Trial Outcomes & Findings for A Study of LY2523355 in Participants With Breast Cancer (NCT NCT01416389)
NCT ID: NCT01416389
Last Updated: 2019-09-18
Results Overview
The log ratio of tumor size at Cycle 2 to tumor size at baseline is calculated for each participant, where the tumor size is the sum of the target lesion measurements at each assessment.
COMPLETED
PHASE2
39 participants
Baseline up to end of Cycle 2 (Day 42)
2019-09-18
Participant Flow
Participants completed the study if they had at least 1 dose of study drug in Cycle 2 (or later) and had at least 1 post-baseline radiological tumor assessment or if the participant had a progression of disease or death. Non-completers were those that were lost to follow-up or who withdrew their consent to trial participation.
Participant milestones
| Measure |
LY2523355 + Pegfilgrastim or Filgrastim
LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day \[mg/m\^2/day\]). One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.
Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Ixabepilone
Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.
Dosage determined by calculating participant's body surface area (40 mg/m\^2).
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
13
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
26
|
13
|
|
Overall Study
COMPLETED
|
23
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
LY2523355 + Pegfilgrastim or Filgrastim
LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day \[mg/m\^2/day\]). One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.
Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Ixabepilone
Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.
Dosage determined by calculating participant's body surface area (40 mg/m\^2).
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Started New Therapy
|
2
|
0
|
Baseline Characteristics
A Study of LY2523355 in Participants With Breast Cancer
Baseline characteristics by cohort
| Measure |
LY2523355 + Pegfilgrastim or Filgrastim
n=26 Participants
LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day \[mg/m\^2/day\]).
Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Ixabepilone
n=13 Participants
Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.
Dosage determined by calculating participant's body surface area (40 mg/m\^2).
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
13 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of Cycle 2 (Day 42)Population: Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone) and who had target lesion measurements at both baseline and the end of Cycle 2. One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.
The log ratio of tumor size at Cycle 2 to tumor size at baseline is calculated for each participant, where the tumor size is the sum of the target lesion measurements at each assessment.
Outcome measures
| Measure |
LY2523355 + Pegfilgrastim or Filgrastim
n=17 Participants
LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day \[mg/m\^2/day\]).
Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Ixabepilone
n=11 Participants
Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.
Dosage determined by calculating participant's body surface area (40 mg/m\^2).
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
|---|---|---|
|
Change in Tumor Size (CTS) From Baseline to the End of Cycle 2
|
-0.0 log ratio of end of Cycle 2 to baseline
Standard Deviation 0.08
|
-0.1 log ratio of end of Cycle 2 to baseline
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Baseline to measured progressive disease or date of death from any cause (up to 423 days)Population: Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.
Outcome measures
| Measure |
LY2523355 + Pegfilgrastim or Filgrastim
n=26 Participants
LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day \[mg/m\^2/day\]).
Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Ixabepilone
n=13 Participants
Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.
Dosage determined by calculating participant's body surface area (40 mg/m\^2).
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
|---|---|---|
|
Percentage of Participants Achieving an Overall Response (Overall Response Rate)
|
3.8 percentage of responders
Interval 0.2 to 17.0
|
7.7 percentage of responders
Interval 0.4 to 31.6
|
SECONDARY outcome
Timeframe: Baseline to measured progressive disease or date of death from any cause (up to 423 days)Population: Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). The total number of participants censored is 7. One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.
Progression-free survival (PFS) is the time from the date of randomization to the first date of progressive disease (PD) or death due to any cause, whichever occurs first. PD is as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines, and is defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 millimeter (mm) (the appearance of 1 or more new lesions was considered progression). Kaplan-Meier analysis was performed on the observed distribution of PFS. Participants were censored from analysis for the following reasons: lack of disease assessment, lost to follow-up, and further anticancer therapy started. Median PFS is presented.
Outcome measures
| Measure |
LY2523355 + Pegfilgrastim or Filgrastim
n=22 Participants
LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day \[mg/m\^2/day\]).
Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Ixabepilone
n=10 Participants
Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.
Dosage determined by calculating participant's body surface area (40 mg/m\^2).
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
1.71 months
Interval 1.25 to 2.79
|
2.76 months
Interval 1.41 to 4.8
|
SECONDARY outcome
Timeframe: Baseline to measured progressive disease or date of death from any cause (up to 423 days)Population: Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.
Clinical benefit rate is the proportion of participants who achieve a best response of complete response (CR), partial response (PR), or stable disease (SD) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD is neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease, taking as reference the smallest sum diameter since treatment started. Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with measurable disease, multiplied by 100.
Outcome measures
| Measure |
LY2523355 + Pegfilgrastim or Filgrastim
n=26 Participants
LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day \[mg/m\^2/day\]).
Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Ixabepilone
n=13 Participants
Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.
Dosage determined by calculating participant's body surface area (40 mg/m\^2).
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
|---|---|---|
|
Percentage of Participants Achieving a Clinical Benefit (Clinical Benefit Rate)
|
46.2 percentage of responders
Interval 29.2 to 63.8
|
61.5 percentage of responders
Interval 35.5 to 83.4
|
SECONDARY outcome
Timeframe: Cycle 1: Day 1 and Day 3Population: Participants who received 1 dose of LY2523355 on Day 1 and Day 3 of Cycle 1 and who have evaluable pharmacokinetic data to enable estimation of the LY2523355 Cmax on Day 1 and Day 3 of Cycle 1. One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2, and is not included in this analysis.
Cmax is the maximum plasma concentration of LY2523355 after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.
Outcome measures
| Measure |
LY2523355 + Pegfilgrastim or Filgrastim
n=24 Participants
LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day \[mg/m\^2/day\]).
Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Ixabepilone
Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.
Dosage determined by calculating participant's body surface area (40 mg/m\^2).
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
|---|---|---|
|
Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355
Cycle 1, Day 1
|
161 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 81
|
—
|
|
Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355
Cycle 1, Day 3
|
150 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Day 1 and Day 3Population: Participants who received 1 dose of LY2523355 on Day 1 and Day 3 of Cycle 1 and who have evaluable pharmacokinetic data to enable estimation of the LSN2546307 Cmax on Day 1 and Day 3 of Cycle 1.One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2, and is not included in this analysis.
Cmax is the maximum plasma concentration of LSN2546307 (metabolite) after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.
Outcome measures
| Measure |
LY2523355 + Pegfilgrastim or Filgrastim
n=24 Participants
LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day \[mg/m\^2/day\]).
Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Ixabepilone
Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.
Dosage determined by calculating participant's body surface area (40 mg/m\^2).
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
|---|---|---|
|
Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LSN2546307
Cycle 1, Day 1
|
5.08 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 57
|
—
|
|
Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LSN2546307
Cycle1, Day 3
|
5.53 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 67
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Day 1 and Day 3Population: Participants who received 1-dose of LY2523355 on Day 1 and Day 3 of Cycle 1 and who have evaluable pharmacokinetic data to enable estimation of the LY2523355 Cmax on Day 1 and Day 3 of Cycle 1. One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2, and is not included in this analysis.
The intracycle accumulation ratio (Ra) is defined as the LY2523355 Cmax on Day 3 of Cycle 1 to the LY2523355 Cmax on Day 1 of Cycle 1 after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.
Outcome measures
| Measure |
LY2523355 + Pegfilgrastim or Filgrastim
n=21 Participants
LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day \[mg/m\^2/day\]).
Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Ixabepilone
Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.
Dosage determined by calculating participant's body surface area (40 mg/m\^2).
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
|---|---|---|
|
Pharmacokinetics, Intracycle Accumulation Ration (Ra) of LY2523355
|
0.92 unitless ratio
Geometric Coefficient of Variation 77
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through end of treatment follow-up (up to 423 days)Population: Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.
The percentage of participants who died through the follow-up period of the study; the cause of death was not captured. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
LY2523355 + Pegfilgrastim or Filgrastim
n=26 Participants
LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day \[mg/m\^2/day\]).
Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Ixabepilone
n=13 Participants
Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.
Dosage determined by calculating participant's body surface area (40 mg/m\^2).
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
|---|---|---|
|
Percentage of Deaths on Study Through the Follow-up Period
|
7.7 percentage of participants
|
15.4 percentage of participants
|
Adverse Events
LY2523355 + Pegfilgrastim or Filgrastim
Ixabepilone
Serious adverse events
| Measure |
LY2523355 + Pegfilgrastim or Filgrastim
n=26 participants at risk
LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day \[mg/m\^2/day\]). One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.
Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Ixabepilone
n=13 participants at risk
Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.
Dosage determined by calculating participant's body surface area (40 mg/m\^2).
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Pancreatitis
|
3.8%
1/26 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
2/26 • Number of events 2
|
0.00%
0/13
|
|
General disorders
Pain
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Number of events 1
|
0.00%
0/13
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
3.8%
1/26 • Number of events 1
|
0.00%
0/13
|
|
Investigations
Ammonia increased
|
3.8%
1/26 • Number of events 1
|
0.00%
0/13
|
|
Nervous system disorders
Hepatic encephalopathy
|
3.8%
1/26 • Number of events 1
|
0.00%
0/13
|
Other adverse events
| Measure |
LY2523355 + Pegfilgrastim or Filgrastim
n=26 participants at risk
LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day \[mg/m\^2/day\]). One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.
Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Ixabepilone
n=13 participants at risk
Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.
Dosage determined by calculating participant's body surface area (40 mg/m\^2).
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
30.8%
8/26 • Number of events 8
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.5%
3/26 • Number of events 3
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.1%
6/26 • Number of events 6
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.5%
3/26 • Number of events 3
|
15.4%
2/13 • Number of events 2
|
|
Eye disorders
Lacrimation increased
|
7.7%
2/26 • Number of events 2
|
0.00%
0/13
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
11.5%
3/26 • Number of events 3
|
23.1%
3/13 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
2/26 • Number of events 2
|
23.1%
3/13 • Number of events 3
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
30.8%
8/26 • Number of events 8
|
38.5%
5/13 • Number of events 5
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
7.7%
2/26 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
15.4%
4/26 • Number of events 4
|
0.00%
0/13
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
2/26 • Number of events 2
|
23.1%
3/13 • Number of events 3
|
|
General disorders
Asthenia
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Chills
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Device malfunction
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Fatigue
|
50.0%
13/26 • Number of events 13
|
38.5%
5/13 • Number of events 5
|
|
General disorders
Mucosal inflammation
|
3.8%
1/26 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Oedema
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Oedema peripheral
|
11.5%
3/26 • Number of events 3
|
0.00%
0/13
|
|
General disorders
Pain
|
7.7%
2/26 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pyrexia
|
7.7%
2/26 • Number of events 2
|
0.00%
0/13
|
|
Immune system disorders
Hypersensitivity
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Blood bilirubin decreased
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Globulins decreased
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Platelet count decreased
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Weight decreased
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
11.5%
3/26 • Number of events 3
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.1%
6/26 • Number of events 6
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Number of events 1
|
23.1%
3/13 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.7%
2/26 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.5%
3/26 • Number of events 3
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
2/26 • Number of events 2
|
38.5%
5/13 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.5%
3/26 • Number of events 3
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.8%
1/26 • Number of events 1
|
23.1%
3/13 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
2/26 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
11.5%
3/26 • Number of events 3
|
0.00%
0/13
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
11.5%
3/26 • Number of events 3
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/26
|
30.8%
4/13 • Number of events 4
|
|
Nervous system disorders
Paraesthesia
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Parosmia
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.8%
1/26 • Number of events 1
|
23.1%
3/13 • Number of events 3
|
|
Nervous system disorders
Tremor
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
11.5%
3/26 • Number of events 3
|
15.4%
2/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
4/26 • Number of events 4
|
15.4%
2/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.2%
5/26 • Number of events 5
|
15.4%
2/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/26
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Hot flush
|
3.8%
1/26 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60