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A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer (JUNIPER)

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ClinicalTrials.gov Identifier: NCT02152631
Recruitment Status : Active, not recruiting
First Posted : June 2, 2014
Results First Posted : December 12, 2018
Last Update Posted : October 29, 2019
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
Interventions Drug: Abemaciclib
Drug: Erlotinib
Enrollment 453
Recruitment Details  
Pre-assignment Details Completers are defined as those participants who had progressive disease, death due to any cause or alive and on study at the end of study, but off treatment.
Arm/Group Title Abemaciclib Erlotinib
Hide Arm/Group Description 200 milligrams (mg) abemaciclib administered, orally, every 12 hours plus best supportive care (BSC) on Days 1 to 28 (28 day cycles). 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Period Title: Overall Study
Started 270 183
Received at Least One Dose of Study Drug 265 175
Off Treatment 246 172
Death Due to Any Cause 30 20
Progressive Disease 174 137
Completed 204 157
Not Completed 66 26
Reason Not Completed
Adverse Event             32             4
Withdrawal by Subject             13             16
Noncompliance with study drug             1             0
Physician Decision             1             2
Lost to Follow-up             0             1
On Treatment             19             3
Arm/Group Title Abemaciclib Erlotinib Total
Hide Arm/Group Description 200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles). 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles). Total of all reporting groups
Overall Number of Baseline Participants 270 183 453
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 270 participants 183 participants 453 participants
62.3  (8.9) 62.9  (8.4) 62.5  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 183 participants 453 participants
Female 107 74 181
Male 163 109 272
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 183 participants 453 participants
Hispanic or Latino 13 12 25
Not Hispanic or Latino 197 132 329
Unknown or Not Reported 60 39 99
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 183 participants 453 participants
American Indian or Alaska Native 0 1 1
Asian 56 41 97
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 1 2 3
White 165 106 271
More than one race 3 1 4
Unknown or Not Reported 45 32 77
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 183 participants 453 participants
Argentina 1 2 3
Romania 7 7 14
United States 44 30 74
Japan 22 17 39
Ukraine 6 5 11
Russia 8 4 12
Spain 26 13 39
Greece 1 6 7
Canada 4 4 8
Austria 0 2 2
South Korea 13 13 26
Turkey 21 8 29
China 7 4 11
Taiwan 12 7 19
Brazil 7 5 12
Poland 6 2 8
Italy 5 12 17
Israel 5 1 6
France 35 32 67
Germany 30 14 44
1.Primary Outcome
Title Overall Survival (OS)
Hide 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 From Randomization Date to Date of Death from Any Cause (Up to 32 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. 81 participants were censored in the Abemaciclib arm and 56 participants were censored in the Erlotinib arm.
Arm/Group Title Abemaciclib Erlotinib
Hide Arm/Group Description:
200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).
150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Number of Participants Analyzed 270 183
Median (95% Confidence Interval)
Unit of Measure: months
7.4
(6.5 to 8.8)
7.8
(6.4 to 9.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Erlotinib
Comments The stratification factors used in the analysis were: number of prior chemotherapy regimens (1 versus 2), Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) (0 versus 1), gender (male versus female), and kirsten rat sarcoma (KRAS) mutation (GLY12CYS [G12C] vs. all others)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.771
Comments [Not Specified]
Method Stratified Log-Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.968
Confidence Interval (2-Sided) 95%
0.768 to 1.219
Estimation Comments Hazard Ratio (HR) was estimated based on Stratified Cox proportional hazard model.
2.Secondary Outcome
Title Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Hide 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 From Randomization Date to Objective Progression (Up to 32 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Abemaciclib Erlotinib
Hide Arm/Group Description:
200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).
150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Number of Participants Analyzed 270 183
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.9
(5.5 to 12.3)
2.7
(0.4 to 5.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Erlotinib
Comments Stratified by number of prior chemotherapy regimens (1 versus 2), ECOG PS (0 versus 1), gender (male versus female), and KRAS mutation (GLY12CYS [G12C] vs. all others)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide 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 From Randomization Date until Disease Progression or Death from Any Cause (Up to 32 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. 36 participants were censored in the abemaciclib arm and 24 were censored in the erlotinib arm.
Arm/Group Title Abemaciclib Erlotinib
Hide Arm/Group Description:
200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).
150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Number of Participants Analyzed 270 183
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: months
3.6
(2.8 to 3.8)
1.9
(1.9 to 2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Erlotinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.000001
Comments [Not Specified]
Method Stratified Log-Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.583
Confidence Interval (2-Sided) 95%
0.470 to 0.723
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score
Hide Description The MDASI-LC included 22 items + 3 additional trial-specific items, resulting in 6 collected and reported single-construct scores including core symptoms (13-item), interference (6-item), lung cancer (3-item), and trial-specific single outcomes for headache, diarrhea, and rash. A 2-construct composite core + lung cancer symptom (16-item) score was calculated. Data for all 7 scores 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). Mixed Model Repeated Measure (MMRM) regression with covariates for treatment, visit, treatment*visit, and baseline score predicted between-group Least Squares (LS) mean differences from baseline. Group-level negative change from baseline indicated group improvement.
Time Frame From Randomization Date through End of Study (Up to 32 Months)
Hide 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 result.
Arm/Group Title Abemaciclib Erlotinib
Hide Arm/Group Description:
200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).
150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Number of Participants Analyzed 270 183
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Headache 0.20  (0.11) 0.27  (0.15)
Diarrhea 1.91  (0.17) 1.32  (0.23)
Rash 0.65  (0.17) 3.05  (0.22)
Mean Core Symptom Severity 0.49  (0.10) 0.73  (0.13)
Mean Interference 0.70  (0.14) 0.85  (0.18)
Mean Lung Cancer Symptom Severity 0.16  (0.09) 0.23  (0.12)
Mean Core Plus Lung Cancer Symptom Severity 0.44  (0.09) 0.65  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Erlotinib
Comments Headache
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.698
Comments [Not Specified]
Method Mixed Models Analysis
Comments Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.
Method of Estimation Estimation Parameter LS Mean Change Difference
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.44 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Erlotinib
Comments Diarrhea
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method Mixed Models Analysis
Comments Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.
Method of Estimation Estimation Parameter LS Mean Change Difference
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.03 to 1.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Erlotinib
Comments Rash
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.
Method of Estimation Estimation Parameter LS Mean Change Difference
Estimated Value -2.40
Confidence Interval (2-Sided) 95%
-2.94 to -1.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Erlotinib
Comments Mean Core Symptom Severity
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
Method Mixed Models Analysis
Comments Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.
Method of Estimation Estimation Parameter LS Mean Change Difference
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.56 to 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Erlotinib
Comments Mean Interference
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.514
Comments [Not Specified]
Method Mixed Models Analysis
Comments Analyzed by Type 3 sums of square, model covariates included Treatment + Visit + Treatment*Visit + Baseline.
Method of Estimation Estimation Parameter LS Mean Change Difference
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.59 to 0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Erlotinib
Comments Mean Lung Cancer
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.646
Comments [Not Specified]
Method Mixed Models Analysis
Comments Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.
Method of Estimation Estimation Parameter LS Mean Change Difference
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.37 to 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Erlotinib
Comments Mean Core Plus Lung Cancer
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.188
Comments [Not Specified]
Method Mixed Models Analysis
Comments Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.
Method of Estimation Estimation Parameter LS Mean Change Difference
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.51 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval at Steady State
Hide Description PK is determined by the area under the plasma concentration versus time curve during 1 dosing interval at steady state
Time Frame Day 1 of Cycle 1 through Cycle 3 (28 Day Cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received Abemaciclib and had evaluable PK data.
Arm/Group Title Abemaciclib
Hide Arm/Group Description:
200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Number of Participants Analyzed 265
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*nanogram/milliliter (h*ng/mL)
3350
(52%)
6.Secondary Outcome
Title Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Score
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 United Kingdom (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. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.
Time Frame From Randomization Date through End of Study (Up to 32 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and with a baseline and at least 1 post-baseline result.
Arm/Group Title Abemaciclib Erlotinib
Hide Arm/Group Description:
200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).
150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Number of Participants Analyzed 270 183
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.08  (0.01) -0.08  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abemaciclib, Erlotinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.951
Comments [Not Specified]
Method Mixed Models Analysis
Comments Analyzed By Type 3 sums of squares, Change from Baseline = Treatment + Visit + Treatment*Visit + Baseline.
Method of Estimation Estimation Parameter LS Mean Change Difference
Estimated Value -0.00
Confidence Interval (2-Sided) 95%
-0.05 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Resource Utilization: Percentage of Participants Who Are Hospitalized
Hide Description Resource utilization is the percentage of participants who was hospitalized.
Time Frame From Randomization Date through End of Study (Up to 32 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Abemaciclib Erlotinib
Hide Arm/Group Description:
200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles).
150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Overall Number of Participants Analyzed 265 175
Measure Type: Number
Unit of Measure: percentage of participants
40.4 22.9
Time Frame From Baseline to End of Study (Up to 47 Months)
Adverse Event Reporting Description All randomized participants who received at least one dose of study drug.
 
Arm/Group Title Abemaciclib Erlotinib
Hide Arm/Group Description 200 mg abemaciclib administered, orally, every 12 hours plus BSC on Days 1 to 28 (28 day cycles). 150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
All-Cause Mortality
Abemaciclib Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   186/265 (70.19%)      123/175 (70.29%)    
Show Serious Adverse Events Hide Serious Adverse Events
Abemaciclib Erlotinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   112/265 (42.26%)      43/175 (24.57%)    
Blood and lymphatic system disorders     
Anaemia  1  3/265 (1.13%)  4 3/175 (1.71%)  3
Febrile bone marrow aplasia  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Febrile neutropenia  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Neutropenia  1  2/265 (0.75%)  2 0/175 (0.00%)  0
Pancytopenia  1  1/265 (0.38%)  2 0/175 (0.00%)  0
Cardiac disorders     
Atrial tachycardia  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Cardiac arrest  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Cardiac failure  1  1/265 (0.38%)  1 1/175 (0.57%)  1
Cardiac tamponade  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Cardiopulmonary failure  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Pericardial effusion  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Supraventricular tachycardia  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Congenital, familial and genetic disorders     
Tracheo-oesophageal fistula  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Ear and labyrinth disorders     
Vertigo positional  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Endocrine disorders     
Adrenal insufficiency  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Diarrhoea  1  10/265 (3.77%)  10 0/175 (0.00%)  0
Gastric haemorrhage  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Nausea  1  7/265 (2.64%)  7 0/175 (0.00%)  0
Pancreatitis  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Vomiting  1  5/265 (1.89%)  6 2/175 (1.14%)  2
General disorders     
Asthenia  1  2/265 (0.75%)  4 0/175 (0.00%)  0
Death  1  2/265 (0.75%)  2 0/175 (0.00%)  0
Fatigue  1  1/265 (0.38%)  1 1/175 (0.57%)  1
General physical health deterioration  1  3/265 (1.13%)  3 1/175 (0.57%)  1
Malaise  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Non-cardiac chest pain  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Oedema  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Pyrexia  1  1/265 (0.38%)  1 1/175 (0.57%)  1
Hepatobiliary disorders     
Drug-induced liver injury  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Hepatic failure  1  1/265 (0.38%)  3 0/175 (0.00%)  0
Infections and infestations     
Bronchitis  1  2/265 (0.75%)  2 0/175 (0.00%)  0
Cellulitis  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Clostridial sepsis  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Clostridium difficile colitis  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Empyema  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Enterocolitis infectious  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Lung infection  1  3/265 (1.13%)  4 1/175 (0.57%)  1
Oesophageal candidiasis  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Oral candidiasis  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Pneumocystis jirovecii pneumonia  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Pneumonia  1  13/265 (4.91%)  15 6/175 (3.43%)  9
Pneumonia bacterial  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Pneumonia fungal  1  1/265 (0.38%)  2 0/175 (0.00%)  0
Pyelonephritis acute  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Respiratory tract infection  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Sepsis  1  2/265 (0.75%)  2 2/175 (1.14%)  2
Sepsis pasteurella  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Septic shock  1  2/265 (0.75%)  2 1/175 (0.57%)  2
Skin infection  1  1/265 (0.38%)  1 1/175 (0.57%)  1
Urinary tract infection  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Chemical poisoning  1  1/265 (0.38%)  2 0/175 (0.00%)  0
Fall  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Hip fracture  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Radiation pneumonitis  1  1/265 (0.38%)  1 1/175 (0.57%)  1
Rib fracture  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Spinal compression fracture  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Spinal fracture  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Investigations     
Alanine aminotransferase increased  1  1/265 (0.38%)  2 0/175 (0.00%)  0
Aspartate aminotransferase increased  1  2/265 (0.75%)  6 0/175 (0.00%)  0
Blood bilirubin increased  1  1/265 (0.38%)  2 0/175 (0.00%)  0
Blood creatinine increased  1  2/265 (0.75%)  6 0/175 (0.00%)  0
International normalised ratio increased  1  1/265 (0.38%)  1 1/175 (0.57%)  1
Platelet count decreased  1  3/265 (1.13%)  5 0/175 (0.00%)  0
Weight decreased  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  3/265 (1.13%)  3 1/175 (0.57%)  1
Dehydration  1  10/265 (3.77%)  12 1/175 (0.57%)  1
Hypercalcaemia  1  1/265 (0.38%)  1 1/175 (0.57%)  1
Hyperglycaemia  1  1/265 (0.38%)  2 2/175 (1.14%)  4
Hyperkalaemia  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Hypoalbuminaemia  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Hypocalcaemia  1  1/265 (0.38%)  2 0/175 (0.00%)  0
Hypokalaemia  1  2/265 (0.75%)  2 0/175 (0.00%)  0
Hyponatraemia  1  3/265 (1.13%)  3 1/175 (0.57%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  0/265 (0.00%)  0 2/175 (1.14%)  2
Muscle spasms  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Osteoarthritis  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Osteoporosis  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Metastases to central nervous system  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Tumour pain  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Nervous system disorders     
Aphasia  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Cerebral infarction  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Cerebral ischaemia  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Depressed level of consciousness  1  2/265 (0.75%)  2 0/175 (0.00%)  0
Encephalopathy  1  2/265 (0.75%)  3 0/175 (0.00%)  0
Ischaemic stroke  1  2/265 (0.75%)  3 0/175 (0.00%)  0
Neuralgia  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Paraesthesia  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Peripheral sensorimotor neuropathy  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Spinal cord compression  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Syncope  1  1/265 (0.38%)  1 1/175 (0.57%)  1
Psychiatric disorders     
Confusional state  1  3/265 (1.13%)  4 0/175 (0.00%)  0
Suicide attempt  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  10/265 (3.77%)  15 1/175 (0.57%)  1
Anuria  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Renal failure  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Renal impairment  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Acute respiratory failure  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Dyspnoea  1  8/265 (3.02%)  8 7/175 (4.00%)  11
Haemoptysis  1  0/265 (0.00%)  0 1/175 (0.57%)  5
Hypoxia  1  1/265 (0.38%)  1 1/175 (0.57%)  3
Interstitial lung disease  1  1/265 (0.38%)  2 0/175 (0.00%)  0
Laryngeal obstruction  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Laryngeal oedema  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Lung infiltration  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Pleural effusion  1  3/265 (1.13%)  3 2/175 (1.14%)  4
Pleuritic pain  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Pneumonitis  1  3/265 (1.13%)  6 3/175 (1.71%)  3
Pneumothorax  1  1/265 (0.38%)  1 2/175 (1.14%)  2
Pulmonary cavitation  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Pulmonary embolism  1  4/265 (1.51%)  5 1/175 (0.57%)  1
Pulmonary haemorrhage  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Respiratory failure  1  4/265 (1.51%)  6 1/175 (0.57%)  2
Respiratory tract congestion  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Skin and subcutaneous tissue disorders     
Subcutaneous emphysema  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Urticaria  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Vascular disorders     
Deep vein thrombosis  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Embolism  1  0/265 (0.00%)  0 1/175 (0.57%)  1
Hypotension  1  2/265 (0.75%)  2 0/175 (0.00%)  0
Peripheral arterial occlusive disease  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Shock haemorrhagic  1  1/265 (0.38%)  1 0/175 (0.00%)  0
Superior vena cava syndrome  1  1/265 (0.38%)  1 1/175 (0.57%)  1
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 Erlotinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   247/265 (93.21%)      161/175 (92.00%)    
Blood and lymphatic system disorders     
Anaemia  1  87/265 (32.83%)  163 23/175 (13.14%)  30
Neutropenia  1  19/265 (7.17%)  44 1/175 (0.57%)  1
Thrombocytopenia  1  17/265 (6.42%)  25 1/175 (0.57%)  3
Gastrointestinal disorders     
Abdominal pain  1  30/265 (11.32%)  34 8/175 (4.57%)  8
Constipation  1  29/265 (10.94%)  32 15/175 (8.57%)  17
Diarrhoea  1  169/265 (63.77%)  331 69/175 (39.43%)  100
Nausea  1  94/265 (35.47%)  127 30/175 (17.14%)  33
Stomatitis  1  14/265 (5.28%)  14 10/175 (5.71%)  10
Vomiting  1  61/265 (23.02%)  89 15/175 (8.57%)  15
General disorders     
Asthenia  1  44/265 (16.60%)  82 13/175 (7.43%)  16
Fatigue  1  73/265 (27.55%)  132 29/175 (16.57%)  38
Non-cardiac chest pain  1  15/265 (5.66%)  17 7/175 (4.00%)  7
Pyrexia  1  33/265 (12.45%)  40 11/175 (6.29%)  11
Investigations     
Aspartate aminotransferase increased  1  15/265 (5.66%)  26 7/175 (4.00%)  8
Blood creatinine increased  1  45/265 (16.98%)  81 2/175 (1.14%)  2
Neutrophil count decreased  1  40/265 (15.09%)  130 2/175 (1.14%)  4
Platelet count decreased  1  42/265 (15.85%)  103 5/175 (2.86%)  7
Weight decreased  1  42/265 (15.85%)  54 16/175 (9.14%)  22
White blood cell count decreased  1  28/265 (10.57%)  83 4/175 (2.29%)  6
Metabolism and nutrition disorders     
Decreased appetite  1  95/265 (35.85%)  133 42/175 (24.00%)  52
Dehydration  1  15/265 (5.66%)  18 1/175 (0.57%)  1
Hypoalbuminaemia  1  18/265 (6.79%)  24 8/175 (4.57%)  15
Hypokalaemia  1  22/265 (8.30%)  31 9/175 (5.14%)  10
Hyponatraemia  1  17/265 (6.42%)  37 6/175 (3.43%)  11
Musculoskeletal and connective tissue disorders     
Back pain  1  15/265 (5.66%)  15 11/175 (6.29%)  15
Nervous system disorders     
Dizziness  1  18/265 (6.79%)  19 5/175 (2.86%)  6
Headache  1  24/265 (9.06%)  29 11/175 (6.29%)  12
Psychiatric disorders     
Insomnia  1  15/265 (5.66%)  16 7/175 (4.00%)  7
Respiratory, thoracic and mediastinal disorders     
Cough  1  38/265 (14.34%)  45 21/175 (12.00%)  22
Dyspnoea  1  53/265 (20.00%)  74 22/175 (12.57%)  26
Productive cough  1  16/265 (6.04%)  17 4/175 (2.29%)  4
Skin and subcutaneous tissue disorders     
Dermatitis acneiform  1  1/265 (0.38%)  4 46/175 (26.29%)  68
Dry skin  1  14/265 (5.28%)  14 26/175 (14.86%)  35
Pruritus  1  17/265 (6.42%)  22 18/175 (10.29%)  27
Rash  1  11/265 (4.15%)  14 42/175 (24.00%)  68
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
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Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02152631     History of Changes
Other Study ID Numbers: 15296
I3Y-MC-JPBK ( Other Identifier: Eli Lilly and Company )
2013-004662-33 ( EudraCT Number )
First Submitted: May 23, 2014
First Posted: June 2, 2014
Results First Submitted: August 23, 2018
Results First Posted: December 12, 2018
Last Update Posted: October 29, 2019