Trial Outcomes & Findings for Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer (NCT NCT01107444)
NCT ID: NCT01107444
Last Updated: 2019-09-11
Results Overview
The tumor size was defined as the sum of the longest diameters for the target lesions. The sum of lesion diameters was calculated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. The log ratio of tumor size at the end of Cycle 2 to tumor size at baseline was calculated for each participant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
Baseline, End of Cycle 2 (1 cycle = 21 days)
Results posted on
2019-09-11
Participant Flow
Participant milestones
| Measure |
LY2181308 + Docetaxel
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
60
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
114
|
48
|
|
Overall Study
COMPLETED
|
112
|
47
|
|
Overall Study
NOT COMPLETED
|
8
|
13
|
Reasons for withdrawal
| Measure |
LY2181308 + Docetaxel
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
12
|
|
Overall Study
Protocol Entry Criteria Not Met
|
0
|
1
|
Baseline Characteristics
Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
LY2181308 + Docetaxel
n=114 Participants
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=48 Participants
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.19 years
STANDARD_DEVIATION 9.74 • n=93 Participants
|
64.10 years
STANDARD_DEVIATION 8.37 • n=4 Participants
|
62.05 years
STANDARD_DEVIATION 9.42 • n=27 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
110 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
155 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
20 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
17 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
15 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
24 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
0
|
37 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
1
|
77 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
|
Initial pathological diagnosis
Adenocarcinoma, poorly differentiated, lung
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Initial pathological diagnosis
Adenocarcinoma, bronchioalveolar
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Initial pathological diagnosis
Adenocarcinoma, lung
|
58 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
|
Initial pathological diagnosis
Neuroendocrine carcinoma (CA)
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Initial pathological diagnosis
Large cell lung CA
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Initial pathological diagnosis
Non-small cell lung carcinoma (NSCLC)
|
14 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Initial pathological diagnosis
NSCLC, poorly differentiated
|
9 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Initial pathological diagnosis
Squamous cell lung CA
|
25 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Initial pathological diagnosis
NSCLC, not otherwise specified (NOS)
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Disease stage at study entry
Stage IIIB
|
10 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Disease stage at study entry
Stage IV
|
104 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
146 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, End of Cycle 2 (1 cycle = 21 days)Population: Participants who received at least 1 dose of study drug and had tumor size measurements (according to the pre-specified inclusion criteria) at baseline and at the end of Cycle 2.
The tumor size was defined as the sum of the longest diameters for the target lesions. The sum of lesion diameters was calculated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. The log ratio of tumor size at the end of Cycle 2 to tumor size at baseline was calculated for each participant.
Outcome measures
| Measure |
LY2181308 + Docetaxel
n=82 Participants
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=42 Participants
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Change From Baseline in Tumor Size to the End of Cycle 2
|
1.06 Log Ratio of Tumor Size
Standard Deviation 0.2
|
1.01 Log Ratio of Tumor Size
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: Randomization through long-term follow up (up to 21.6 months)Population: Participants who received at least 1 dose of study drug.
Safety analyses included listings and/or summaries of the following: 1. CTCAE for laboratory and non-laboratory parameters possibly related to study drug; 2. CTCAE Grades 3 and 4 for laboratory and non-laboratory parameters possibly related to study drug (Grade 3 - severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care. Grade 4 - life-threatening consequences; urgent intervention indicated); 3. Dose adjustments due to adverse events (AEs).
Outcome measures
| Measure |
LY2181308 + Docetaxel
n=114 Participants
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=48 Participants
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Number of Participants With Characterization of Toxicities as Defined by Common Terminology Criteria for Adverse Events (CTCAE) Coding
Participants with >= 1 CTCAE
|
98 Participants
|
42 Participants
|
|
Number of Participants With Characterization of Toxicities as Defined by Common Terminology Criteria for Adverse Events (CTCAE) Coding
Participants with >= 1 CTCAE Grade 3 or Grade 4
|
76 Participants
|
34 Participants
|
|
Number of Participants With Characterization of Toxicities as Defined by Common Terminology Criteria for Adverse Events (CTCAE) Coding
Participants with Docetaxel Dose Changes Due to AE
|
24 Participants
|
11 Participants
|
|
Number of Participants With Characterization of Toxicities as Defined by Common Terminology Criteria for Adverse Events (CTCAE) Coding
Participants with LY2181308 Dose Changes Due to AE
|
8 Participants
|
NA Participants
Participants in this arm of the study did not receive LY2181308.
|
SECONDARY outcome
Timeframe: Randomization to the first date of progressive disease or death from any cause (up to 12.88 months)Population: Participants who received at least 1 dose of study drug. A total of 10 participants were censored in the Docetaxel arm; 18 participants were censored in the LY2181308 + Docetaxel arm.
Progression Free Survival (PFS) was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. PFS time was censored at the date of the last assessment visit for participants who were still alive and who did not have documented progressive disease as of the data cut-off date.
Outcome measures
| Measure |
LY2181308 + Docetaxel
n=114 Participants
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=48 Participants
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
2.83 Months
Interval 1.84 to 3.65
|
3.35 Months
Interval 2.69 to 4.57
|
SECONDARY outcome
Timeframe: Docetaxel: Cycle(C)1 Day(D)1:0,1,1.25,1.75,3,4 hours(h);LY2181308 + Docetaxel: C1 D-1:3,4 h;D1:0,3,4 hPopulation: Participants who received at least 1 dose of study drug and who had an interpretable pharmacokinetic profile
Pharmacokinetics: Area Under the Concentration Curve From Zero to 4 hours (AUC\[0-4\]) for LY2181309 and Docetaxel
Outcome measures
| Measure |
LY2181308 + Docetaxel
n=85 Participants
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=42 Participants
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve From Zero to 4 Hours (AUC[0-4]) for LY2181309 and Docetaxel
|
1642 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 76.4
|
1195 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 104
|
SECONDARY outcome
Timeframe: Docetaxel: Cycle(C)1 Day(D)1:0,1,1.25,1.75,3,4,5,505,513,2521 hours(h);LY2181308 + Docetaxel: C1 D -1:3,4 h;D1:0,3,4,5,5.25,5.75,7,8,120,504,507,509,1008,1512,1515,1517,2016, 2520,2523,2525 hPopulation: Participants who received at least 1 dose of study drug and who had an interpretable pharmacokinetic profile
Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC\[0 ∞\]) of LY2181309 and Docetaxel
Outcome measures
| Measure |
LY2181308 + Docetaxel
n=85 Participants
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=42 Participants
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY2181309 and Docetaxel
|
1905 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 64.7
|
1778 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 87.8
|
SECONDARY outcome
Timeframe: Randomization to date of death from any cause (up to 21.6 months)Population: Participants who received at least 1 dose of study drug. A total of 20 participants were censored in the Docetaxel arm; 41 participants were censored in the LY2181308 + Docetaxel arm.
Overall survival (OS) was the duration from enrollment to death from any cause. For participants who were alive, OS is censored at the date of last contact.
Outcome measures
| Measure |
LY2181308 + Docetaxel
n=114 Participants
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=48 Participants
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Overall Survival (OS)
|
7.9 months
Interval 6.6 to 9.7
|
8.8 months
Interval 5.7 to 13.8
|
SECONDARY outcome
Timeframe: Baseline to the worsening of symptoms (up to 4.6 months)Population: Participants who received at least 1 dose of study drug. A total of 10 participants were censored in the Docetaxel arm; 26 participants were censored in the LY2181308 + Docetaxel arm.
The worsening of symptoms was defined as a 15-millimeter (mm) increase in any 1 symptom on the LCSS. The LCSS is an assessment used to evaluate 6 major symptoms associated with lung malignancies and their effect on overall symptomatic distress, functional activities, and global quality of life. LCSS consists of 2 scales: 1 completed by the participant and 1 completed by the health care professional (which is the average symptom burden index \[ASBI\]). Participant-reported outcomes are assessed using 9 visual analog scales (100-mm horizontal line). Participants indicate intensity of response to the items in question (0 = lowest rating, 100 = highest rating). The LCSS total score ranges from 0 (lowest rating) to 100 (highest rating). The LCSS total score was defined as the mean over all 9 items. Time to worsening of symptoms was censored at the date of the last assessment visit for participants who did not experience any worsening of symptoms as of the data cut-off date.
Outcome measures
| Measure |
LY2181308 + Docetaxel
n=114 Participants
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=48 Participants
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Time to Worsening of Symptoms as Defined by Lung Cancer Symptom Score (LCSS) Questionnaire
|
1.0 Months
Interval 0.7 to 1.0
|
0.8 Months
Interval 0.5 to 1.1
|
SECONDARY outcome
Timeframe: Randomization to the date of first response (up to 12.1 months)Population: Participants who received at least 1 dose of study drug. A total of 47 participants were censored in the Docetaxel arm; 107 participants were censored in the LY2181308 + Docetaxel arm.
Time to objective tumor response was defined as the time from the date of randomization to the first date of documented objective tumor response. Time to objective tumor response was censored at the date of the last assessment visit for participants who had not had documented response as of the data cut-off date. Complete response (CR) was defined as the disappearance of all target lesions; partial response (PR) was defined as at least a 30% decrease in sum of the longest diameter of target lesions.
Outcome measures
| Measure |
LY2181308 + Docetaxel
n=114 Participants
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=48 Participants
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Time to Objective Tumor Response of Partial Response (PR) or Complete Response (CR)
|
NA Months
Due to the high rate of censored participants (107 of 114 participants), the median could not be calculated.
|
NA Months
Due to the high rate of censored participants (47 of 48 participants), the median could not be calculated.
|
SECONDARY outcome
Timeframe: Randomization to the first date of progressive disease (up to 12.9 months)Population: Participants who received at least 1 dose of study drug. A total of 15 participants were censored in the Docetaxel arm; 38 participants were censored in the LY2181308 + Docetaxel arm.
Time to documented disease progression was defined as the time from the date of randomization to the first date of documented progression. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions. Time to documented disease progression was censored at the date of the last assessment visit for participants who had not had documented progressive disease as of the data cut-off date.
Outcome measures
| Measure |
LY2181308 + Docetaxel
n=114 Participants
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=48 Participants
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Time to Documented Disease Progression
|
2.9 Months
Interval 2.0 to 3.7
|
3.4 Months
Interval 2.8 to 5.6
|
SECONDARY outcome
Timeframe: Randomization to the first date of progressive disease (up to 12.1 months)Population: Participants who received at least 1 dose of study drug. A total of 47 participants were censored in the Docetaxel arm; 107 participants were censored in the LY2181308 + Docetaxel arm.
Complete response (CR) was defined as the disappearance of all target lesions; partial response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions.
Outcome measures
| Measure |
LY2181308 + Docetaxel
n=114 Participants
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=48 Participants
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Percent of Participants Having a Partial Response (PR) or a Complete Response (CR)
|
6.1 Percentage of participants
|
2.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Time of response to progressive disease (PD) (approximately 8.7 months)Population: Participants who received at least 1 dose of study drug and achieved CR or PR. A total of 0 participants were censored in the Docetaxel arm; 2 participants were censored in the LY2181308 + Docetaxel arm.
Duration of response was measured from the time measurement criteria were met for complete response (CR) or partial response (PR) (whichever was first recorded) until the first date of documented progressive disease (PD) or death. Complete response (CR) was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions; PD was defined as at least a 20% increase in sum of longest diameter of target lesions. Duration of response was censored at the date of the last assessment or follow-up visit for responders who were still alive and had not progressed.
Outcome measures
| Measure |
LY2181308 + Docetaxel
n=5 Participants
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=1 Participants
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Duration of Response
|
2.8 Months
Interval 2.8 to
The upper range of the confidence interval (CI) could not be calculated due to lack of data (5 response events, 2 participants censored).
|
5.4 Months
The confidence interval (CI) could not be calculated due to lack of data (1 response event, 0 participants censored).
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1Population: Participants who received at least 1 dose of study drug and had evaluable LCSS data.
The worsening of symptoms was defined as a 15-millimeter (mm) increase in any 1 symptom on the Lung Cancer Symptom Scale (LCSS). The LCSS is an assessment used to evaluate 6 major symptoms associated with lung malignancies and their effect on 3 overall symptomatic items: distress, functional activities and global quality of life. LCSS consists of 2 scales: 1 completed by the participant and 1 completed by the health care professional (which is the average symptom burden index \[ASBI\]). Participant-reported outcomes are assessed using 9 visual analog scales (100-mm horizontal line). Participants indicate intensity of response to the items in question (0 = lowest rating, 100 = highest rating). The LCSS total score ranges from 0 (lowest rating) to 100 (highest rating) and was defined as the mean over all 9 items. ASBI was calculated as the mean of six symptom-specific questions from the LCSS, with scores range from 0 (for best outcome) to 100 (for worst outcome).
Outcome measures
| Measure |
LY2181308 + Docetaxel
n=81 Participants
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=38 Participants
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index (ASBI) on Cycle 2 Day 1
|
22 units on a scale
Interval 11.0 to 34.0
|
24 units on a scale
Interval 15.0 to 38.0
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1Population: Participants who received at least 1 dose of study drug and had evaluable LCSS data.
The worsening of symptoms was defined as a 15-millimeter (mm) increase in any 1 symptom on the Lung Cancer Symptom Scale (LCSS). The LCSS is an assessment used to evaluate 6 major symptoms associated with lung malignancies and their effect on 3 overall symptomatic items: distress, functional activities and global quality of life. LCSS consists of 2 scales: 1 completed by the participant and 1 completed by the health care professional (which is the average symptom burden index \[ASBI\]). Participant-reported outcomes are assessed using 9 visual analog scales (100-mm horizontal line). Participants indicate intensity of response to the items in question (0 = lowest rating, 100 = highest rating). The LCSS total score ranges from 0 (lowest rating) to 100 (highest rating) and was defined as the mean over all 9 items.
Outcome measures
| Measure |
LY2181308 + Docetaxel
n=80 Participants
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=37 Participants
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Lung Cancer Symptom Scale (LCSS) Average Total Score at Cycle 2 Day 1
|
27 units on a scale
Interval 11.0 to 38.0
|
30 units on a scale
Interval 20.0 to 41.0
|
Adverse Events
LY2181308 + Docetaxel
Serious events: 65 serious events
Other events: 106 other events
Deaths: 0 deaths
Docetaxel
Serious events: 24 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2181308 + Docetaxel
n=120 participants at risk
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=60 participants at risk
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
4/120 • Number of events 5
|
1.7%
1/60 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.5%
9/120 • Number of events 9
|
8.3%
5/60 • Number of events 6
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.7%
2/120 • Number of events 2
|
0.00%
0/60
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.8%
7/120 • Number of events 7
|
5.0%
3/60 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
2/120 • Number of events 2
|
5.0%
3/60 • Number of events 4
|
|
Cardiac disorders
Cardiac arrest
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Cardiac disorders
Cardiac tamponade
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Cardiac disorders
Pericardial effusion
|
2.5%
3/120 • Number of events 3
|
0.00%
0/60
|
|
Gastrointestinal disorders
Abdominal pain
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Gastrointestinal disorders
Abdominal symptom
|
0.83%
1/120 • Number of events 2
|
0.00%
0/60
|
|
Gastrointestinal disorders
Ascites
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Gastrointestinal disorders
Constipation
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
2/120 • Number of events 2
|
1.7%
1/60 • Number of events 1
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Gastrointestinal disorders
Nausea
|
2.5%
3/120 • Number of events 3
|
0.00%
0/60
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Gastrointestinal disorders
Vomiting
|
0.83%
1/120 • Number of events 2
|
0.00%
0/60
|
|
General disorders
Asthenia
|
2.5%
3/120 • Number of events 3
|
1.7%
1/60 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
General disorders
Chest pain
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
General disorders
Death
|
1.7%
2/120 • Number of events 2
|
0.00%
0/60
|
|
General disorders
Fatigue
|
0.83%
1/120 • Number of events 1
|
1.7%
1/60 • Number of events 1
|
|
General disorders
General physical health deterioration
|
0.83%
1/120 • Number of events 1
|
3.3%
2/60 • Number of events 2
|
|
General disorders
Generalised oedema
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
General disorders
Non-cardiac chest pain
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
General disorders
Oedema peripheral
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
General disorders
Pain
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
General disorders
Pyrexia
|
5.8%
7/120 • Number of events 8
|
5.0%
3/60 • Number of events 3
|
|
Immune system disorders
Anaphylactic reaction
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Immune system disorders
Hypersensitivity
|
1.7%
2/120 • Number of events 2
|
1.7%
1/60 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Infections and infestations
Bronchopneumonia
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Infections and infestations
Cellulitis
|
0.83%
1/120 • Number of events 2
|
0.00%
0/60
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Infections and infestations
Infection
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Infections and infestations
Influenza
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Infections and infestations
Lower respiratory tract infection
|
1.7%
2/120 • Number of events 2
|
0.00%
0/60
|
|
Infections and infestations
Lung abscess
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Infections and infestations
Lung infection
|
2.5%
3/120 • Number of events 4
|
0.00%
0/60
|
|
Infections and infestations
Neutropenic infection
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Infections and infestations
Neutropenic sepsis
|
2.5%
3/120 • Number of events 3
|
3.3%
2/60 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
4.2%
5/120 • Number of events 5
|
3.3%
2/60 • Number of events 2
|
|
Infections and infestations
Sepsis
|
2.5%
3/120 • Number of events 3
|
1.7%
1/60 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Investigations
Blood creatinine increased
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Investigations
C-reactive protein increased
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Investigations
Neutrophil count decreased
|
0.83%
1/120 • Number of events 1
|
1.7%
1/60 • Number of events 1
|
|
Investigations
Weight decreased
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
3/120 • Number of events 3
|
0.00%
0/60
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
2/120 • Number of events 2
|
0.00%
0/60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
2.5%
3/120 • Number of events 3
|
0.00%
0/60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Nervous system disorders
Cerebral ischaemia
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Nervous system disorders
Convulsion
|
0.00%
0/120
|
1.7%
1/60 • Number of events 2
|
|
Nervous system disorders
Headache
|
1.7%
2/120 • Number of events 2
|
0.00%
0/60
|
|
Nervous system disorders
Hemiparesis
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Nervous system disorders
Neuropathy peripheral
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Nervous system disorders
Spinal cord compression
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Nervous system disorders
Syncope
|
0.83%
1/120 • Number of events 1
|
1.7%
1/60 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Psychiatric disorders
Confusional state
|
1.7%
2/120 • Number of events 2
|
0.00%
0/60
|
|
Psychiatric disorders
Mental status changes
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.7%
2/120 • Number of events 2
|
0.00%
0/60
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
3/120 • Number of events 6
|
0.00%
0/60
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/120
|
1.7%
1/60 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.83%
1/120 • Number of events 1
|
3.3%
2/60 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Vascular disorders
Embolism
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Vascular disorders
Hypotension
|
2.5%
3/120 • Number of events 3
|
0.00%
0/60
|
|
Vascular disorders
Lymphoedema
|
0.83%
1/120 • Number of events 1
|
0.00%
0/60
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/120
|
1.7%
1/60 • Number of events 1
|
Other adverse events
| Measure |
LY2181308 + Docetaxel
n=120 participants at risk
LY2181308: 750 milligrams (mg), intravenous (IV), on Day -2 and Day -1 of a 2 day lead-in period; on Day 1, Day 6, and Day 14 for Cycle 1 (1 cycle = 21 days); and once weekly for Days 1 through 21 for Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV), on Day 1 of Cycle 1 (1 cycle = 21 days) and on Day 1 of Cycles 2 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
Docetaxel
n=60 participants at risk
Docetaxel: 75 milligrams/square meter (mg/m\^2), intravenous (IV) on Day 1 of Cycles 1 through 6 (1 cycle = 21 days). After 6 cycles, it was possible to continue therapy until progression of disease, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
36.7%
44/120 • Number of events 61
|
21.7%
13/60 • Number of events 16
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.7%
14/120 • Number of events 26
|
16.7%
10/60 • Number of events 27
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.7%
2/120 • Number of events 3
|
5.0%
3/60 • Number of events 5
|
|
Blood and lymphatic system disorders
Neutropenia
|
29.2%
35/120 • Number of events 53
|
23.3%
14/60 • Number of events 40
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.8%
13/120 • Number of events 20
|
3.3%
2/60 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
10.8%
13/120 • Number of events 15
|
18.3%
11/60 • Number of events 12
|
|
Gastrointestinal disorders
Diarrhoea
|
28.3%
34/120 • Number of events 47
|
36.7%
22/60 • Number of events 28
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
7/120 • Number of events 7
|
11.7%
7/60 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
29.2%
35/120 • Number of events 51
|
20.0%
12/60 • Number of events 14
|
|
Gastrointestinal disorders
Oral pain
|
1.7%
2/120 • Number of events 3
|
5.0%
3/60 • Number of events 3
|
|
Gastrointestinal disorders
Stomatitis
|
10.8%
13/120 • Number of events 13
|
6.7%
4/60 • Number of events 12
|
|
Gastrointestinal disorders
Vomiting
|
19.2%
23/120 • Number of events 31
|
15.0%
9/60 • Number of events 10
|
|
General disorders
Chest pain
|
5.8%
7/120 • Number of events 8
|
5.0%
3/60 • Number of events 3
|
|
General disorders
Chills
|
9.2%
11/120 • Number of events 13
|
0.00%
0/60
|
|
General disorders
Fatigue
|
44.2%
53/120 • Number of events 70
|
40.0%
24/60 • Number of events 32
|
|
General disorders
Mucosal inflammation
|
6.7%
8/120 • Number of events 11
|
3.3%
2/60 • Number of events 3
|
|
General disorders
Oedema peripheral
|
10.8%
13/120 • Number of events 16
|
5.0%
3/60 • Number of events 4
|
|
General disorders
Pain
|
0.83%
1/120 • Number of events 1
|
10.0%
6/60 • Number of events 7
|
|
General disorders
Pyrexia
|
21.7%
26/120 • Number of events 33
|
6.7%
4/60 • Number of events 5
|
|
Infections and infestations
Oral candidiasis
|
4.2%
5/120 • Number of events 5
|
5.0%
3/60 • Number of events 5
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
24/120 • Number of events 33
|
20.0%
12/60 • Number of events 14
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
4/120 • Number of events 4
|
5.0%
3/60 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.8%
7/120 • Number of events 9
|
6.7%
4/60 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
6/120 • Number of events 6
|
5.0%
3/60 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
9/120 • Number of events 13
|
5.0%
3/60 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
4/120 • Number of events 4
|
6.7%
4/60 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
2/120 • Number of events 2
|
5.0%
3/60 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
9/120 • Number of events 13
|
5.0%
3/60 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
8/120 • Number of events 8
|
6.7%
4/60 • Number of events 5
|
|
Nervous system disorders
Ageusia
|
0.00%
0/120
|
5.0%
3/60 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
5.0%
6/120 • Number of events 6
|
11.7%
7/60 • Number of events 8
|
|
Nervous system disorders
Dysgeusia
|
5.8%
7/120 • Number of events 7
|
11.7%
7/60 • Number of events 7
|
|
Nervous system disorders
Headache
|
8.3%
10/120 • Number of events 11
|
6.7%
4/60 • Number of events 4
|
|
Nervous system disorders
Paraesthesia
|
2.5%
3/120 • Number of events 5
|
5.0%
3/60 • Number of events 5
|
|
Nervous system disorders
Polyneuropathy
|
0.83%
1/120 • Number of events 1
|
5.0%
3/60 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
5.8%
7/120 • Number of events 7
|
6.7%
4/60 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
15/120 • Number of events 17
|
16.7%
10/60 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
24/120 • Number of events 27
|
20.0%
12/60 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
6/120 • Number of events 7
|
5.0%
3/60 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.5%
3/120 • Number of events 4
|
5.0%
3/60 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.83%
1/120 • Number of events 1
|
5.0%
3/60 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
8/120 • Number of events 9
|
0.00%
0/60
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
27.5%
33/120 • Number of events 33
|
21.7%
13/60 • Number of events 13
|
|
Vascular disorders
Hypotension
|
8.3%
10/120 • Number of events 10
|
5.0%
3/60 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60