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A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02735980
Collaborator
(none)
133
Enrollment
41
Locations
3
Arms
33.1
Actual Duration (Months)
3.2
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 safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. The study will also evaluate the association between tumor response and the participant's perceived quality of life.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
133 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer
Actual Study Start Date :
May 11, 2016
Actual Primary Completion Date :
Jul 31, 2017
Actual Study Completion Date :
Feb 12, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prexasertib (Platinum Sensitive Disease)

105 mg/m^2 Intravenous (IV) prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had platinum-sensitive disease (has prior platinum based therapy with subsequent progression greater or less than 90 days after last dose of platinum based therapy).

Drug: Prexasertib
Administered IV
Other Names:
  • LY2606368

    		•
    Experimental: Prexasertib (Platinum Resistant Disease)

    105 mg/m^2 IV prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had resistant/refractory disease (did not have an objective response to platinum-based therapy or had progression greater than 90 days after the last dose of platinum).

    Drug: Prexasertib
    Administered IV
    Other Names:
  • LY2606368

    		•
    Experimental: Prexasertib Exploratory Addendum (Platinum Sensitive Disease)

    40 mg/m^2 IV prexasertib Day 1, 2, and Day 3 of a 14 day cycle in participants with ED-SCLC platinum sensitive disease.

    Drug: Prexasertib
    Administered IV
    Other Names:
  • LY2606368

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) [Baseline to 10 months]

      ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions

    Secondary Outcome Measures

    1. Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2 [Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime]

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

    2. Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda) [Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime]

      Pharmacokinetics(PK): Maximum Concentration of Prexasertib

    3. Pharmacokinetics: Area Under the Concentration Curve of Prexasertib [Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime]

      Pharmacokinetics: Area Under the Concentration Curve of Prexasertib

    4. Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) [Baseline through Disease Progression or Death from Any Cause to 28 months]

      Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD.

    5. Progression-Free Survival (PFS) [Baseline to Disease Progression or Death (up to 9 months)]

      PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

    6. Duration of Response (DoR) [Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 months]

      DoR the time from the date of an objective response until Progressive Disease (PD): was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

    7. Overall Survival (OS) [Baseline up to 28 months]

      OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.

    8. Change From Baseline in Lung Cancer Symptom Scale Score (LCSS) [Baseline up to 9 months]

      LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).

    9. Change From Baseline on the Average Symptom Burden Index (ASBI) [Baseline up to 9 months]

      ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).

    Eligibility Criteria

    Criteria

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

    • Have ED-SCLC and have received a prior platinum-based regimen

    • Participants in Cohort 1 and in the addendum must have had an objective response to prior platinum-based therapy with subsequent progression ≥90 days after the last dose of platinum

    • Participants in Cohort 2 must have either not had an objective response to prior platinum based therapy or had progression <90 days after the last dose of platinum

    • Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale

    Exclusion Criteria:

    • Have received more than 2 prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy)

    • Have symptomatic central nervous system (CNS) malignancy or metastasis. Asymptomatic participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids to treat CNS metastases

    • Have previously completed or withdrawn from this study or any other study investigating prexasertib or a checkpoint kinase I (CHK1) inhibitor or have shown hypersensitivity to any of the components of the prexasertib formulation

    • Have a serious cardiac condition

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Highlands Oncology Group Fayetteville Arkansas United States 72703
    2 Yale University School of Medicine New Haven Connecticut United States 06520
    3 Georgetown University Medical Center Washington District of Columbia United States 20007
    4 Florida Cancer Specialists Fort Myers Florida United States 33908
    5 Florida Cancer Specialists and Research Institute Saint Petersburg Florida United States 33705
    6 Massachusetts General Hospital Danvers Massachusetts United States 01923
    7 Washington University Medical Center Saint Louis Missouri United States 63110
    8 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756-0001
    9 Chattanooga Oncology Hematology Associates Chattanooga Tennessee United States 37404
    10 Sarah Cannon Cancer Center Nashville Tennessee United States 37203
    11 Tennessee Oncology PLLC Nashville Tennessee United States 37203
    12 Vanderbilt University Medical Center Nashville Tennessee United States 37232-6307
    13 The Center for Cancer and Blood Disorders Fort Worth Texas United States 76104
    14 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Besancon Cedex France 25030
    16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lille France 59037
    17 "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician." Montpellier France 34070
    18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vantoux France 57070
    19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Halle Germany 06120
    20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Athens Greece 11527
    21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Heraklion Greece 71110
    22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Patras Greece 26504
    23 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. Seoul Korea, Republic of 06351
    24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Seoul Korea, Republic of 120-792
    25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Amsterdam Netherlands 1066 CX
    26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Breda Netherlands 4818 CK
    27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zwolle Netherlands 8025 AB
    28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Barcelona Spain 08035
    29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Madrid Spain 28034
    30 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zaragoza Spain 50009
    31 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Antalya Turkey 07059
    32 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Edirne Turkey
    33 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Istanbul Turkey 34098
    34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Izmir Turkey 35100
    35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kayseri Turkey 38039
    36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dnipropetrovsk Ukraine 49102
    37 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kharkiv Ukraine 61070
    38 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sumy Ukraine 40005
    39 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Headington United Kingdom OX3 7LJ
    40 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Leicester United Kingdom LE1 5WN
    41 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sheffield United Kingdom S10 2SJ

    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:
    NCT02735980
    Other Study ID Numbers:
    • 16015
    • I4D-MC-JTJH
    • 2015-005069-21
    First Posted:
    Apr 13, 2016
    Last Update Posted:
    Mar 17, 2020
    Last Verified:
    May 1, 2019
    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
    SCLC
    LY2606368
    CHK1
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 105 mg/m^2 Prexasertib (Platinum Sensitive Disease) 105 mg/m^2 Prexasertib (Platinum Resistant Disease) 40 mg/m2 Prexasertib Exploratory Addendum
    Arm/Group Description Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle 40 mg/m2 IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
    Period Title: Overall Study
    STARTED 58 60 15
    Received at Least 1 Dose of Study Drug 56 60 15
    COMPLETED 48 49 14
    NOT COMPLETED 10 11 1

    Baseline Characteristics

    Arm/Group Title Prexasertib (Platinum Sensitive Disease) Prexasertib (Platinum Resistant Disease) Prexasertib Exploratory Addendum (Platinum Sensitive Disease) Total
    Arm/Group Description Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle Total of all reporting groups
    Overall Participants 58 60 15 133
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    64.17
    (9.21)
    61.45
    (7.20)
    61.67
    (7.33)
    62.66
    (8.20)
    Sex: Female, Male (Count of Participants)
    Female
    23
    39.7%
    10
    16.7%
    4
    26.7%
    37
    27.8%
    Male
    35
    60.3%
    50
    83.3%
    11
    73.3%
    96
    72.2%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    52
    89.7%
    53
    88.3%
    15
    100%
    120
    90.2%
    Unknown or Not Reported
    6
    10.3%
    6
    10%
    0
    0%
    12
    9%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    2
    3.4%
    8
    13.3%
    2
    13.3%
    12
    9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    2
    3.4%
    1
    1.7%
    0
    0%
    3
    2.3%
    White
    50
    86.2%
    47
    78.3%
    13
    86.7%
    110
    82.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    Greece
    4
    6.9%
    4
    6.7%
    0
    0%
    8
    6%
    Netherlands
    5
    8.6%
    1
    1.7%
    0
    0%
    6
    4.5%
    South Korea
    0
    0%
    8
    13.3%
    0
    0%
    8
    6%
    Turkey
    6
    10.3%
    15
    25%
    0
    0%
    21
    15.8%
    United States
    24
    41.4%
    12
    20%
    9
    60%
    45
    33.8%
    Ukraine
    1
    1.7%
    7
    11.7%
    0
    0%
    8
    6%
    United Kingdom
    2
    3.4%
    0
    0%
    0
    0%
    2
    1.5%
    France
    7
    12.1%
    5
    8.3%
    0
    0%
    12
    9%
    Germany
    0
    0%
    2
    3.3%
    0
    0%
    2
    1.5%
    Spain
    9
    15.5%
    6
    10%
    6
    40%
    21
    15.8%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
    Description ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions
    Time Frame Baseline to 10 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Prexasertib (Platinum Sensitive Disease) Prexasertib (Platinum Resistant Disease) Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
    Arm/Group Description Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
    Measure Participants 58 60 15
    Number (95% Confidence Interval) [percentage of participants]
    5.2
    9%
    0
    0%
    0
    0%
    2. Secondary Outcome
    Title Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2
    Description Pharmacokinetics(PK): Maximum Concentration of Prexasertib. The same dose was administered to Cohort 1 and Cohort 2 and were combined for analysis.
    Time Frame Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug and had evaluable PK parameters. Cohort 1 and Cohort 2 received the same dose and were combined per protocol.
    Arm/Group Title 105 mg/m^2 Prexasertib
    Arm/Group Description IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
    Measure Participants 99
    Cycle 1
    722
    (64)
    Cycle 3
    735
    (71)
    Cycle 5
    732
    (69)
    Cycle 7
    1230
    (22)
    3. Secondary Outcome
    Title Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda)
    Description Pharmacokinetics(PK): Maximum Concentration of Prexasertib
    Time Frame Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime

    Outcome Measure Data

    Analysis Population Description
    Al randomized participants with at least 1 dose of study drug, received 40 mg/m^2 and had evaluable PK parameters.
    Arm/Group Title 40 mg/m2 Prexasertib Exploratory Addendum
    Arm/Group Description 40 mg/m2 IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
    Measure Participants 15
    Geometric Mean (Geometric Coefficient of Variation) [nanograms per milliliter]
    227
    (68)
    4. Secondary Outcome
    Title Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
    Description Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
    Time Frame Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime

    Outcome Measure Data

    Analysis Population Description
    All participants in Part A1 that received at least 1 dose of study drug and had evaluable PK data.
    Arm/Group Title Cohort 1 Prexasertib (Platinum Sensitive Disease) Cohort 2 Prexasertib (Platinum Resistant Disease) Cohort 3 Prexasertib Exploratory(Platinum Sensitive Disease)
    Arm/Group Description Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
    Measure Participants 56 60 15
    Geometric Mean (Geometric Coefficient of Variation) [mg*h/mL]
    126
    (154)
    1190
    (95)
    1840
    (35)
    5. Secondary Outcome
    Title Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)
    Description Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD.
    Time Frame Baseline through Disease Progression or Death from Any Cause to 28 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Cohort 1 Prexasertib (Platinum Sensitive Disease) Cohort 2 Prexasertib (Platinum Resistant Disease) Cohort 3 Prexasertib Exploratory(Platinum Sensitive Disease)
    Arm/Group Description Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
    Measure Participants 58 60 15
    Number (95% Confidence Interval) [percentage of participants]
    31
    53.4%
    20.0
    33.3%
    40.0
    266.7%
    6. Secondary Outcome
    Title Progression-Free Survival (PFS)
    Description PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
    Time Frame Baseline to Disease Progression or Death (up to 9 months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. 4 participants were censored from Prexasertib Cohort 1 and 1 participant from Prexasertib Cohort 3.
    Arm/Group Title Prexasertib (Platinum Sensitive Disease) Prexasertib (Platinum Resistant Disease) Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
    Arm/Group Description Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
    Measure Participants 58 60 15
    Median (95% Confidence Interval) [months]
    1.41
    1.36
    1.58
    7. Secondary Outcome
    Title Duration of Response (DoR)
    Description DoR the time from the date of an objective response until Progressive Disease (PD): was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
    Time Frame Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was not performed due to only 3 responders in Cohort 1, no in Cohort 2 or 3. Individual data for Cohort 1 is presented.
    Arm/Group Title Cohort 1 Prexasertib (Platinum Sensitive Disease) Cohort 2 Prexasertib (Platinum Resistant Disease) Cohort 3 Prexasertib Exploratory(Platinum Sensitive Disease)
    Arm/Group Description Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
    Measure Participants 58 60 15
    Number [days]
    NA
    NA
    NA
    8. Secondary Outcome
    Title Overall Survival (OS)
    Description OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
    Time Frame Baseline up to 28 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. 8 participants were censored from Cohort 1, 5 participants were censored from Cohort 2 and 4 participants censored from Cohort 3.
    Arm/Group Title Cohort 1 Prexasertib (Platinum Sensitive Disease) Cohort 2 Prexasertib (Platinum Resistant Disease) Cohort 3 Prexasertib Exploratory(Platinum Sensitive Disease)
    Arm/Group Description Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
    Measure Participants 58 60 15
    Median (95% Confidence Interval) [months]
    5.42
    3.15
    7.26
    9. Secondary Outcome
    Title Change From Baseline in Lung Cancer Symptom Scale Score (LCSS)
    Description LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).
    Time Frame Baseline up to 9 months

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort 1 and Cohort 2. Cohort 3 was added by protocol addendum and data were not collected with non missing baseline and post baseline scores.
    Arm/Group Title Cohort 1 Prexasertib (Platinum Sensitive Disease) Cohort 2 Prexasertib (Platinum Resistant Disease)
    Arm/Group Description Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
    Measure Participants 58 60
    Mean (Standard Deviation) [units on a scale]
    -2.8
    (12.3)
    -4.0
    (10.2)
    10. Secondary Outcome
    Title Change From Baseline on the Average Symptom Burden Index (ASBI)
    Description ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).
    Time Frame Baseline up to 9 months

    Outcome Measure Data

    Analysis Population Description
    All participants in Cohort 1 and Cohort 2. Cohort 3 was added by protocol addendum and data were not collected with non missing baseline and post baseline scores.
    Arm/Group Title Cohort 1 Prexasertib (Platinum Sensitive Disease) Cohort 2 Prexasertib (Platinum Resistant Disease)
    Arm/Group Description Intravenous (IV) prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
    Measure Participants 58 60
    Mean (Standard Deviation) [units on a scale]
    -3.0
    (11.9)
    -4.4
    (11.1)

    Adverse Events

    Time Frame up to 28 months
    Adverse Event Reporting Description All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title 105 mg/m^2 Prexasertib (Platinum Sensitive Disease) 105 mg/m^2 Prexasertib (Platinum Resistant Disease) 40 mg/m2 Prexasertib Exploratory Addendum
    Arm/Group Description Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle IV 40 mg/m2 prexasertib (LY2606368) IV administered on Days 1, 2 and 3 of a 14-day cycle
    All Cause Mortality
    105 mg/m^2 Prexasertib (Platinum Sensitive Disease) 105 mg/m^2 Prexasertib (Platinum Resistant Disease) 40 mg/m2 Prexasertib Exploratory Addendum
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/56 (17.9%) 7/60 (11.7%) 11/15 (73.3%)
    Serious Adverse Events
    105 mg/m^2 Prexasertib (Platinum Sensitive Disease) 105 mg/m^2 Prexasertib (Platinum Resistant Disease) 40 mg/m2 Prexasertib Exploratory Addendum
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 21/56 (37.5%) 16/60 (26.7%) 6/15 (40%)
    Blood and lymphatic system disorders
    Anaemia 0/56 (0%) 0 2/60 (3.3%) 2 0/15 (0%) 0
    Febrile neutropenia 8/56 (14.3%) 9 1/60 (1.7%) 1 2/15 (13.3%) 3
    Leukopenia 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Neutropenia 1/56 (1.8%) 1 1/60 (1.7%) 2 1/15 (6.7%) 1
    Thrombocytopenia 2/56 (3.6%) 2 1/60 (1.7%) 2 0/15 (0%) 0
    Cardiac disorders
    Pericardial effusion 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 0/56 (0%) 0 1/60 (1.7%) 1 1/15 (6.7%) 1
    Ascites 0/56 (0%) 0 1/60 (1.7%) 1 0/15 (0%) 0
    Colitis ischaemic 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Diarrhoea 0/56 (0%) 0 1/60 (1.7%) 1 0/15 (0%) 0
    Stomatitis 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Vomiting 0/56 (0%) 0 1/60 (1.7%) 1 0/15 (0%) 0
    General disorders
    Fatigue 2/56 (3.6%) 2 0/60 (0%) 0 0/15 (0%) 0
    Multiple organ dysfunction syndrome 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Pain 0/56 (0%) 0 1/60 (1.7%) 1 0/15 (0%) 0
    Infections and infestations
    Bronchitis 2/56 (3.6%) 2 1/60 (1.7%) 1 1/15 (6.7%) 1
    Device related infection 0/56 (0%) 0 1/60 (1.7%) 1 0/15 (0%) 0
    Escherichia bacteraemia 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Parainfluenzae virus infection 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Pneumonia 5/56 (8.9%) 9 0/60 (0%) 0 2/15 (13.3%) 3
    Pneumonia haemophilus 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Sepsis 3/56 (5.4%) 3 1/60 (1.7%) 1 0/15 (0%) 0
    Urinary tract infection 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Injury, poisoning and procedural complications
    Subdural haematoma 0/56 (0%) 0 0/60 (0%) 0 1/15 (6.7%) 1
    Investigations
    Blood bilirubin increased 0/56 (0%) 0 1/60 (1.7%) 1 0/15 (0%) 0
    Blood creatinine increased 0/56 (0%) 0 1/60 (1.7%) 1 0/15 (0%) 0
    Electrocardiogram qt prolonged 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Neutrophil count decreased 1/56 (1.8%) 1 1/60 (1.7%) 1 0/15 (0%) 0
    Platelet count decreased 0/56 (0%) 0 4/60 (6.7%) 7 0/15 (0%) 0
    White blood cell count decreased 0/56 (0%) 0 1/60 (1.7%) 1 0/15 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 2/56 (3.6%) 2 0/60 (0%) 0 0/15 (0%) 0
    Dehydration 1/56 (1.8%) 1 1/60 (1.7%) 1 0/15 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 0/56 (0%) 0 1/60 (1.7%) 1 0/15 (0%) 0
    Muscular weakness 0/56 (0%) 0 0/60 (0%) 0 1/15 (6.7%) 1
    Nervous system disorders
    Cauda equina syndrome 0/56 (0%) 0 1/60 (1.7%) 1 0/15 (0%) 0
    Encephalopathy 1/56 (1.8%) 2 0/60 (0%) 0 0/15 (0%) 0
    Lethargy 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Psychiatric disorders
    Confusional state 1/56 (1.8%) 1 1/60 (1.7%) 1 0/15 (0%) 0
    Mental status changes 2/56 (3.6%) 2 0/60 (0%) 0 0/15 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 0/56 (0%) 0 1/60 (1.7%) 1 0/15 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Atelectasis 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Dyspnoea 0/56 (0%) 0 4/60 (6.7%) 4 0/15 (0%) 0
    Epistaxis 0/56 (0%) 0 1/60 (1.7%) 1 0/15 (0%) 0
    Haemoptysis 0/56 (0%) 0 2/60 (3.3%) 3 0/15 (0%) 0
    Pneumothorax 0/56 (0%) 0 0/60 (0%) 0 1/15 (6.7%) 1
    Productive cough 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Pulmonary embolism 0/56 (0%) 0 1/60 (1.7%) 1 0/15 (0%) 0
    Respiratory failure 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Vascular disorders
    Deep vein thrombosis 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Hypotension 1/56 (1.8%) 2 1/60 (1.7%) 1 0/15 (0%) 0
    Orthostatic hypotension 1/56 (1.8%) 1 0/60 (0%) 0 0/15 (0%) 0
    Other (Not Including Serious) Adverse Events
    105 mg/m^2 Prexasertib (Platinum Sensitive Disease) 105 mg/m^2 Prexasertib (Platinum Resistant Disease) 40 mg/m2 Prexasertib Exploratory Addendum
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 56/56 (100%) 59/60 (98.3%) 15/15 (100%)
    Blood and lymphatic system disorders
    Anaemia 28/56 (50%) 46 20/60 (33.3%) 36 9/15 (60%) 30
    Febrile neutropenia 5/56 (8.9%) 5 0/60 (0%) 0 1/15 (6.7%) 1
    Leukopenia 3/56 (5.4%) 4 6/60 (10%) 11 0/15 (0%) 0
    Neutropenia 18/56 (32.1%) 30 18/60 (30%) 39 4/15 (26.7%) 11
    Thrombocytopenia 13/56 (23.2%) 27 9/60 (15%) 27 4/15 (26.7%) 11
    Cardiac disorders
    Acute myocardial infarction 0/56 (0%) 0 0/60 (0%) 0 1/15 (6.7%) 1
    Eye disorders
    Eye haematoma 0/56 (0%) 0 0/60 (0%) 0 1/15 (6.7%) 1
    Gastrointestinal disorders
    Abdominal pain 1/56 (1.8%) 1 2/60 (3.3%) 2 1/15 (6.7%) 1
    Constipation 7/56 (12.5%) 9 6/60 (10%) 6 1/15 (6.7%) 1
    Diarrhoea 10/56 (17.9%) 14 5/60 (8.3%) 12 3/15 (20%) 3
    Nausea 15/56 (26.8%) 17 12/60 (20%) 16 3/15 (20%) 3
    Stomatitis 3/56 (5.4%) 4 2/60 (3.3%) 2 3/15 (20%) 3
    Vomiting 8/56 (14.3%) 11 7/60 (11.7%) 11 3/15 (20%) 3
    General disorders
    Asthenia 8/56 (14.3%) 9 5/60 (8.3%) 7 2/15 (13.3%) 9
    Catheter site pain 1/56 (1.8%) 1 0/60 (0%) 0 1/15 (6.7%) 1
    Fatigue 16/56 (28.6%) 25 18/60 (30%) 25 6/15 (40%) 8
    Influenza like illness 0/56 (0%) 0 0/60 (0%) 0 2/15 (13.3%) 2
    Non-cardiac chest pain 7/56 (12.5%) 8 5/60 (8.3%) 5 0/15 (0%) 0
    Oedema peripheral 4/56 (7.1%) 5 1/60 (1.7%) 1 1/15 (6.7%) 1
    Pyrexia 4/56 (7.1%) 4 5/60 (8.3%) 7 3/15 (20%) 3
    Infections and infestations
    Oral candidiasis 2/56 (3.6%) 2 0/60 (0%) 0 1/15 (6.7%) 1
    Oral herpes 0/56 (0%) 0 0/60 (0%) 0 1/15 (6.7%) 1
    Pharyngitis 1/56 (1.8%) 1 0/60 (0%) 0 1/15 (6.7%) 1
    Rhinitis 0/56 (0%) 0 0/60 (0%) 0 1/15 (6.7%) 1
    Tooth infection 1/56 (1.8%) 1 0/60 (0%) 0 1/15 (6.7%) 1
    Urinary tract infection 3/56 (5.4%) 3 2/60 (3.3%) 2 1/15 (6.7%) 1
    Investigations
    Alanine aminotransferase increased 2/56 (3.6%) 3 4/60 (6.7%) 8 2/15 (13.3%) 2
    Aspartate aminotransferase increased 3/56 (5.4%) 3 5/60 (8.3%) 5 2/15 (13.3%) 2
    Blood cholesterol increased 0/56 (0%) 0 0/60 (0%) 0 1/15 (6.7%) 1
    Blood creatinine increased 1/56 (1.8%) 4 4/60 (6.7%) 5 0/15 (0%) 0
    Blood uric acid increased 0/56 (0%) 0 0/60 (0%) 0 1/15 (6.7%) 1
    Electrocardiogram qt prolonged 0/56 (0%) 0 0/60 (0%) 0 1/15 (6.7%) 1
    Gamma-glutamyltransferase increased 2/56 (3.6%) 5 5/60 (8.3%) 6 0/15 (0%) 0
    Lipase increased 0/56 (0%) 0 0/60 (0%) 0 1/15 (6.7%) 1
    Lymphocyte count decreased 7/56 (12.5%) 18 6/60 (10%) 16 3/15 (20%) 5
    Neutrophil count decreased 23/56 (41.1%) 62 26/60 (43.3%) 68 7/15 (46.7%) 38
    Platelet count decreased 18/56 (32.1%) 49 23/60 (38.3%) 44 9/15 (60%) 36
    Weight decreased 5/56 (8.9%) 5 3/60 (5%) 6 1/15 (6.7%) 1
    White blood cell count decreased 14/56 (25%) 34 18/60 (30%) 59 5/15 (33.3%) 9
    Metabolism and nutrition disorders
    Decreased appetite 13/56 (23.2%) 18 14/60 (23.3%) 20 6/15 (40%) 7
    Dehydration 6/56 (10.7%) 7 2/60 (3.3%) 3 1/15 (6.7%) 2
    Hyperuricaemia 3/56 (5.4%) 4 2/60 (3.3%) 3 0/15 (0%) 0
    Hypokalaemia 4/56 (7.1%) 4 3/60 (5%) 7 2/15 (13.3%) 2
    Hypomagnesaemia 3/56 (5.4%) 3 2/60 (3.3%) 2 0/15 (0%) 0
    Hyponatraemia 4/56 (7.1%) 5 2/60 (3.3%) 2 1/15 (6.7%) 5
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/56 (1.8%) 1 3/60 (5%) 3 2/15 (13.3%) 3
    Back pain 7/56 (12.5%) 7 5/60 (8.3%) 6 0/15 (0%) 0
    Bone pain 3/56 (5.4%) 5 1/60 (1.7%) 2 0/15 (0%) 0
    Muscular weakness 0/56 (0%) 0 3/60 (5%) 3 2/15 (13.3%) 2
    Myalgia 1/56 (1.8%) 1 1/60 (1.7%) 1 1/15 (6.7%) 2
    Pain in extremity 3/56 (5.4%) 4 4/60 (6.7%) 5 0/15 (0%) 0
    Nervous system disorders
    Dizziness 3/56 (5.4%) 5 1/60 (1.7%) 1 2/15 (13.3%) 2
    Encephalopathy 1/56 (1.8%) 1 0/60 (0%) 0 1/15 (6.7%) 1
    Headache 3/56 (5.4%) 3 5/60 (8.3%) 6 1/15 (6.7%) 2
    Psychiatric disorders
    Confusional state 1/56 (1.8%) 1 1/60 (1.7%) 1 1/15 (6.7%) 1
    Depression 1/56 (1.8%) 1 1/60 (1.7%) 1 1/15 (6.7%) 1
    Insomnia 2/56 (3.6%) 3 3/60 (5%) 3 1/15 (6.7%) 1
    Respiratory, thoracic and mediastinal disorders
    Bronchial haemorrhage 0/56 (0%) 0 0/60 (0%) 0 1/15 (6.7%) 1
    Cough 16/56 (28.6%) 21 9/60 (15%) 9 0/15 (0%) 0
    Dyspnoea 11/56 (19.6%) 13 13/60 (21.7%) 14 2/15 (13.3%) 2
    Productive cough 1/56 (1.8%) 1 4/60 (6.7%) 4 0/15 (0%) 0
    Skin and subcutaneous tissue disorders
    Pruritus 1/56 (1.8%) 1 1/60 (1.7%) 1 1/15 (6.7%) 1
    Vascular disorders
    Hypotension 1/56 (1.8%) 1 1/60 (1.7%) 1 1/15 (6.7%) 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:
    NCT02735980
    Other Study ID Numbers:
    • 16015
    • I4D-MC-JTJH
    • 2015-005069-21
    First Posted:
    Apr 13, 2016
    Last Update Posted:
    Mar 17, 2020
    Last Verified:
    May 1, 2019