/7 (0%) 0/7 (0%) 0/53 (0%) 3/55 (5.5%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Dyspnoea0/7 (0%) 1/7 (14.3%) 2/53 (3.8%) 1/55 (1.8%)
Dyspnoea exertional0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Hypoxia0/7 (0%) 0/7 (0%) 0/53 (0%) 3/55 (5.5%)
Pleural effusion0/7 (0%) 1/7 (14.3%) 1/53 (1.9%) 4/55 (7.3%)
Pneumonia aspiration1/7 (14.3%) 0/7 (0%) 0/53 (0%) 0/55 (0%)
Pneumonitis1/7 (14.3%) 0/7 (0%) 0/53 (0%) 0/55 (0%)
Pneumothorax0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Pulmonary embolism1/7 (14.3%) 0/7 (0%) 1/53 (1.9%) 1/55 (1.8%)
Respiratory failure0/7 (0%) 0/7 (0%) 1/53 (1.9%) 1/55 (1.8%)
Skin and subcutaneous tissue disorders
Decubitus ulcer0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Rash pruritic0/7 (0%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Vascular disorders
Embolism1/7 (14.3%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Hypotension0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Orthostatic hypotension0/7 (0%) 0/7 (0%) 0/53 (0%) 1/55 (1.8%)
Other (Not Including Serious) Adverse Events
Phase 1: Niraparib 200mg + PembrolizumabPhase 1: Niraparib 300mg + PembrolizumabPhase 2 OC: Niraparib 200mg + PembrolizumabPhase 2 TNBC: Niraparib 200mg + Pembrolizumab
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total7/7 (100%) 7/7 (100%) 52/53 (98.1%) 54/55 (98.2%)
Blood and lymphatic system disorders
Anaemia5/7 (71.4%) 5/7 (71.4%) 19/53 (35.8%) 23/55 (41.8%)
Leukocytosis1/7 (14.3%) 0/7 (0%) 0/53 (0%) 0/55 (0%)
Lymphopenia1/7 (14.3%) 1/7 (14.3%) 0/53 (0%) 2/55 (3.6%)
Neutropenia1/7 (14.3%) 1/7 (14.3%) 4/53 (7.5%) 3/55 (5.5%)
Thrombocytopenia1/7 (14.3%) 4/7 (57.1%) 14/53 (26.4%) 13/55 (23.6%)
Cardiac disorders
Diastolic dysfunction0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Tachycardia2/7 (28.6%) 1/7 (14.3%) 2/53 (3.8%) 2/55 (3.6%)
Endocrine disorders
Hyperthyroidism0/7 (0%) 0/7 (0%) 1/53 (1.9%) 3/55 (5.5%)
Hypothyroidism2/7 (28.6%) 0/7 (0%) 7/53 (13.2%) 6/55 (10.9%)
Eye disorders
Cataract0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Dry eye0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Lacrimation increased0/7 (0%) 2/7 (28.6%) 0/53 (0%) 0/55 (0%)
Ocular hyperaemia0/7 (0%) 1/7 (14.3%) 1/53 (1.9%) 1/55 (1.8%)
Vision blurred0/7 (0%) 2/7 (28.6%) 1/53 (1.9%) 0/55 (0%)
Gastrointestinal disorders
Abdominal discomfort0/7 (0%) 0/7 (0%) 3/53 (5.7%) 0/55 (0%)
Abdominal distension3/7 (42.9%) 0/7 (0%) 5/53 (9.4%) 3/55 (5.5%)
Abdominal pain3/7 (42.9%) 0/7 (0%) 15/53 (28.3%) 7/55 (12.7%)
Abdominal pain upper1/7 (14.3%) 1/7 (14.3%) 3/53 (5.7%) 2/55 (3.6%)
Ascites1/7 (14.3%) 0/7 (0%) 5/53 (9.4%) 0/55 (0%)
Colitis1/7 (14.3%) 0/7 (0%) 0/53 (0%) 0/55 (0%)
Constipation5/7 (71.4%) 2/7 (28.6%) 28/53 (52.8%) 24/55 (43.6%)
Diarrhoea2/7 (28.6%) 2/7 (28.6%) 15/53 (28.3%) 12/55 (21.8%)
Dry mouth1/7 (14.3%) 0/7 (0%) 4/53 (7.5%) 4/55 (7.3%)
Dyspepsia1/7 (14.3%) 2/7 (28.6%) 5/53 (9.4%) 2/55 (3.6%)
Gastrooesophageal reflux disease1/7 (14.3%) 0/7 (0%) 4/53 (7.5%) 2/55 (3.6%)
Nausea4/7 (57.1%) 4/7 (57.1%) 32/53 (60.4%) 34/55 (61.8%)
Noninfective gingivitis0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Stomatitis1/7 (14.3%) 0/7 (0%) 3/53 (5.7%) 4/55 (7.3%)
Toothache0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Vomiting4/7 (57.1%) 2/7 (28.6%) 20/53 (37.7%) 12/55 (21.8%)
General disorders
Asthenia0/7 (0%) 0/7 (0%) 3/53 (5.7%) 1/55 (1.8%)
Chills0/7 (0%) 0/7 (0%) 3/53 (5.7%) 2/55 (3.6%)
Fatigue4/7 (57.1%) 3/7 (42.9%) 32/53 (60.4%) 30/55 (54.5%)
Local swelling0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Oedema peripheral3/7 (42.9%) 1/7 (14.3%) 2/53 (3.8%) 4/55 (7.3%)
Pain0/7 (0%) 0/7 (0%) 2/53 (3.8%) 3/55 (5.5%)
Peripheral swelling0/7 (0%) 1/7 (14.3%) 4/53 (7.5%) 1/55 (1.8%)
Pyrexia0/7 (0%) 0/7 (0%) 7/53 (13.2%) 4/55 (7.3%)
Infections and infestations
Conjunctivitis1/7 (14.3%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Eye infection0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Laryngitis0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Pneumonia0/7 (0%) 0/7 (0%) 0/53 (0%) 4/55 (7.3%)
Sinusitis0/7 (0%) 0/7 (0%) 2/53 (3.8%) 3/55 (5.5%)
Upper respiratory tract infection0/7 (0%) 1/7 (14.3%) 1/53 (1.9%) 5/55 (9.1%)
Urinary tract infection0/7 (0%) 0/7 (0%) 7/53 (13.2%) 9/55 (16.4%)
Injury, poisoning and procedural complications
Contusion0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Fall0/7 (0%) 1/7 (14.3%) 0/53 (0%) 1/55 (1.8%)
Overdose0/7 (0%) 0/7 (0%) 3/53 (5.7%) 3/55 (5.5%)
Investigations
Alanine aminotransferase increased0/7 (0%) 0/7 (0%) 8/53 (15.1%) 10/55 (18.2%)
Amylase increased0/7 (0%) 0/7 (0%) 3/53 (5.7%) 2/55 (3.6%)
Anticoagulation drug level increased0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Aspartate aminotransferase increased1/7 (14.3%) 1/7 (14.3%) 8/53 (15.1%) 14/55 (25.5%)
Blood alkaline phosphatase decreased1/7 (14.3%) 0/7 (0%) 0/53 (0%) 0/55 (0%)
Blood alkaline phosphatase increased2/7 (28.6%) 0/7 (0%) 6/53 (11.3%) 9/55 (16.4%)
Blood creatinine increased0/7 (0%) 0/7 (0%) 4/53 (7.5%) 4/55 (7.3%)
Creatinine renal clearance increased0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Electrocardiogram QT prolonged0/7 (0%) 0/7 (0%) 1/53 (1.9%) 3/55 (5.5%)
Lymphocyte count decreased1/7 (14.3%) 1/7 (14.3%) 2/53 (3.8%) 10/55 (18.2%)
Neutrophil count decreased0/7 (0%) 0/7 (0%) 7/53 (13.2%) 6/55 (10.9%)
Platelet count decreased0/7 (0%) 2/7 (28.6%) 7/53 (13.2%) 9/55 (16.4%)
Troponin increased0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Weight decreased1/7 (14.3%) 1/7 (14.3%) 8/53 (15.1%) 3/55 (5.5%)
White blood cell count decreased1/7 (14.3%) 1/7 (14.3%) 4/53 (7.5%) 6/55 (10.9%)
Metabolism and nutrition disorders
Decreased appetite2/7 (28.6%) 3/7 (42.9%) 17/53 (32.1%) 14/55 (25.5%)
Dehydration1/7 (14.3%) 3/7 (42.9%) 6/53 (11.3%) 6/55 (10.9%)
Hyperglycaemia0/7 (0%) 1/7 (14.3%) 5/53 (9.4%) 5/55 (9.1%)
Hypoalbuminaemia3/7 (42.9%) 0/7 (0%) 1/53 (1.9%) 2/55 (3.6%)
Hypocalcaemia1/7 (14.3%) 0/7 (0%) 1/53 (1.9%) 4/55 (7.3%)
Hypokalaemia3/7 (42.9%) 1/7 (14.3%) 6/53 (11.3%) 6/55 (10.9%)
Hypomagnesaemia3/7 (42.9%) 1/7 (14.3%) 7/53 (13.2%) 5/55 (9.1%)
Hyponatraemia4/7 (57.1%) 3/7 (42.9%) 6/53 (11.3%) 6/55 (10.9%)
Musculoskeletal and connective tissue disorders
Arthralgia1/7 (14.3%) 0/7 (0%) 7/53 (13.2%) 9/55 (16.4%)
Back pain1/7 (14.3%) 1/7 (14.3%) 8/53 (15.1%) 8/55 (14.5%)
Flank pain0/7 (0%) 0/7 (0%) 3/53 (5.7%) 3/55 (5.5%)
Muscular weakness0/7 (0%) 2/7 (28.6%) 2/53 (3.8%) 3/55 (5.5%)
Musculoskeletal chest pain0/7 (0%) 1/7 (14.3%) 2/53 (3.8%) 3/55 (5.5%)
Musculoskeletal pain0/7 (0%) 0/7 (0%) 2/53 (3.8%) 5/55 (9.1%)
Myalgia0/7 (0%) 0/7 (0%) 7/53 (13.2%) 3/55 (5.5%)
Neck pain0/7 (0%) 1/7 (14.3%) 0/53 (0%) 3/55 (5.5%)
Pain in extremity1/7 (14.3%) 1/7 (14.3%) 1/53 (1.9%) 6/55 (10.9%)
Nervous system disorders
Ataxia1/7 (14.3%) 0/7 (0%) 0/53 (0%) 0/55 (0%)
Dizziness2/7 (28.6%) 1/7 (14.3%) 6/53 (11.3%) 6/55 (10.9%)
Dysgeusia1/7 (14.3%) 3/7 (42.9%) 4/53 (7.5%) 6/55 (10.9%)
Headache2/7 (28.6%) 2/7 (28.6%) 14/53 (26.4%) 14/55 (25.5%)
Neuropathy peripheral0/7 (0%) 0/7 (0%) 3/53 (5.7%) 4/55 (7.3%)
Peripheral sensory neuropathy0/7 (0%) 1/7 (14.3%) 0/53 (0%) 1/55 (1.8%)
Psychiatric disorders
Anxiety0/7 (0%) 3/7 (42.9%) 3/53 (5.7%) 6/55 (10.9%)
Confusional state1/7 (14.3%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Depression1/7 (14.3%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Insomnia2/7 (28.6%) 3/7 (42.9%) 11/53 (20.8%) 13/55 (23.6%)
Renal and urinary disorders
Acute kidney injury0/7 (0%) 0/7 (0%) 0/53 (0%) 3/55 (5.5%)
Chronic kidney disease0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Costovertebral angle tenderness0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Haematuria1/7 (14.3%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Proteinuria1/7 (14.3%) 0/7 (0%) 2/53 (3.8%) 1/55 (1.8%)
Reproductive system and breast disorders
Breast tenderness0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Pelvic pain1/7 (14.3%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Vaginal haemorrhage0/7 (0%) 1/7 (14.3%) 0/53 (0%) 1/55 (1.8%)
Respiratory, thoracic and mediastinal disorders
Cough1/7 (14.3%) 2/7 (28.6%) 9/53 (17%) 18/55 (32.7%)
Dyspnoea3/7 (42.9%) 4/7 (57.1%) 11/53 (20.8%) 20/55 (36.4%)
Dyspnoea exertional1/7 (14.3%) 1/7 (14.3%) 2/53 (3.8%) 2/55 (3.6%)
Epistaxis0/7 (0%) 2/7 (28.6%) 0/53 (0%) 1/55 (1.8%)
Hypoxia1/7 (14.3%) 0/7 (0%) 0/53 (0%) 2/55 (3.6%)
Nasal congestion0/7 (0%) 1/7 (14.3%) 2/53 (3.8%) 5/55 (9.1%)
Oropharyngeal pain2/7 (28.6%) 0/7 (0%) 2/53 (3.8%) 1/55 (1.8%)
Pleural effusion1/7 (14.3%) 0/7 (0%) 3/53 (5.7%) 3/55 (5.5%)
Pleuritic pain1/7 (14.3%) 0/7 (0%) 0/53 (0%) 0/55 (0%)
Productive cough0/7 (0%) 0/7 (0%) 2/53 (3.8%) 3/55 (5.5%)
Pulmonary hypertension0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Upper-airway cough syndrome1/7 (14.3%) 0/7 (0%) 1/53 (1.9%) 0/55 (0%)
Skin and subcutaneous tissue disorders
Dermatitis contact0/7 (0%) 1/7 (14.3%) 0/53 (0%) 1/55 (1.8%)
Dry skin1/7 (14.3%) 2/7 (28.6%) 1/53 (1.9%) 2/55 (3.6%)
Erythema0/7 (0%) 1/7 (14.3%) 2/53 (3.8%) 1/55 (1.8%)
Night sweats1/7 (14.3%) 0/7 (0%) 1/53 (1.9%) 2/55 (3.6%)
Onychoclasis0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Onychomadesis0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Photosensitivity reaction1/7 (14.3%) 1/7 (14.3%) 1/53 (1.9%) 2/55 (3.6%)
Pruritus0/7 (0%) 1/7 (14.3%) 9/53 (17%) 4/55 (7.3%)
Rash1/7 (14.3%) 1/7 (14.3%) 6/53 (11.3%) 7/55 (12.7%)
Rash maculo-papular0/7 (0%) 0/7 (0%) 2/53 (3.8%) 3/55 (5.5%)
Skin lesion0/7 (0%) 1/7 (14.3%) 0/53 (0%) 0/55 (0%)
Vascular disorders
Hot flush0/7 (0%) 1/7 (14.3%) 0/53 (0%) 7/55 (12.7%)
Hypertension0/7 (0%) 0/7 (0%) 5/53 (9.4%) 4/55 (7.3%)
Lymphoedema0/7 (0%) 0/7 (0%) 0/53 (0%) 3/55 (5.5%)

Limitations/Caveats

This study is ongoing. Study visit and data collection activities are still being performed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Neither Institution nor Investigator will submit for publication or public disclosure any publication or disclosure based on the results of the Study until after the first to occur of (a) publication of the Multi-Center Clinical Trial results; (b) notification by Sponsor that the Multi-Center Clinical Trial submission is no longer planned; or (c) the eighteen (18) month anniversary of the completion or early termination of the Multi-Center Clinical Trial.

Results Point of Contact

Name/TitleGSK Response Center
OrganizationGlaxoSmithKline
Phone866-435-7343
EmailGSKClinicalSupportHD@gsk.com
Responsible Party:
Tesaro, Inc.
ClinicalTrials.gov Identifier:
NCT02657889
Other Study ID Numbers:
  • 213363
  • 3000-PN162-01-001
First Posted:
Jan 18, 2016
Last Update Posted:
Oct 27, 2021
Last Verified:
Oct 1, 2021