Study of LY2181308 in Combination With Docetaxel Versus D... | NCT01107444

ID	Type	Description	Link
H8Z-MC-JACW	Other Identifier	Eli Lilly and Company
2009-017591-24	EudraCT Number

Label	Type	Description	Intervention Names
LY2181308 + Docetaxel	Experimental	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.	Drug: Docetaxel Drug: LY2181308
Docetaxel	Active Comparator	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.	Drug: Docetaxel

Name	Type	Description	Arm Group Labels	Other Names
Docetaxel	Drug	Administered intravenously	Docetaxel LY2181308 + Docetaxel

Measure	Description	Time Frame
Change From Baseline in Tumor Size to 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.	Baseline, End of Cycle 2 (1 cycle = 21 days)

Measure	Description	Time Frame
Number of Participants With Characterization of Toxicities as Defined by Common Terminology Criteria for Adverse Events (CTCAE) Coding	Safety analyses included listings and/or summaries of the following: CTCAE for laboratory and non-laboratory parameters possibly related to study drug; 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); Dose adjustments due to adverse events (AEs).

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT- 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Los Angeles	California	90048

PubMed Identifier	Type	Citation	Retractions
25436803	Derived	Natale R, Blackhall F, Kowalski D, Ramlau R, Bepler G, Grossi F, Lerchenmuller C, Pinder-Schenck M, Mezger J, Danson S, Gadgeel SM, Summers Y, Callies S, Andre V, Das M, Lahn M, Talbot D. Evaluation of antitumor activity using change in tumor size of the survivin antisense oligonucleotide LY2181308 in combination with docetaxel for second-line treatment of patients with non-small-cell lung cancer: a randomized open-label phase II study. J Thorac Oncol. 2014 Nov;9(11):1704-8. doi: 10.1097/JTO.0000000000000285.

ID	Title	Description
FG000	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.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Tumor Size to 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.

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.

Posted

Mean

Standard Deviation

Log Ratio of Tumor Size

Baseline, End of Cycle 2 (1 cycle = 21 days)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00082 OG00142

Title

Denominators

Categories

Title	Measurements
	OG0001.06± 0.2 OG0011.01± 0.13

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 1 sided		0.284	The t-test was based on the logarithm of the ratio of tumor size at Cycle 2 to that at baseline as this measure follows a normal distribution.													Superiority or Other (legacy)

Secondary

Number of Participants With Characterization of Toxicities as Defined by Common Terminology Criteria for Adverse Events (CTCAE) Coding

Safety analyses included listings and/or summaries of the following:

CTCAE for laboratory and non-laboratory parameters possibly related to study drug;
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);
Dose adjustments due to adverse events (AEs).

Participants who received at least 1 dose of study drug.

Posted

Count of Participants

Participants

Randomization through long-term follow up (up to 21.6 months)

ID	Title	Description
OG000	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.
OG001

Secondary

Progression Free Survival (PFS)

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.

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.

Posted

Median

95% Confidence Interval

Months

Randomization to the first date of progressive disease or death from any cause (up to 12.88 months)

ID	Title	Description
OG000	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.
OG001	Docetaxel

Secondary

Pharmacokinetics: Area Under the Concentration Curve From Zero to 4 Hours (AUC[0-4]) for LY2181309 and Docetaxel

Pharmacokinetics: Area Under the Concentration Curve From Zero to 4 hours (AUC[0-4]) for LY2181309 and Docetaxel

Participants who received at least 1 dose of study drug and who had an interpretable pharmacokinetic profile

Posted

Geometric Mean

Geometric Coefficient of Variation

nanograms*hours per milliliter (ng*h/mL)

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 h

ID	Title	Description
OG000	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/meters squared (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.
OG001	Docetaxel	Docetaxel: 75 milligrams/meters squared (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

Secondary

Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY2181309 and Docetaxel

Participants who received at least 1 dose of study drug and who had an interpretable pharmacokinetic profile

Posted

Geometric Mean

Geometric Coefficient of Variation

nanograms*hours per milliliter (ng*h/mL)

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 h

ID	Title	Description
OG000	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/meters squared (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.
OG001	Docetaxel	Docetaxel: 75 milligrams/meters squared (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

Secondary

Overall Survival (OS)

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.

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.

Posted

Median

90% Confidence Interval

months

Randomization to date of death from any cause (up to 21.6 months)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Time to Worsening of Symptoms as Defined by Lung Cancer Symptom Score (LCSS) Questionnaire

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.

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.

Posted

Median

90% Confidence Interval

Months

Baseline to the worsening of symptoms (up to 4.6 months)

ID	Title	Description
OG000	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.

Secondary

Time to Objective Tumor Response of Partial Response (PR) or Complete Response (CR)

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.

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.

Posted

Median

90% Confidence Interval

Months

Randomization to the date of first response (up to 12.1 months)

ID	Title	Description
OG000	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.

Secondary

Time to Documented Disease Progression

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.

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.

Posted

Median

90% Confidence Interval

Months

Randomization to the first date of progressive disease (up to 12.9 months)

ID	Title	Description
OG000	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.
OG001	Docetaxel

Secondary

Percent of Participants Having a Partial Response (PR) or a Complete Response (CR)

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.

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.

Posted

Number

Percentage of participants

Randomization to the first date of progressive disease (up to 12.1 months)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Duration of Response

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.

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.

Posted

Median

90% Confidence Interval

Months

Time of response to progressive disease (PD) (approximately 8.7 months)

ID	Title	Description
OG000	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/meters squared (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.

Secondary

Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index (ASBI) on Cycle 2 Day 1

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).

Participants who received at least 1 dose of study drug and had evaluable LCSS data.

Posted

Median

Inter-Quartile Range

units on a scale

Cycle 2 Day 1

ID	Title	Description
OG000	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.

Secondary

Lung Cancer Symptom Scale (LCSS) Average Total Score at Cycle 2 Day 1

Participants who received at least 1 dose of study drug and had evaluable LCSS data.

Posted

Median

Inter-Quartile Range

units on a scale

Cycle 2 Day 1

ID	Title	Description
OG000	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/meters squared (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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	15.0	Systematic Assessment		EG0005 events4 affected120 at risk EG0011 events1 affected60 at risk
Febrile neutropenia	Blood and lymphatic system disorders	15.0	Systematic Assessment		EG0009 events9 affected120 at risk EG0016 events5 affected60 at risk
Leukopenia	Blood and lymphatic system disorders	15.0	Systematic Assessment		EG0002 events2 affected120 at risk EG0010 events0 affected60 at risk
Neutropenia	Blood and lymphatic system disorders	15.0	Systematic Assessment		EG0007 events7 affected120 at risk EG0014 events3 affected60 at risk
Thrombocytopenia	Blood and lymphatic system disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Atrial fibrillation	Cardiac disorders	15.0	Systematic Assessment		EG0002 events2 affected120 at risk EG0014 events3 affected60 at risk
Cardiac arrest	Cardiac disorders	15.0	Systematic Assessment	Event resulted in death	EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Cardiac tamponade	Cardiac disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Left ventricular dysfunction	Cardiac disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Pericardial effusion	Cardiac disorders	15.0	Systematic Assessment		EG0003 events3 affected120 at risk EG0010 events0 affected60 at risk
Abdominal pain	Gastrointestinal disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Abdominal symptom	Gastrointestinal disorders	15.0	Systematic Assessment		EG0002 events1 affected120 at risk EG0010 events0 affected60 at risk
Ascites	Gastrointestinal disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Constipation	Gastrointestinal disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Diarrhoea	Gastrointestinal disorders	15.0	Systematic Assessment		EG0002 events2 affected120 at risk EG0011 events1 affected60 at risk
Diverticular perforation	Gastrointestinal disorders	15.0	Systematic Assessment		EG0000 events0 affected120 at risk EG0011 events1 affected60 at risk
Gastritis	Gastrointestinal disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Nausea	Gastrointestinal disorders	15.0	Systematic Assessment		EG0003 events3 affected120 at risk EG0010 events0 affected60 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	15.0	Systematic Assessment	Event resulted in death	EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Vomiting	Gastrointestinal disorders	15.0	Systematic Assessment		EG0002 events1 affected120 at risk EG0010 events0 affected60 at risk
Asthenia	General disorders	15.0	Systematic Assessment		EG0003 events3 affected120 at risk EG0011 events1 affected60 at risk
Chest discomfort	General disorders	15.0	Systematic Assessment		EG0000 events0 affected120 at risk EG0011 events1 affected60 at risk
Chest pain	General disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Death	General disorders	15.0	Systematic Assessment		EG0002 events2 affected120 at risk EG0010 events0 affected60 at risk
Fatigue	General disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0011 events1 affected60 at risk
General physical health deterioration	General disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0012 events2 affected60 at risk
Generalised oedema	General disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Non-cardiac chest pain	General disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Oedema peripheral	General disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Pain	General disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Pyrexia	General disorders	15.0	Systematic Assessment		EG0008 events7 affected120 at risk EG0013 events3 affected60 at risk
Anaphylactic reaction	Immune system disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Hypersensitivity	Immune system disorders	15.0	Systematic Assessment		EG0002 events2 affected120 at risk EG0011 events1 affected60 at risk
Bronchitis	Infections and infestations	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Bronchopneumonia	Infections and infestations	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Cellulitis	Infections and infestations	15.0	Systematic Assessment		EG0002 events1 affected120 at risk EG0010 events0 affected60 at risk
Diverticulitis	Infections and infestations	15.0	Systematic Assessment		EG0000 events0 affected120 at risk EG0011 events1 affected60 at risk
Gastroenteritis	Infections and infestations	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Infection	Infections and infestations	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Influenza	Infections and infestations	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Lower respiratory tract infection	Infections and infestations	15.0	Systematic Assessment		EG0002 events2 affected120 at risk EG0010 events0 affected60 at risk
Lung abscess	Infections and infestations	15.0	Systematic Assessment		EG0000 events0 affected120 at risk EG0011 events1 affected60 at risk
Lung infection	Infections and infestations	15.0	Systematic Assessment		EG0004 events3 affected120 at risk EG0010 events0 affected60 at risk
Neutropenic infection	Infections and infestations	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Neutropenic sepsis	Infections and infestations	15.0	Systematic Assessment		EG0003 events3 affected120 at risk EG0012 events2 affected60 at risk
Pneumonia	Infections and infestations	15.0	Systematic Assessment		EG0005 events5 affected120 at risk EG0012 events2 affected60 at risk
Sepsis	Infections and infestations	15.0	Systematic Assessment		EG0003 events3 affected120 at risk EG0011 events1 affected60 at risk
Upper respiratory tract infection	Infections and infestations	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Subdural haematoma	Injury, poisoning and procedural complications	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Blood creatinine increased	Investigations	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
C-reactive protein increased	Investigations	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Neutrophil count decreased	Investigations	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0011 events1 affected60 at risk
Weight decreased	Investigations	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Dehydration	Metabolism and nutrition disorders	15.0	Systematic Assessment		EG0003 events3 affected120 at risk EG0010 events0 affected60 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Hyponatraemia	Metabolism and nutrition disorders	15.0	Systematic Assessment		EG0000 events0 affected120 at risk EG0011 events1 affected60 at risk
Bone pain	Musculoskeletal and connective tissue disorders	15.0	Systematic Assessment		EG0002 events2 affected120 at risk EG0010 events0 affected60 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	15.0	Systematic Assessment		EG0003 events3 affected120 at risk EG0010 events0 affected60 at risk
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Cerebral ischaemia	Nervous system disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Convulsion	Nervous system disorders	15.0	Systematic Assessment		EG0000 events0 affected120 at risk EG0012 events1 affected60 at risk
Headache	Nervous system disorders	15.0	Systematic Assessment		EG0002 events2 affected120 at risk EG0010 events0 affected60 at risk
Hemiparesis	Nervous system disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Neuropathy peripheral	Nervous system disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Peripheral sensory neuropathy	Nervous system disorders	15.0	Systematic Assessment		EG0000 events0 affected120 at risk EG0011 events1 affected60 at risk
Spinal cord compression	Nervous system disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Syncope	Nervous system disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0011 events1 affected60 at risk
Transient ischaemic attack	Nervous system disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Confusional state	Psychiatric disorders	15.0	Systematic Assessment		EG0002 events2 affected120 at risk EG0010 events0 affected60 at risk
Mental status changes	Psychiatric disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Renal impairment	Renal and urinary disorders	15.0	Systematic Assessment		EG0000 events0 affected120 at risk EG0011 events1 affected60 at risk
Urinary retention	Renal and urinary disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment		EG0002 events2 affected120 at risk EG0010 events0 affected60 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment		EG0006 events3 affected120 at risk EG0010 events0 affected60 at risk
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment		EG0000 events0 affected120 at risk EG0012 events1 affected60 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment		EG0000 events0 affected120 at risk EG0011 events1 affected60 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Laryngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0012 events2 affected60 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Arterial occlusive disease	Vascular disorders	15.0	Systematic Assessment		EG0000 events0 affected120 at risk EG0011 events1 affected60 at risk
Embolism	Vascular disorders	15.0	Systematic Assessment		EG0000 events0 affected120 at risk EG0011 events1 affected60 at risk
Hypotension	Vascular disorders	15.0	Systematic Assessment		EG0003 events3 affected120 at risk EG0010 events0 affected60 at risk
Lymphoedema	Vascular disorders	15.0	Systematic Assessment		EG0001 events1 affected120 at risk EG0010 events0 affected60 at risk
Orthostatic hypotension	Vascular disorders	15.0	Systematic Assessment		EG0000 events0 affected120 at risk EG0011 events1 affected60 at risk
Superior vena cava syndrome	Vascular disorders	15.0	Systematic Assessment		EG0000 events0 affected120 at risk EG0011 events1 affected60 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	15.0	Systematic Assessment	EG00061 events44 affected120 at risk EG00116 events13 affected60 at risk
Leukopenia	Blood and lymphatic system disorders	15.0	Systematic Assessment	EG00026 events14 affected120 at risk EG00127 events10 affected60 at risk
Lymphopenia	Blood and lymphatic system disorders	15.0	Systematic Assessment	EG0003 events2 affected120 at risk EG0015 events3 affected60 at risk
Neutropenia	Blood and lymphatic system disorders	15.0	Systematic Assessment	EG00053 events35 affected120 at risk EG00140 events14 affected60 at risk
Thrombocytopenia	Blood and lymphatic system disorders	15.0	Systematic Assessment	EG00020 events13 affected120 at risk EG0012 events2 affected60 at risk
Constipation	Gastrointestinal disorders	15.0	Systematic Assessment	EG00015 events13 affected120 at risk EG00112 events11 affected60 at risk
Diarrhoea	Gastrointestinal disorders	15.0	Systematic Assessment	EG00047 events34 affected120 at risk EG00128 events22 affected60 at risk
Dyspepsia	Gastrointestinal disorders	15.0	Systematic Assessment	EG0007 events7 affected120 at risk EG0017 events7 affected60 at risk
Nausea	Gastrointestinal disorders	15.0	Systematic Assessment	EG00051 events35 affected120 at risk EG00114 events12 affected60 at risk
Oral pain	Gastrointestinal disorders	15.0	Systematic Assessment	EG0003 events2 affected120 at risk EG0013 events3 affected60 at risk
Stomatitis	Gastrointestinal disorders	15.0	Systematic Assessment	EG00013 events13 affected120 at risk EG00112 events4 affected60 at risk
Vomiting	Gastrointestinal disorders	15.0	Systematic Assessment	EG00031 events23 affected120 at risk EG00110 events9 affected60 at risk
Chest pain	General disorders	15.0	Systematic Assessment	EG0008 events7 affected120 at risk EG0013 events3 affected60 at risk
Chills	General disorders	15.0	Systematic Assessment	EG00013 events11 affected120 at risk EG0010 events0 affected60 at risk
Fatigue	General disorders	15.0	Systematic Assessment	EG00070 events53 affected120 at risk EG00132 events24 affected60 at risk
Mucosal inflammation	General disorders	15.0	Systematic Assessment	EG00011 events8 affected120 at risk EG0013 events2 affected60 at risk
Oedema peripheral	General disorders	15.0	Systematic Assessment	EG00016 events13 affected120 at risk EG0014 events3 affected60 at risk
Pain	General disorders	15.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0017 events6 affected60 at risk
Pyrexia	General disorders	15.0	Systematic Assessment	EG00033 events26 affected120 at risk EG0015 events4 affected60 at risk
Oral candidiasis	Infections and infestations	15.0	Systematic Assessment	EG0005 events5 affected120 at risk EG0015 events3 affected60 at risk
Decreased appetite	Metabolism and nutrition disorders	15.0	Systematic Assessment	EG00033 events24 affected120 at risk EG00114 events12 affected60 at risk
Dehydration	Metabolism and nutrition disorders	15.0	Systematic Assessment	EG0004 events4 affected120 at risk EG0013 events3 affected60 at risk
Hyperglycaemia	Metabolism and nutrition disorders	15.0	Systematic Assessment	EG0009 events7 affected120 at risk EG0017 events4 affected60 at risk
Hypokalaemia	Metabolism and nutrition disorders	15.0	Systematic Assessment	EG0006 events6 affected120 at risk EG0013 events3 affected60 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	15.0	Systematic Assessment	EG00013 events9 affected120 at risk EG0014 events3 affected60 at risk
Back pain	Musculoskeletal and connective tissue disorders	15.0	Systematic Assessment	EG0004 events4 affected120 at risk EG0014 events4 affected60 at risk
Bone pain	Musculoskeletal and connective tissue disorders	15.0	Systematic Assessment	EG0002 events2 affected120 at risk EG0013 events3 affected60 at risk
Myalgia	Musculoskeletal and connective tissue disorders	15.0	Systematic Assessment	EG00013 events9 affected120 at risk EG0015 events3 affected60 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	15.0	Systematic Assessment	EG0008 events8 affected120 at risk EG0015 events4 affected60 at risk
Ageusia	Nervous system disorders	15.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0014 events3 affected60 at risk
Dizziness	Nervous system disorders	15.0	Systematic Assessment	EG0006 events6 affected120 at risk EG0018 events7 affected60 at risk
Dysgeusia	Nervous system disorders	15.0	Systematic Assessment	EG0007 events7 affected120 at risk EG0017 events7 affected60 at risk
Headache	Nervous system disorders	15.0	Systematic Assessment	EG00011 events10 affected120 at risk EG0014 events4 affected60 at risk
Paraesthesia	Nervous system disorders	15.0	Systematic Assessment	EG0005 events3 affected120 at risk EG0015 events3 affected60 at risk
Polyneuropathy	Nervous system disorders	15.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0014 events3 affected60 at risk
Insomnia	Psychiatric disorders	15.0	Systematic Assessment	EG0007 events7 affected120 at risk EG0016 events4 affected60 at risk
Cough	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment	EG00017 events15 affected120 at risk EG00110 events10 affected60 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment	EG00027 events24 affected120 at risk EG00113 events12 affected60 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment	EG0007 events6 affected120 at risk EG0013 events3 affected60 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment	EG0004 events3 affected120 at risk EG0013 events3 affected60 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0013 events3 affected60 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	15.0	Systematic Assessment	EG0009 events8 affected120 at risk EG0010 events0 affected60 at risk
Alopecia	Skin and subcutaneous tissue disorders	15.0	Systematic Assessment	EG00033 events33 affected120 at risk EG00113 events13 affected60 at risk
Hypotension	Vascular disorders	15.0	Systematic Assessment	EG00010 events10 affected120 at risk EG0013 events3 affected60 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			65	120	106	120
EG001	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.			24	60	44	60