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A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02450539
Recruitment Status : Active, not recruiting
First Posted : May 21, 2015
Results First Posted : June 25, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer Stage IV
Interventions Drug: Abemaciclib
Drug: Docetaxel
Enrollment 159
Recruitment Details  
Pre-assignment Details Participants who completed were those who died due to any cause.
Arm/Group Title Abemaciclib Docetaxel
Hide Arm/Group Description 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met. 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Period Title: Overall Study
Started 106 53
Received at Least One Dose of Study Drug 106 52
Death 56 20
Completed 56 20
Not Completed 50 33
Reason Not Completed
Withdrawal by Subject             19             7
Lost to Follow-up             4             1
On study treatment/follow up             27             25
Arm/Group Title Abemaciclib Docetaxel Total
Hide Arm/Group Description 200 milligram(mg) Abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met. 75 milligram per meter squared (mg/m²) Docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met. Total of all reporting groups
Overall Number of Baseline Participants 106 53 159
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 53 participants 159 participants
63.1  (7.8) 64.5  (7.1) 63.5  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 53 participants 159 participants
Female 16 9 25
Male 90 44 134
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 53 participants 159 participants
Hispanic or Latino 5 3 8
Not Hispanic or Latino 84 48 132
Unknown or Not Reported 17 2 19
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 53 participants 159 participants
American Indian or Alaska Native 0 0 0
Asian 10 3 13
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 0 0 0
White 96 50 146
More than one race 0 0 0
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 53 participants 159 participants
Romania 18 4 22
Hungary 7 6 13
United States 4 2 6
Ukraine 13 13 26
Russia 11 2 13
Spain 8 6 14
South Korea 8 1 9
Taiwan 2 2 4
Poland 14 10 24
Italy 7 1 8
Australia 4 0 4
France 1 2 3
Germany 9 4 13
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 53 participants 159 participants
0 22 7 29
1 84 46 130
[1]
Measure Description: Participants were stratified at randomization according to the following: Eastern Cooperative Oncology Group (ECOG) PS (0 vs. 1); number of prior therapies (received only platinum-based therapy vs. platinum-based therapy plus immune checkpoint inhibitor) and time since initiation of first line therapy (<=9 months vs >9 months). The ECOG Performance Status:0 - Fully active, able to carry on all pre-disease performance without restriction,1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as time from the date of randomization to the date of investigator-determined disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, with reference the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant was not known to have died or have objective progression, PFS time will be censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.
Time Frame Baseline to Objective Progression or Death from Any Cause ( Up To 6 Months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants according to the treatment group to which they were randomized. Participants censored: Abemaciclib=19 and Docetaxel= 15.
Arm/Group Title Abemaciclib Docetaxel
Hide Arm/Group Description:
200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed 106 53
Median (95% Confidence Interval)
Unit of Measure: months
2.53
(1.68 to 2.89)
4.21
(2.79 to 5.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (<=9 months vs >9 months).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0068
Comments [Not Specified]
Method Stratified log-rank test.
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.765
Confidence Interval (2-Sided) 95%
1.165 to 2.672
Estimation Comments Stratified Cox proportional hazard model
2.Secondary Outcome
Title Pharmacokinetics (PK): Clearance of Abemaciclib
Hide Description Pharmacokinetics (PK): Clearance of Abemaciclib
Time Frame Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received abemaciclib and had evaluable PK data.
Arm/Group Title Abemaciclib
Hide Arm/Group Description:
200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle.
Overall Number of Participants Analyzed 102
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters/hour (L/h)
21.3
(36%)
3.Secondary Outcome
Title PK: Volume of Distribution of Abemaciclib
Hide Description PK: Volume of Distribution of Abemaciclib
Time Frame Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received Abemaciclib and had evaluable PK data.
Arm/Group Title Abemaciclib
Hide Arm/Group Description:
200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed 102
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters (L)
769
(51%)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from randomization to the date of death due to any cause. For each participant who is not known to have died as 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 to Date of Death from Any Cause (Approximately 11 Months)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Hide Description Overall response was defined as the percentage of randomized participants achieving a best overall response (BoR) of complete response (CR) or partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Participants with unevaluable or unknown response status are considered nonresponders. Complete response (CR) is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) is 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 Objective Progression (Up To 6 Months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Abemaciclib Docetaxel
Hide Arm/Group Description:
200 milligram(mg) Abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
75 milligram per meter squared (mg/m²) Docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed 106 53
Measure Type: Number
Unit of Measure: percentage participants
2.8 20.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value -17.9
Confidence Interval (2-Sided) 95%
-29.3 to -6.6
Estimation Comments Confidence intervals are based on the normal approximation to the binomial.
6.Secondary Outcome
Title Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)
Hide Description DCR is the percentage of randomized participants who achieved a complete response, partial response or stable disease using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Complete response (CR) is defined as the disappearance of all target and non-target lesions, and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of 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. Stable disease was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Time Frame Baseline through Measured Progressive Disease or Death Due to Any Cause (Up To 6 Months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Abemaciclib Docetaxel
Hide Arm/Group Description:
200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed 106 53
Measure Type: Number
Unit of Measure: percentage participants
50.9 64.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value -13.2
Confidence Interval (2-Sided) 95%
-29.2 to 2.8
Estimation Comments Confidence intervals are based on the normal approximation to the binomial.
7.Secondary Outcome
Title Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2
Hide Description

Worsening of ECOG performance status is the duration from randomization to ECOG PFS of >/=2. Participants without an ECOG PFS >/=2 are censored at last adequate post baseline ECOG Performance Status or randomization date (whichever is last).

The ECOG Performance Status:0 - Fully active, able to carry on all pre-disease performance without restriction,1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 - Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair, 5 - Dead

Time Frame Randomization to ECOG PFS of >/=2 (Up To 11.5 Months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants censored: Abemaciclib =93 and Docetaxel= 43.
Arm/Group Title Abemaciclib Docetaxel
Hide Arm/Group Description:
200 milligram(mg) Abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
75 milligram per meter squared (mg/m²) Docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed 106 53
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(6.58 to NA)
10.52 [1] 
(4.64 to NA)
[1]
Due to insufficient data to support the analysis and the results.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments Stratification factors are baseline ECOG performance status (0 vs 1), Number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (<=9 months vs >9 months).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7039
Comments [Not Specified]
Method Stratified Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.184
Confidence Interval (2-Sided) 95%
0.502 to 2.792
Estimation Comments Stratified Cox regression model.
8.Secondary Outcome
Title Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores
Hide Description MDASI-LC included 33 items:6 interference and 27 symptom(3 lung-cancer (LC),8 brain tumor (BT),and 3 study-specific(headache,diarrhea, and rash).Analyzed endpoints were 9 constructs:3 single-items (headache,diarrhea,and rash) and 6 composites(interference+core,LC,core+LC,BT, and core+LC worst 5 baseline).Data for all 9 constructs were collected by an 11-point numeric rating scale anchored at 0(not present or does not interfere) and 10(as bad as you can imagine or interfered completely).The measurement range was 10 (maximum score–minimum score). Between-group difference in regression-predicted change from baseline were estimated for each specified construct. MMRM models included independent variables treatment,visit, treatment*visit,and baseline score. Group-level negative change from baseline indicated group improvement.
Time Frame Baseline through End of Study (Up To 6 Months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants for cycles which at least 25% of participants in each arm have a score.MDASI-LC population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 MDASI-LC assessment after Cycle 1 (for example, a completed MDASI-LC questionnaire at Cycle 2 Day 1 or later)
Arm/Group Title Abemaciclib Docetaxel
Hide Arm/Group Description:
200 milligram(mg) Abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
75 milligram per meter squared (mg/m²) Docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed 87 43
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Headache 0.19  (0.14) 0.01  (0.18)
Diarrhea 1.01  (0.18) 0.15  (0.23)
Mean core symptom severity 0.53  (0.14) 0.00  (0.18)
Mean interference 0.50  (0.20) 0.18  (0.27)
Mean lung cancer symptom severity 0.20  (0.12) -0.19  (0.15)
Mean core plus lung cancer symptom severity 0.47  (0.13) -0.04  (0.17)
Mean brain tumor symptom severity 0.19  (0.11) 0.13  (0.15)
Mean core plus lung worst 5 symptoms severity -0.25  (0.17) -0.94  (0.22)
Rash 0.28  (0.14) 0.18  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments Headache
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments Diarrhea
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.29
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments Mean core symptom severity
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments Mean interference
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments Mean lung cancer symptom severity
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments Mean core plus lung cancer symptom severity
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments Mean brain tumor symptom severity
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments Mean core plus lung worst 5 symptoms severity
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments Rash
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score
Hide Description The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Overall self-rated health was measured with a vertical 20 cm visual analog scale (VAS) anchored at 0 (worst health) and ranged through 100 (best health). Between-group differences in regression-predicted change from baseline score were estimated for VAS scores. MMRM models included independent variables treatment, visit, treatment*visit, and baseline score. Group-level negative change from baseline indicated group improvement.
Time Frame Baseline to Measured Progressive Disease (Up To 6 Months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants for cycles which at least 25% of participants in each arm have a score.The EQ-5D-5L population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 EQ-5D-5L assessment after Cycle 1 (for example, a completed EQ-5D-5L questionnaire at Cycle 2 Day 1 or later).
Arm/Group Title Abemaciclib Docetaxel
Hide Arm/Group Description:
200 milligram(mg) Abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
75 milligram per meter squared (mg/m²) Docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed 88 42
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.49  (1.28) -2.36  (1.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments EQ VAS Overall Self-rated Health Score
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.07
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value
Hide Description There are 5 response levels on a good-to-bad continuum of 1-5 corresponding to none, slight, moderate, severe, and extreme/unable to.The EuroQol-developed crosswalk method was used to convert the EQ-5D-5L,using UK weights,health dimensions(mobility,self-care,usual activities,pain/discomfort, and anxiety/depression) into a single index value;the dimensions are not separately scored.The index is marked missing when ≥1 dimensions are missing.The index scores for the response patterns were anchored on full health to dead with negative values assigned to response patterns/health states considered worse than death.The best pattern is assigned the index value of 1.0; the worst pattern is assigned an index value of -0.594. Between-group differences in regression-predicted change from baseline score were estimated for the index .MMRM models included independent variables treatment, visit, treatment*visit, and baseline score.Group-level negative change from baseline indicated group improvement.
Time Frame Baseline to Measured Progressive Disease (Up To 6 Months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants for cycles which at least 25% of participants in each arm have a score.The EQ-5D-5L population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 EQ-5D-5L assessment after Cycle 1 (for example, a completed EQ-5D-5L questionnaire at Cycle 2 Day 1 or later).
Arm/Group Title Abemaciclib Docetaxel
Hide Arm/Group Description:
200 milligram(mg) Abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
75 milligram per meter squared (mg/m²) Docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Number of Participants Analyzed 88 42
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.05  (0.02) -0.01  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Docetaxel
Comments EQ-5D-5L Index Value
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.03
Estimation Comments [Not Specified]
Time Frame Baseline Up To 20 Months
Adverse Event Reporting Description All randomized participants who received at least one dose of study drug.
 
Arm/Group Title Abemaciclib Docetaxel
Hide Arm/Group Description 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met. 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
All-Cause Mortality
Abemaciclib Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   56/106 (52.83%)      19/52 (36.54%)    
Show Serious Adverse Events Hide Serious Adverse Events
Abemaciclib Docetaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/106 (27.36%)      17/52 (32.69%)    
Blood and lymphatic system disorders     
Anaemia  1  1/106 (0.94%)  2 0/52 (0.00%)  0
Febrile neutropenia  1  0/106 (0.00%)  0 3/52 (5.77%)  3
Leukopenia  1  0/106 (0.00%)  0 2/52 (3.85%)  2
Neutropenia  1  1/106 (0.94%)  1 4/52 (7.69%)  4
Pancytopenia  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Cardiac disorders     
Cardiovascular insufficiency  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Diarrhoea  1  2/106 (1.89%)  2 1/52 (1.92%)  1
Gastric haemorrhage  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Nausea  1  1/106 (0.94%)  1 1/52 (1.92%)  1
Oesophageal fistula  1  1/106 (0.94%)  1 0/52 (0.00%)  0
General disorders     
General physical health deterioration  1  0/106 (0.00%)  0 1/52 (1.92%)  1
Pyrexia  1  1/106 (0.94%)  1 1/52 (1.92%)  1
Immune system disorders     
Anaphylactic reaction  1  0/106 (0.00%)  0 1/52 (1.92%)  1
Infections and infestations     
Bronchitis  1  0/106 (0.00%)  0 1/52 (1.92%)  1
Lung infection  1  6/106 (5.66%)  6 3/52 (5.77%)  3
Myelitis  1  0/106 (0.00%)  0 1/52 (1.92%)  1
Pleural infection  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Salmonella bacteraemia  1  0/106 (0.00%)  0 1/52 (1.92%)  1
Upper respiratory tract infection  1  1/106 (0.94%)  1 1/52 (1.92%)  1
Wound infection  1  0/106 (0.00%)  0 1/52 (1.92%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Investigations     
Blood creatinine increased  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Eastern cooperative oncology group performance status worsened  1  1/106 (0.94%)  1 0/52 (0.00%)  0
International normalised ratio increased  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Hypokalaemia  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Hyponatraemia  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour pain  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  1  0/106 (0.00%)  0 1/52 (1.92%)  1
Dizziness  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Syncope  1  0/106 (0.00%)  0 1/52 (1.92%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Renal failure  1  2/106 (1.89%)  2 0/52 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchial fistula  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Dyspnoea  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Hypoxia  1  0/106 (0.00%)  0 1/52 (1.92%)  1
Laryngeal haemorrhage  1  2/106 (1.89%)  2 1/52 (1.92%)  1
Pleural effusion  1  1/106 (0.94%)  1 1/52 (1.92%)  1
Pneumonitis  1  3/106 (2.83%)  3 1/52 (1.92%)  1
Respiratory failure  1  1/106 (0.94%)  1 0/52 (0.00%)  0
Vascular disorders     
Embolism  1  3/106 (2.83%)  3 0/52 (0.00%)  0
Hypotension  1  1/106 (0.94%)  1 0/52 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abemaciclib Docetaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   94/106 (88.68%)      43/52 (82.69%)    
Blood and lymphatic system disorders     
Anaemia  1  41/106 (38.68%)  47 12/52 (23.08%)  18
Leukopenia  1  10/106 (9.43%)  10 14/52 (26.92%)  47
Neutropenia  1  18/106 (16.98%)  20 26/52 (50.00%)  74
Thrombocytopenia  1  27/106 (25.47%)  30 2/52 (3.85%)  2
Gastrointestinal disorders     
Abdominal pain  1  8/106 (7.55%)  10 3/52 (5.77%)  3
Diarrhoea  1  40/106 (37.74%)  64 5/52 (9.62%)  5
Nausea  1  33/106 (31.13%)  35 7/52 (13.46%)  10
Vomiting  1  9/106 (8.49%)  11 3/52 (5.77%)  3
General disorders     
Fatigue  1  30/106 (28.30%)  34 7/52 (13.46%)  10
Non-cardiac chest pain  1  8/106 (7.55%)  9 2/52 (3.85%)  2
Pain  1  1/106 (0.94%)  1 3/52 (5.77%)  3
Pyrexia  1  5/106 (4.72%)  5 4/52 (7.69%)  4
Investigations     
Blood alkaline phosphatase increased  1  1/106 (0.94%)  1 3/52 (5.77%)  3
Blood creatinine increased  1  13/106 (12.26%)  17 1/52 (1.92%)  6
Weight decreased  1  12/106 (11.32%)  13 5/52 (9.62%)  5
Metabolism and nutrition disorders     
Decreased appetite  1  17/106 (16.04%)  19 7/52 (13.46%)  7
Hypokalaemia  1  8/106 (7.55%)  10 1/52 (1.92%)  2
Hyponatraemia  1  7/106 (6.60%)  9 1/52 (1.92%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  2/106 (1.89%)  2 3/52 (5.77%)  3
Muscular weakness  1  10/106 (9.43%)  12 7/52 (13.46%)  8
Nervous system disorders     
Dizziness  1  8/106 (7.55%)  10 3/52 (5.77%)  3
Headache  1  7/106 (6.60%)  7 2/52 (3.85%)  2
Neuropathy  1  3/106 (2.83%)  3 7/52 (13.46%)  9
Respiratory, thoracic and mediastinal disorders     
Cough  1  11/106 (10.38%)  11 2/52 (3.85%)  2
Dyspnoea  1  19/106 (17.92%)  20 6/52 (11.54%)  6
Laryngeal haemorrhage  1  8/106 (7.55%)  8 1/52 (1.92%)  1
Productive cough  1  6/106 (5.66%)  7 2/52 (3.85%)  2
Skin and subcutaneous tissue disorders     
Alopecia  1  1/106 (0.94%)  1 7/52 (13.46%)  8
Vascular disorders     
Hypotension  1  8/106 (7.55%)  8 0/52 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02450539     History of Changes
Other Study ID Numbers: 15806
I3Y-MC-JPBX ( Other Identifier: Eli Lilly and Company )
2014-004832-20 ( EudraCT Number )
First Submitted: May 19, 2015
First Posted: May 21, 2015
Results First Submitted: March 30, 2018
Results First Posted: June 25, 2018
Last Update Posted: October 31, 2018