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| ID | Type | Description | Link |
|---|---|---|---|
| I4D-MC-JTJH | Other Identifier | Eli Lilly and Company | |
| 2015-005069-21 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prexasertib (Platinum Sensitive Disease) | Experimental | 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). |
|
| Prexasertib (Platinum Resistant Disease) | Experimental | 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). |
|
| Prexasertib Exploratory Addendum (Platinum Sensitive Disease) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prexasertib | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | 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 | Baseline to 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2 | Pharmacokinetics(PK): Maximum Concentration of Prexasertib. The same dose was administered to Cohort 1 and Cohort 2 and were combined for analysis. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States | ||
| Yale University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34665631 | Derived | Jin T, Xu L, Wang P, Hu X, Zhang R, Wu Z, Du W, Kan W, Li K, Wang C, Zhou Y, Li J, Liu T. Discovery and Development of a Potent, Selective, and Orally Bioavailable CHK1 Inhibitor Candidate: 5-((4-((3-Amino-3-methylbutyl)amino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)picolinonitrile. J Med Chem. 2021 Oct 28;64(20):15069-15090. doi: 10.1021/acs.jmedchem.1c00994. Epub 2021 Oct 19. |
| Label | URL |
|---|---|
| Click here for more information about this study: A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 105 mg/m^2 Prexasertib (Platinum Sensitive Disease) | Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle |
| FG001 | 105 mg/m^2 Prexasertib (Platinum Resistant Disease) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2016 | Dec 6, 2019 |
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| Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda) | Pharmacokinetics(PK): Maximum Concentration 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 | 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 |
| Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) | 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. | Baseline through Disease Progression or Death from Any Cause to 28 months |
| Progression-Free Survival (PFS) | 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. | Baseline to Disease Progression or Death (up to 9 months) |
| Duration of Response (DoR) | 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. | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 months |
| Overall Survival (OS) | 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. | Baseline up to 28 months |
| Change From Baseline in Lung Cancer Symptom Scale Score (LCSS) | 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). | Baseline up to 9 months |
| Change From Baseline on the Average Symptom Burden Index (ASBI) | 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). | Baseline up to 9 months |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33908 | United States |
| Florida Cancer Specialists and Research Institute | St. Petersburg | Florida | 33705 | United States |
| Massachusetts General Hospital | Danvers | Massachusetts | 01923 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0001 | United States |
| Chattanooga Oncology Hematology Associates | Chattanooga | Tennessee | 37404 | United States |
| Sarah Cannon Cancer Center | Nashville | Tennessee | 37203 | United States |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-6307 | United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| 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. | Besançon | 25030 | France |
| 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 | 59037 | France |
| "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 | 34070 | France |
| 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 | 57070 | France |
| 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 | 06120 | Germany |
| 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 | 11527 | Greece |
| 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 | 71110 | Greece |
| 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. | Pátrai | 26504 | Greece |
| 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 | 1066 CX | Netherlands |
| 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 | 4818 CK | Netherlands |
| 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 | 8025 AB | Netherlands |
| 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 | 06351 | South Korea |
| 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 | 120-792 | South Korea |
| 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 | 08035 | Spain |
| 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 | 28034 | Spain |
| 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 | 50009 | Spain |
| 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 | 07059 | Turkey (Türkiye) |
| 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 (Türkiye) |
| 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 | 34098 | Turkey (Türkiye) |
| 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 | 35100 | Turkey (Türkiye) |
| 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 | 38039 | Turkey (Türkiye) |
| 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 | 49102 | Ukraine |
| 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 | 61070 | Ukraine |
| 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 | 40005 | Ukraine |
| 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 | OX3 7LJ | United Kingdom |
| 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 | LE1 5WN | United Kingdom |
| 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 | S10 2SJ | United Kingdom |
IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle
| FG002 | 40 mg/m2 Prexasertib Exploratory Addendum | 40 mg/m2 IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Prexasertib (Platinum Sensitive Disease) | Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle |
| BG001 | Prexasertib (Platinum Resistant Disease) | IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle |
| BG002 | Prexasertib Exploratory Addendum (Platinum Sensitive Disease) | IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | N is number of participants with non-missing data. | Count of Participants | Participants | No |
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| Race (NIH/OMB) | N is number of participants with non-missing data. | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | 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 | All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to 10 months |
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| Secondary | Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2 | Pharmacokinetics(PK): Maximum Concentration of Prexasertib. The same dose was administered to Cohort 1 and Cohort 2 and were combined for analysis. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | 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 |
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| Secondary | Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda) | Pharmacokinetics(PK): Maximum Concentration of Prexasertib | Al randomized participants with at least 1 dose of study drug, received 40 mg/m^2 and had evaluable PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | 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 |
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| Secondary | Pharmacokinetics: Area Under the Concentration Curve of Prexasertib | Pharmacokinetics: Area Under the Concentration Curve of Prexasertib | All participants in Part A1 that received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg*h/mL | 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 |
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| Secondary | Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) | 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. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through Disease Progression or Death from Any Cause to 28 months |
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| Secondary | Progression-Free Survival (PFS) | 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. | All randomized participants. 4 participants were censored from Prexasertib Cohort 1 and 1 participant from Prexasertib Cohort 3. | Posted | Median | 95% Confidence Interval | months | Baseline to Disease Progression or Death (up to 9 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | 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. | 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. | Posted | Number | days | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | 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. | All randomized participants. 8 participants were censored from Cohort 1, 5 participants were censored from Cohort 2 and 4 participants censored from Cohort 3. | Posted | Median | 95% Confidence Interval | months | Baseline up to 28 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Lung Cancer Symptom Scale Score (LCSS) | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline up to 9 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline on the Average Symptom Burden Index (ASBI) | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline up to 9 months |
|
|
up to 28 months
All randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 105 mg/m^2 Prexasertib (Platinum Sensitive Disease) | Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle | 10 | 56 | 21 | 56 | 56 | 56 |
| EG001 | 105 mg/m^2 Prexasertib (Platinum Resistant Disease) | IV prexasertib (LY2606368) administered on day 1 of every 14 day cycle | 7 | 60 | 16 | 60 | 59 | 60 |
| EG002 | 40 mg/m2 Prexasertib Exploratory Addendum | IV 40 mg/m2 prexasertib (LY2606368) IV administered on Days 1, 2 and 3 of a 14-day cycle | 11 | 15 | 6 | 15 | 15 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Electrocardiogram qt prolonged | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cauda equina syndrome | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Eye haematoma | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Electrocardiogram qt prolonged | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2016 | Dec 6, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000608121 | prexasertib |
Not provided
Not provided
Not provided
|
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| Netherlands |
|
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| South Korea |
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| Turkey |
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| United States |
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| Ukraine |
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| United Kingdom |
|
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| France |
|
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| Germany |
|
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| Spain |
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| Participants |
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|
IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle |
|
|
| OG002 | Prexasertib Exploratory Addendum (Platinum Sensitive Disease) | IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle |
|
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| Units | Counts |
|---|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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