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A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03414047
Collaborator
(none)
172
Enrollment
46
Locations
4
Arms
29.8
Actual Duration (Months)
3.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
172 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
Actual Study Start Date :
Apr 10, 2018
Actual Primary Completion Date :
Jun 3, 2019
Actual Study Completion Date :
Oct 3, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prexasertib Cohort 1

Participants received 105 milligram per square meter (mg/m²) prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy.

Drug: Prexasertib
Administered IV
Other Names:
  • LY2606368

    		•
    Experimental: Prexasertib Cohort 2

    Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy.

    Drug: Prexasertib
    Administered IV
    Other Names:
  • LY2606368

    		•
    Experimental: Prexasertib Cohort 3

    Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.

    Drug: Prexasertib
    Administered IV
    Other Names:
  • LY2606368

    		•
    Experimental: Prexasertib Cohort 4

    Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.

    Drug: Prexasertib
    Administered IV
    Other Names:
  • LY2606368

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR) [Baseline through Disease Progression (Up to 6 months)]

      Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100.

    Secondary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib [Cycle 1, Cycle 2, Cycle 4, Cycle 6 (Day 1 (End of prexasertib infusion (+15 min), 1-2 hours following end of prexasertib infusion), Cycle 2, day 1(Prior to start of prexasertib infusion)]

      Pharmacokinetics(PK): Maximum Plasma Concentration of Prexasertib. The same dose was administered to Cohort 1, 2, 3 and 4 and were combined for analysis.

    2. Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months [Baseline through Disease Progression (up to 6 months)]

      DCR is defined as the number of participants who achieve a best overall response of CR, PR or SD for ≥4 months as determined by per RECIST version 1.1. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.

    3. Duration of Response [Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (up to 20 months)]

      Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.

    4. Percentage of Participants With at Least a 50% Reduction in CA-125 Levels From Baseline [Baseline, 4 Weeks]

      CA-125 response is defined as ≥50% reduction in CA-125 levels from a pretreatment sample. The response must be confirmed and maintained for ≥28 days according to GCIG criteria. Participants must have a pretreatment sample that is ≥2 times the upper limit of the reference range and obtained within 2 weeks before starting the treatment.

    5. Progression-Free Survival [Baseline to Disease Progression or Death from any Cause (Up to 22 months)]

      Progression-Free Survival (PFS) is defined as the time from the date of enrollment until the first occurrence of documented disease progression per RECIST 1.1, or death from any cause in the absence of progressive disease (PD). Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.

    6. Overall Survival [Baseline to Date of Death from Any Cause (Up to 26 months)]

      Overall survival (OS) is defined as the time from the date of enrollment until death from any cause. If the participant is alive, lost to follow-up or withdrawn from study at the time of data analysis, OS data will be censored on the last date the participant is known to be alive.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.

    • Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.

    • Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.

    • Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.

    • Cohort 3: Are BRCA positive and have previously received a PARP.

    • Cohort 4: Have primary platinum refractory disease.

    • Have adequate organ function.

    • Must be able and willing to undergo mandatory tumor biopsy.

    Exclusion Criteria:

    • Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.

    • Have known central nervous system malignancy or metastasis.

    • Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.

    • Have at least one of the following:

    • history of abdominal fistula or gastrointestinal perforation

    • intra-abdominal abscess within last 3 months prior to the first dose of study drug

    • a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug

    • Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).

    • Have a serious cardiac condition.

    • Have a history of prior radiotherapy to the whole pelvis.

    • Have chronic daily treatment with corticosteroids, excluding inhaled or topical steroids.

    • Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Oncology Associates, P.C. Tucson Arizona United States 85711
    2 Kaiser Permanente Medical Center Vallejo California United States 94589
    3 University of Southern Florida School of Medicine Gainesville Florida United States 32610-0296
    4 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    5 Research Medical Center Kansas City Missouri United States 63142
    6 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756-0001
    7 Cancer Care Associates Tulsa Oklahoma United States 74146
    8 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    9 Rhode Island Hospital Providence Rhode Island United States 02903
    10 Sioux Valley Clinic Sioux Falls South Dakota United States 57104
    11 University of Tennessee Medical Center Knoxville Tennessee United States 37920
    12 Sarah Cannon Research Institute SCRI Nashville Tennessee United States 37203
    13 Tennessee Oncology PLLC Nashville Tennessee United States 37203
    14 Seattle Cancer Care Alliance Seattle Washington United States 98109
    15 Concord Repatriation General Hospital Concord New South Wales Australia 2139
    16 Prince of Wales Hospital Randwick New South Wales Australia 2031
    17 Westmead Hospital Wentworthville New South Wales Australia 2145
    18 Royal Brisbane and Womens Hospital Herston Queensland Australia 4029
    19 Mater Adult Hospital Brisbane South Brisbane Queensland Australia 4101
    20 Flinders Medical Centre Bedford Park South Australia Australia 5042
    21 Burnside War Memorial Hospital Toorak Gardens South Australia Australia 5065
    22 Peter MacCallum Cancer Centre Melbourne Victoria Australia 3000
    23 Institut Jules Bordet Brussel Belgium 1000
    24 Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium 3000
    25 GZA St Augustinus Wilrijk Belgium 2610
    26 Rambam Medical Center Haifa Israel 3109601
    27 Shaare Zedek Medical Center Jerusalem Israel 9103102
    28 Sheba Medical Center Ramat Gan Israel 5265601
    29 Policlinico Univ. Agostino Gemelli Roma Lazio Italy 00168
    30 Istituto Europeo di Oncologia Milano Milan Italy 20141
    31 Istituto Tumori Fondazione G. Pascale IRCCS Napoli Naples Italy 80131
    32 Samsung Medical Center Seoul Korea Korea, Republic of 06351
    33 Seoul National University Hospital Seoul Korea, Republic of 03080
    34 Asan Medical Center Seoul Korea, Republic of 05505
    35 Severance Hospital Yonsei University Health System Seoul Korea, Republic of 120-792
    36 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    37 Hospital Reina Sofia Cordoba Spain 14004
    38 Hospital Universitario Ramon y Cajal Madrid Spain 28034
    39 Hospital Universitario 12 de Octubre Madrid Spain 28041
    40 Hospital Universitario La Paz Madrid Spain 28046
    41 University College Hospital - London London Greater London United Kingdom NW1 2BU
    42 Christie NHS Foundation Trust Manchester Greater Manchester United Kingdom M20 4BX
    43 Mount Vernon Hospital Northwood Middlesex United Kingdom HA6 2RN
    44 Royal Surrey County Hospital Guildford Surrey United Kingdom GU2 7XX
    45 Royal Marsden Hospital Sutton Surrey United Kingdom SM2 5PT
    46 Northampton General Hospital Northampton United Kingdom NN1 5BD

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03414047
    Other Study ID Numbers:
    • 16712
    • I4D-MC-JTJN
    • 2017-004009-42
    First Posted:
    Jan 29, 2018
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    DNA damage repair
    replication stress
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    Participant Flow

    Recruitment Details Completers included participants who died from any cause and participants who were alive and on study (either on study treatment or in long term follow-up) at study conclusion.
    Pre-assignment Detail Only 169 participants were assigned to one of the 4 cohorts in this study. Data is not available for 3 participants who discontinued before the start of the treatment.
    Arm/Group Title Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Arm/Group Description Participants received 105 milligram per square meter (mg/m²) prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.
    Period Title: Overall Study
    STARTED 53 46 41 29
    Received at Least One Dose of Study Drug 53 46 41 29
    COMPLETED 51 46 38 27
    NOT COMPLETED 2 0 3 2

    Baseline Characteristics

    Arm/Group Title Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4 Total
    Arm/Group Description Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy. Total of all reporting groups
    Overall Participants 53 46 41 29 169
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    61.3
    (9.4)
    62.3
    (9.4)
    59.5
    (8.6)
    59.0
    (13.4)
    60.8
    (10.0)
    Sex: Female, Male (Count of Participants)
    Female
    53
    100%
    46
    100%
    41
    100%
    29
    100%
    169
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    1.9%
    3
    6.5%
    0
    0%
    0
    0%
    4
    2.4%
    Not Hispanic or Latino
    48
    90.6%
    40
    87%
    39
    95.1%
    28
    96.6%
    155
    91.7%
    Unknown or Not Reported
    4
    7.5%
    3
    6.5%
    2
    4.9%
    1
    3.4%
    10
    5.9%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    6
    11.3%
    8
    17.4%
    4
    9.8%
    3
    10.3%
    21
    12.4%
    Native Hawaiian or Other Pacific Islander
    1
    1.9%
    1
    2.2%
    0
    0%
    0
    0%
    2
    1.2%
    Black or African American
    0
    0%
    1
    2.2%
    0
    0%
    1
    3.4%
    2
    1.2%
    White
    46
    86.8%
    36
    78.3%
    37
    90.2%
    25
    86.2%
    144
    85.2%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    South Korea
    4
    7.5%
    5
    10.9%
    2
    4.9%
    2
    6.9%
    13
    7.7%
    Belgium
    4
    7.5%
    1
    2.2%
    3
    7.3%
    0
    0%
    8
    4.7%
    United States
    6
    11.3%
    13
    28.3%
    3
    7.3%
    10
    34.5%
    32
    18.9%
    United Kingdom
    6
    11.3%
    9
    19.6%
    4
    9.8%
    1
    3.4%
    20
    11.8%
    Italy
    4
    7.5%
    4
    8.7%
    8
    19.5%
    7
    24.1%
    23
    13.6%
    Israel
    6
    11.3%
    3
    6.5%
    7
    17.1%
    4
    13.8%
    20
    11.8%
    Australia
    14
    26.4%
    7
    15.2%
    10
    24.4%
    3
    10.3%
    34
    20.1%
    Spain
    9
    17%
    4
    8.7%
    4
    9.8%
    2
    6.9%
    19
    11.2%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
    Description Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100.
    Time Frame Baseline through Disease Progression (Up to 6 months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug.
    Arm/Group Title Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Arm/Group Description Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.
    Measure Participants 53 46 41 29
    Number (95% Confidence Interval) [Percentage of Participants]
    11.3
    21.3%
    13.0
    28.3%
    12.2
    29.8%
    6.9
    23.8%
    2. Secondary Outcome
    Title Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib
    Description Pharmacokinetics(PK): Maximum Plasma Concentration of Prexasertib. The same dose was administered to Cohort 1, 2, 3 and 4 and were combined for analysis.
    Time Frame Cycle 1, Cycle 2, Cycle 4, Cycle 6 (Day 1 (End of prexasertib infusion (+15 min), 1-2 hours following end of prexasertib infusion), Cycle 2, day 1(Prior to start of prexasertib infusion)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable PK data. Cohort 1, 2, 3 and 4 received the same dose and were combined per protocol.
    Arm/Group Title Prexasertib
    Arm/Group Description Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. (Participants combined from all the Cohorts 1 to 4)
    Measure Participants 151
    Cycle 1
    668
    (50)
    Cycle 2
    718
    (62)
    Cycle 4
    678
    (61)
    Cycle 6
    672
    (42)
    3. Secondary Outcome
    Title Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months
    Description DCR is defined as the number of participants who achieve a best overall response of CR, PR or SD for ≥4 months as determined by per RECIST version 1.1. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.
    Time Frame Baseline through Disease Progression (up to 6 months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug.
    Arm/Group Title Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Arm/Group Description Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.
    Measure Participants 53 46 41 29
    Number (95% Confidence Interval) [Percentage of participants]
    45.3
    85.5%
    32.6
    70.9%
    31.7
    77.3%
    31.0
    106.9%
    4. Secondary Outcome
    Title Duration of Response
    Description Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.
    Time Frame Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (up to 20 months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had CR or PR responses. Number of participants censored Cohort 1 = 0, Cohort 2 = 1, Cohort 3 = 0 and Cohort 4 = 0.
    Arm/Group Title Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Arm/Group Description Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.
    Measure Participants 6 5 5 2
    Median (95% Confidence Interval) [Months]
    8.57
    3.84
    5.55
    5.31
    5. Secondary Outcome
    Title Percentage of Participants With at Least a 50% Reduction in CA-125 Levels From Baseline
    Description CA-125 response is defined as ≥50% reduction in CA-125 levels from a pretreatment sample. The response must be confirmed and maintained for ≥28 days according to GCIG criteria. Participants must have a pretreatment sample that is ≥2 times the upper limit of the reference range and obtained within 2 weeks before starting the treatment.
    Time Frame Baseline, 4 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug.
    Arm/Group Title Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Arm/Group Description Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.
    Measure Participants 53 46 41 29
    Number [Percentage of participants]
    39.6
    74.7%
    34.8
    75.7%
    17.1
    41.7%
    37.9
    130.7%
    6. Secondary Outcome
    Title Progression-Free Survival
    Description Progression-Free Survival (PFS) is defined as the time from the date of enrollment until the first occurrence of documented disease progression per RECIST 1.1, or death from any cause in the absence of progressive disease (PD). Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.
    Time Frame Baseline to Disease Progression or Death from any Cause (Up to 22 months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug. Number of participants censored Cohort 1 = 6, Cohort 2 = 4, Cohort 3 = 4 and Cohort 4 = 4.
    Arm/Group Title Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Arm/Group Description Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.
    Measure Participants 47 42 37 25
    Median (95% Confidence Interval) [Months]
    3.91
    3.71
    3.58
    3.71
    7. Secondary Outcome
    Title Overall Survival
    Description Overall survival (OS) is defined as the time from the date of enrollment until death from any cause. If the participant is alive, lost to follow-up or withdrawn from study at the time of data analysis, OS data will be censored on the last date the participant is known to be alive.
    Time Frame Baseline to Date of Death from Any Cause (Up to 26 months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had overall survival data. Number of participants censored Cohort 1 = 18, Cohort 2 = 12, Cohort 3 = 12 and Cohort 4 = 4.
    Arm/Group Title Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Arm/Group Description Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.
    Measure Participants 35 34 29 25
    Median (95% Confidence Interval) [Months]
    13.04
    14.32
    11.14
    8.18

    Adverse Events

    Time Frame Baseline, upto 26 Months
    Adverse Event Reporting Description All randomized participants who received at least one dose.
    Arm/Group Title Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Arm/Group Description Participants received 105 milligram per square meter (mg/m²) prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor. Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.
    All Cause Mortality
    Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/53 (3.8%) 1/46 (2.2%) 1/41 (2.4%) 1/29 (3.4%)
    Serious Adverse Events
    Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 23/53 (43.4%) 17/46 (37%) 19/41 (46.3%) 15/29 (51.7%)
    Blood and lymphatic system disorders
    Anaemia 0/53 (0%) 0 2/46 (4.3%) 2 2/41 (4.9%) 2 2/29 (6.9%) 3
    Febrile neutropenia 5/53 (9.4%) 5 3/46 (6.5%) 4 5/41 (12.2%) 5 4/29 (13.8%) 4
    Leukopenia 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Neutropenia 4/53 (7.5%) 4 3/46 (6.5%) 3 4/41 (9.8%) 4 2/29 (6.9%) 2
    Thrombocytopenia 3/53 (5.7%) 5 0/46 (0%) 0 1/41 (2.4%) 1 1/29 (3.4%) 1
    Cardiac disorders
    Atrioventricular block 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Myocardial infarction 0/53 (0%) 0 0/46 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0
    Pericardial effusion 1/53 (1.9%) 1 0/46 (0%) 0 0/41 (0%) 0 0/29 (0%) 0
    Sinus tachycardia 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Gastrointestinal disorders
    Abdominal pain 0/53 (0%) 0 1/46 (2.2%) 1 1/41 (2.4%) 1 2/29 (6.9%) 2
    Ascites 0/53 (0%) 0 1/46 (2.2%) 1 0/41 (0%) 0 0/29 (0%) 0
    Colitis 1/53 (1.9%) 1 0/46 (0%) 0 0/41 (0%) 0 0/29 (0%) 0
    Constipation 0/53 (0%) 0 2/46 (4.3%) 2 1/41 (2.4%) 1 0/29 (0%) 0
    Diarrhoea 0/53 (0%) 0 2/46 (4.3%) 2 0/41 (0%) 0 0/29 (0%) 0
    Duodenal obstruction 0/53 (0%) 0 1/46 (2.2%) 2 1/41 (2.4%) 1 0/29 (0%) 0
    Gastritis 0/53 (0%) 0 0/46 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0
    Gastrointestinal obstruction 0/53 (0%) 0 0/46 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0
    Gastrooesophageal reflux disease 0/53 (0%) 0 1/46 (2.2%) 1 0/41 (0%) 0 0/29 (0%) 0
    Intestinal obstruction 1/53 (1.9%) 2 0/46 (0%) 0 1/41 (2.4%) 1 1/29 (3.4%) 1
    Large intestinal obstruction 0/53 (0%) 0 1/46 (2.2%) 1 0/41 (0%) 0 0/29 (0%) 0
    Large intestine perforation 2/53 (3.8%) 2 0/46 (0%) 0 0/41 (0%) 0 0/29 (0%) 0
    Nausea 1/53 (1.9%) 2 1/46 (2.2%) 1 2/41 (4.9%) 2 1/29 (3.4%) 1
    Obstruction gastric 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Small intestinal obstruction 1/53 (1.9%) 1 3/46 (6.5%) 3 1/41 (2.4%) 1 2/29 (6.9%) 2
    Vomiting 1/53 (1.9%) 2 4/46 (8.7%) 4 1/41 (2.4%) 1 3/29 (10.3%) 4
    General disorders
    Asthenia 0/53 (0%) 0 0/46 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0
    Chills 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Death 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Generalised oedema 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Hyperpyrexia 1/53 (1.9%) 1 0/46 (0%) 0 0/41 (0%) 0 0/29 (0%) 0
    Non-cardiac chest pain 0/53 (0%) 0 0/46 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0
    Obstruction 0/53 (0%) 0 0/46 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0
    Peripheral swelling 0/53 (0%) 0 1/46 (2.2%) 1 0/41 (0%) 0 0/29 (0%) 0
    Pyrexia 1/53 (1.9%) 1 5/46 (10.9%) 5 1/41 (2.4%) 1 1/29 (3.4%) 1
    Hepatobiliary disorders
    Biliary dilatation 0/53 (0%) 0 0/46 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0
    Infections and infestations
    Diverticulitis 0/53 (0%) 0 1/46 (2.2%) 1 0/41 (0%) 0 0/29 (0%) 0
    Escherichia urinary tract infection 0/53 (0%) 0 1/46 (2.2%) 1 0/41 (0%) 0 0/29 (0%) 0
    Gastroenteritis viral 1/53 (1.9%) 1 0/46 (0%) 0 0/41 (0%) 0 0/29 (0%) 0
    Localised infection 1/53 (1.9%) 1 0/46 (0%) 0 0/41 (0%) 0 0/29 (0%) 0
    Neutropenic sepsis 0/53 (0%) 0 2/46 (4.3%) 2 1/41 (2.4%) 2 1/29 (3.4%) 1
    Pneumonia 1/53 (1.9%) 1 1/46 (2.2%) 2 2/41 (4.9%) 2 2/29 (6.9%) 3
    Sepsis 2/53 (3.8%) 2 1/46 (2.2%) 1 0/41 (0%) 0 2/29 (6.9%) 2
    Septic shock 1/53 (1.9%) 1 0/46 (0%) 0 0/41 (0%) 0 0/29 (0%) 0
    Soft tissue infection 1/53 (1.9%) 1 0/46 (0%) 0 0/41 (0%) 0 0/29 (0%) 0
    Staphylococcal bacteraemia 0/53 (0%) 0 0/46 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0
    Tonsillitis 1/53 (1.9%) 1 0/46 (0%) 0 0/41 (0%) 0 0/29 (0%) 0
    Urinary tract infection 1/53 (1.9%) 1 3/46 (6.5%) 4 0/41 (0%) 0 1/29 (3.4%) 1
    Urosepsis 0/53 (0%) 0 0/46 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0
    Viral infection 0/53 (0%) 0 0/46 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0
    Wound infection 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Injury, poisoning and procedural complications
    Fall 0/53 (0%) 0 1/46 (2.2%) 1 0/41 (0%) 0 0/29 (0%) 0
    Gastrointestinal stoma complication 0/53 (0%) 0 1/46 (2.2%) 1 0/41 (0%) 0 0/29 (0%) 0
    Spinal compression fracture 0/53 (0%) 0 0/46 (0%) 0 1/41 (2.4%) 2 0/29 (0%) 0
    Investigations
    Blood creatinine increased 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Neutrophil count decreased 1/53 (1.9%) 11 0/46 (0%) 0 1/41 (2.4%) 6 1/29 (3.4%) 1
    Platelet count decreased 1/53 (1.9%) 6 0/46 (0%) 0 1/41 (2.4%) 2 0/29 (0%) 0
    Troponin increased 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    White blood cell count increased 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Metabolism and nutrition disorders
    Decreased appetite 1/53 (1.9%) 1 1/46 (2.2%) 1 0/41 (0%) 0 0/29 (0%) 0
    Dehydration 2/53 (3.8%) 2 2/46 (4.3%) 4 0/41 (0%) 0 1/29 (3.4%) 1
    Hypoalbuminaemia 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Musculoskeletal and connective tissue disorders
    Back pain 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Nervous system disorders
    Encephalopathy 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Product Issues
    Device dislocation 0/53 (0%) 0 1/46 (2.2%) 1 0/41 (0%) 0 0/29 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 1/29 (3.4%) 1
    Pollakiuria 0/53 (0%) 0 0/46 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0
    Urinary tract obstruction 1/53 (1.9%) 1 0/46 (0%) 0 0/41 (0%) 0 0/29 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 2/53 (3.8%) 2 0/46 (0%) 0 0/41 (0%) 0 0/29 (0%) 0
    Hypoxia 0/53 (0%) 0 1/46 (2.2%) 1 0/41 (0%) 0 0/29 (0%) 0
    Pleuritic pain 0/53 (0%) 0 0/46 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0
    Pulmonary embolism 1/53 (1.9%) 1 0/46 (0%) 0 0/41 (0%) 0 0/29 (0%) 0
    Vascular disorders
    Hypertension 0/53 (0%) 0 0/46 (0%) 0 1/41 (2.4%) 1 0/29 (0%) 0
    Peripheral artery thrombosis 0/53 (0%) 0 1/46 (2.2%) 1 0/41 (0%) 0 0/29 (0%) 0
    Other (Not Including Serious) Adverse Events
    Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 53/53 (100%) 44/46 (95.7%) 39/41 (95.1%) 28/29 (96.6%)
    Blood and lymphatic system disorders
    Anaemia 20/53 (37.7%) 64 17/46 (37%) 38 15/41 (36.6%) 40 12/29 (41.4%) 26
    Febrile neutropenia 1/53 (1.9%) 1 0/46 (0%) 0 2/41 (4.9%) 2 3/29 (10.3%) 3
    Leukopenia 4/53 (7.5%) 7 1/46 (2.2%) 2 6/41 (14.6%) 10 4/29 (13.8%) 7
    Neutropenia 19/53 (35.8%) 40 10/46 (21.7%) 26 11/41 (26.8%) 24 10/29 (34.5%) 15
    Thrombocytopenia 17/53 (32.1%) 83 14/46 (30.4%) 36 14/41 (34.1%) 34 7/29 (24.1%) 18
    Gastrointestinal disorders
    Abdominal discomfort 3/53 (5.7%) 3 2/46 (4.3%) 3 0/41 (0%) 0 2/29 (6.9%) 3
    Abdominal distension 4/53 (7.5%) 4 3/46 (6.5%) 3 2/41 (4.9%) 2 5/29 (17.2%) 7
    Abdominal pain 14/53 (26.4%) 18 18/46 (39.1%) 40 11/41 (26.8%) 15 10/29 (34.5%) 14
    Abdominal pain lower 1/53 (1.9%) 1 2/46 (4.3%) 4 3/41 (7.3%) 3 1/29 (3.4%) 1
    Abdominal pain upper 3/53 (5.7%) 3 4/46 (8.7%) 6 2/41 (4.9%) 2 4/29 (13.8%) 4
    Ascites 1/53 (1.9%) 1 5/46 (10.9%) 11 2/41 (4.9%) 3 2/29 (6.9%) 3
    Constipation 13/53 (24.5%) 19 12/46 (26.1%) 15 8/41 (19.5%) 13 5/29 (17.2%) 5
    Diarrhoea 19/53 (35.8%) 57 15/46 (32.6%) 19 7/41 (17.1%) 11 8/29 (27.6%) 20
    Dry mouth 0/53 (0%) 0 3/46 (6.5%) 3 0/41 (0%) 0 0/29 (0%) 0
    Dyspepsia 3/53 (5.7%) 3 2/46 (4.3%) 4 4/41 (9.8%) 4 0/29 (0%) 0
    Mouth ulceration 3/53 (5.7%) 5 1/46 (2.2%) 1 1/41 (2.4%) 1 0/29 (0%) 0
    Nausea 19/53 (35.8%) 54 24/46 (52.2%) 56 15/41 (36.6%) 33 16/29 (55.2%) 25
    Small intestinal obstruction 3/53 (5.7%) 4 2/46 (4.3%) 2 1/41 (2.4%) 2 4/29 (13.8%) 5
    Vomiting 21/53 (39.6%) 29 13/46 (28.3%) 20 11/41 (26.8%) 36 14/29 (48.3%) 25
    General disorders
    Asthenia 8/53 (15.1%) 19 8/46 (17.4%) 16 10/41 (24.4%) 38 4/29 (13.8%) 13
    Catheter site pain 0/53 (0%) 0 1/46 (2.2%) 1 1/41 (2.4%) 1 2/29 (6.9%) 2
    Fatigue 21/53 (39.6%) 84 19/46 (41.3%) 37 12/41 (29.3%) 17 12/29 (41.4%) 20
    Mucosal inflammation 5/53 (9.4%) 8 1/46 (2.2%) 1 3/41 (7.3%) 5 1/29 (3.4%) 1
    Non-cardiac chest pain 0/53 (0%) 0 1/46 (2.2%) 1 3/41 (7.3%) 6 1/29 (3.4%) 1
    Oedema peripheral 4/53 (7.5%) 5 3/46 (6.5%) 3 3/41 (7.3%) 3 1/29 (3.4%) 1
    Pain 4/53 (7.5%) 4 2/46 (4.3%) 3 5/41 (12.2%) 6 3/29 (10.3%) 3
    Pyrexia 13/53 (24.5%) 17 5/46 (10.9%) 6 7/41 (17.1%) 16 8/29 (27.6%) 9
    Infections and infestations
    Cellulitis 3/53 (5.7%) 3 0/46 (0%) 0 0/41 (0%) 0 0/29 (0%) 0
    Nasopharyngitis 1/53 (1.9%) 1 3/46 (6.5%) 3 3/41 (7.3%) 3 1/29 (3.4%) 1
    Upper respiratory tract infection 7/53 (13.2%) 9 2/46 (4.3%) 2 0/41 (0%) 0 1/29 (3.4%) 1
    Urinary tract infection 4/53 (7.5%) 9 3/46 (6.5%) 5 0/41 (0%) 0 4/29 (13.8%) 4
    Viral infection 3/53 (5.7%) 3 0/46 (0%) 0 2/41 (4.9%) 4 0/29 (0%) 0
    Injury, poisoning and procedural complications
    Fall 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 2/29 (6.9%) 2
    Infusion related reaction 5/53 (9.4%) 5 6/46 (13%) 9 4/41 (9.8%) 5 2/29 (6.9%) 2
    Investigations
    Alanine aminotransferase increased 1/53 (1.9%) 1 3/46 (6.5%) 3 3/41 (7.3%) 4 2/29 (6.9%) 3
    Aspartate aminotransferase increased 2/53 (3.8%) 3 3/46 (6.5%) 3 1/41 (2.4%) 1 2/29 (6.9%) 3
    Blood alkaline phosphatase increased 2/53 (3.8%) 2 3/46 (6.5%) 3 0/41 (0%) 0 1/29 (3.4%) 1
    Blood creatinine increased 3/53 (5.7%) 4 2/46 (4.3%) 2 3/41 (7.3%) 5 0/29 (0%) 0
    Neutrophil count decreased 2/53 (3.8%) 11 9/46 (19.6%) 13 5/41 (12.2%) 9 1/29 (3.4%) 1
    Platelet count decreased 8/53 (15.1%) 37 7/46 (15.2%) 17 7/41 (17.1%) 28 3/29 (10.3%) 4
    Weight decreased 2/53 (3.8%) 2 3/46 (6.5%) 4 1/41 (2.4%) 1 2/29 (6.9%) 2
    White blood cell count decreased 1/53 (1.9%) 1 3/46 (6.5%) 7 1/41 (2.4%) 1 0/29 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 12/53 (22.6%) 14 12/46 (26.1%) 21 9/41 (22%) 12 7/29 (24.1%) 8
    Dehydration 0/53 (0%) 0 1/46 (2.2%) 1 0/41 (0%) 0 2/29 (6.9%) 2
    Hypoalbuminaemia 0/53 (0%) 0 3/46 (6.5%) 3 1/41 (2.4%) 2 0/29 (0%) 0
    Hypokalaemia 3/53 (5.7%) 4 2/46 (4.3%) 11 5/41 (12.2%) 10 1/29 (3.4%) 1
    Hypomagnesaemia 2/53 (3.8%) 3 3/46 (6.5%) 12 2/41 (4.9%) 4 2/29 (6.9%) 2
    Hyponatraemia 4/53 (7.5%) 6 3/46 (6.5%) 3 3/41 (7.3%) 6 0/29 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 8/53 (15.1%) 11 5/46 (10.9%) 6 2/41 (4.9%) 2 0/29 (0%) 0
    Back pain 11/53 (20.8%) 13 8/46 (17.4%) 14 6/41 (14.6%) 7 6/29 (20.7%) 7
    Bone pain 3/53 (5.7%) 4 0/46 (0%) 0 3/41 (7.3%) 4 3/29 (10.3%) 3
    Groin pain 0/53 (0%) 0 1/46 (2.2%) 1 0/41 (0%) 0 2/29 (6.9%) 3
    Muscle spasms 3/53 (5.7%) 13 2/46 (4.3%) 2 2/41 (4.9%) 3 1/29 (3.4%) 1
    Muscular weakness 0/53 (0%) 0 5/46 (10.9%) 5 0/41 (0%) 0 1/29 (3.4%) 1
    Myalgia 1/53 (1.9%) 2 3/46 (6.5%) 4 1/41 (2.4%) 1 0/29 (0%) 0
    Nervous system disorders
    Dizziness 1/53 (1.9%) 1 5/46 (10.9%) 8 1/41 (2.4%) 1 4/29 (13.8%) 4
    Headache 8/53 (15.1%) 9 10/46 (21.7%) 21 3/41 (7.3%) 7 1/29 (3.4%) 1
    Neuropathy peripheral 2/53 (3.8%) 2 3/46 (6.5%) 4 0/41 (0%) 0 0/29 (0%) 0
    Psychiatric disorders
    Anxiety 2/53 (3.8%) 2 0/46 (0%) 0 0/41 (0%) 0 2/29 (6.9%) 3
    Insomnia 0/53 (0%) 0 3/46 (6.5%) 3 2/41 (4.9%) 2 4/29 (13.8%) 4
    Renal and urinary disorders
    Pollakiuria 0/53 (0%) 0 1/46 (2.2%) 1 0/41 (0%) 0 2/29 (6.9%) 2
    Reproductive system and breast disorders
    Pelvic pain 3/53 (5.7%) 5 0/46 (0%) 0 3/41 (7.3%) 3 0/29 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 5/53 (9.4%) 8 2/46 (4.3%) 2 4/41 (9.8%) 4 1/29 (3.4%) 1
    Dyspnoea 6/53 (11.3%) 10 7/46 (15.2%) 8 4/41 (9.8%) 5 4/29 (13.8%) 4
    Oropharyngeal pain 5/53 (9.4%) 6 2/46 (4.3%) 2 3/41 (7.3%) 3 0/29 (0%) 0
    Skin and subcutaneous tissue disorders
    Erythema 0/53 (0%) 0 0/46 (0%) 0 0/41 (0%) 0 2/29 (6.9%) 2
    Pruritus 5/53 (9.4%) 5 3/46 (6.5%) 3 2/41 (4.9%) 3 1/29 (3.4%) 1
    Rash 3/53 (5.7%) 3 5/46 (10.9%) 9 6/41 (14.6%) 7 2/29 (6.9%) 2
    Vascular disorders
    Flushing 1/53 (1.9%) 1 1/46 (2.2%) 1 2/41 (4.9%) 3 2/29 (6.9%) 2
    Hot flush 0/53 (0%) 0 1/46 (2.2%) 4 3/41 (7.3%) 3 0/29 (0%) 0
    Hypertension 5/53 (9.4%) 5 2/46 (4.3%) 2 3/41 (7.3%) 4 1/29 (3.4%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03414047
    Other Study ID Numbers:
    • 16712
    • I4D-MC-JTJN
    • 2017-004009-42
    First Posted:
    Jan 29, 2018
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022