Trial Outcomes & Findings for A Study for Participants With Small-Cell Lung Cancer (NCT NCT01025284)
NCT ID: NCT01025284
Last Updated: 2019-09-17
Results Overview
The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR, then divided by the total number of participants treated, then multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Date of enrollment to date of measured progressive disease up to 99.6 weeks
Results posted on
2019-09-17
Participant Flow
This is a nonrandomized, open-label, 2-part study.
Participant milestones
| Measure |
Part A - 8 mg/m²/Day
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 5 mg/m²/Day
5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
18
|
8
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
38
|
18
|
8
|
|
Overall Study
COMPLETED
|
38
|
16
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Part A - 8 mg/m²/Day
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 5 mg/m²/Day
5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
|---|---|---|---|
|
Overall Study
Investigator Decision
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
A Study for Participants With Small-Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Part A - 8 mg/m²/Day
n=38 Participants
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 5 mg/m²/Day
n=18 Participants
5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
n=8 Participants
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.88 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
63.33 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
63.40 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
64.26 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
25 participants
n=5 Participants
|
13 participants
n=7 Participants
|
3 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Date of enrollment to date of measured progressive disease up to 99.6 weeksPopulation: All participants who received at least 1 dose of study drug in Part A.
The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR, then divided by the total number of participants treated, then multiplied by 100.
Outcome measures
| Measure |
Part A
n=38 Participants
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate)
|
2.6 percentage of participants
Interval 0.1 to 11.9
|
—
|
PRIMARY outcome
Timeframe: Date of enrollment to date of measured progressive disease up to 18.1 weeksPopulation: All participants who received at least 1 dose of study drug in Part B.
Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.
Outcome measures
| Measure |
Part A
n=26 Participants
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate)
|
26.9 percentage of participants
Interval 13.4 to 44.7
|
—
|
SECONDARY outcome
Timeframe: Date of enrollment to date of measured progressive disease or date of death from any cause up to 99.6 weeksPopulation: All participants who received at least 1 dose of study drug in Part A. The numbers of participants censored are 4.
Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment.
Outcome measures
| Measure |
Part A
n=38 Participants
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Part A: Progression-Free Survival
|
5.3 weeks
Interval 5.1 to 5.7
|
—
|
SECONDARY outcome
Timeframe: Date of enrollment to date of measured progressive disease or date of death from any cause up to 18.1 weeksPopulation: All participants who received at least 1 dose of study drug in Part B. The numbers of participants censored are 4.
Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment.
Outcome measures
| Measure |
Part A
n=26 Participants
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Part B: Progression-Free Survival
|
6.1 weeks
Interval 5.6 to 7.4
|
—
|
SECONDARY outcome
Timeframe: Date of enrollment to date of measured progressive disease 99.6 weeksPopulation: All participants who received at least 1 dose of study drug in Part A.
Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.
Outcome measures
| Measure |
Part A
n=38 Participants
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Part A: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate)
|
23.7 percentage of participants
Interval 12.9 to 37.7
|
—
|
SECONDARY outcome
Timeframe: Date of enrollment to date of measured progressive disease up to 18.1 weeksPopulation: All participants who received at least 1 dose of study drug in Part B.
The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated, then multiplied by 100.
Outcome measures
| Measure |
Part A
n=26 Participants
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Part B: Percentage of Participants Achieving an Overall Response (Overall Response Rate)
|
0 percentage of participants
No participants had CR or PR, therefore 90% Confidence Interval was not calculable.
|
—
|
SECONDARY outcome
Timeframe: Days 1,5 and 9 of Cycle 1 (21-day cycle)Population: All participants who received 1 dose of study drug on Days 1, 5, and 9 of Cycle 1 and had Cmax samples collected on Days 1, 5, and 9 of Cycle 1 in Part A.
Outcome measures
| Measure |
Part A
n=37 Participants
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307)
LY2523355 Day 5
|
157 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 91.4
|
—
|
|
Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307)
LY2523355 Day 9
|
100 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 420
|
—
|
|
Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307)
LY2523355 Day 1
|
146 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 69.5
|
—
|
|
Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307)
Metabolite Day 1
|
7.17 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 55.4
|
—
|
|
Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307)
Metabolite Day 5
|
6.29 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 50.8
|
—
|
|
Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307)
Metabolite Day 9
|
6.11 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 129
|
—
|
SECONDARY outcome
Timeframe: Day 3 of Cycle 1 (21-day cycle)Population: All participants who received 1 dose of study drug on Days 1, 2, and 3 of Cycle 1 and had Cmax samples collected on Day 3 of Cycle 1 in Part B.
Outcome measures
| Measure |
Part A
n=17 Participants
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
n=6 Participants
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Part B: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355
|
128 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 82
|
258 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
SECONDARY outcome
Timeframe: Days 1,5 and 9 of Cycle 1 (21-day cycle)Population: No participants were analyzed due to the very limited pharmacokinetic sampling employed in Part A that did not allow accurate calculation of the AUC(0-∞) on Days 1, 5, and 9 of Cycle 1.
Due to the very limited pharmacokinetic sampling employed in Part A of the study, the AUC(0-∞) of LY2523355 could not be accurately calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 3 of Cycle 1 (21-day cycle)Population: All participants who received 1 dose of study drug on Days 1, 2, and 3 of Cycle 1 and had pharmacokinetic samples collected on Day 3 of Cycle 1 in Part B that enabled calculation of the AUC(0-∞).
Outcome measures
| Measure |
Part A
n=17 Participants
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
n=6 Participants
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Part B: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)]
|
639 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 41
|
1220 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 38
|
SECONDARY outcome
Timeframe: Baseline and follow-up up to 104 weeks after the first dose of study drugPopulation: All participants who received at least 1 dose of study drug and had total LCSS and ASBI scores at baseline and follow-up in Part B.
LCSS is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. The LCSS total score was defined as the mean of the 9 items of the scale, with scores range from 0 (for best outcome) to 100 (for worst outcome). 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 |
Part A
n=24 Participants
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Total Lung Cancer Symptom Scale (LCSS) and Average Symptom Burden Index (ASBI)
Total LCSS at Baseline
|
28.24 units on a scale
Standard Deviation 15.2
|
—
|
|
Total Lung Cancer Symptom Scale (LCSS) and Average Symptom Burden Index (ASBI)
Total LCSS at Follow-up
|
42.61 units on a scale
Standard Deviation 14.5
|
—
|
|
Total Lung Cancer Symptom Scale (LCSS) and Average Symptom Burden Index (ASBI)
ASBI at Baseline
|
26.76 units on a scale
Standard Deviation 14.1
|
—
|
|
Total Lung Cancer Symptom Scale (LCSS) and Average Symptom Burden Index (ASBI)
ASBI at Follow-up
|
36.41 units on a scale
Standard Deviation 11.1
|
—
|
Adverse Events
Part A - 8 mg/m²/Day
Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths
Part B - 5 mg/m²/Day
Serious events: 8 serious events
Other events: 18 other events
Deaths: 0 deaths
Part B - 6 mg/m²/Day
Serious events: 8 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A - 8 mg/m²/Day
n=38 participants at risk
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 5 mg/m²/Day
n=18 participants at risk
5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
n=8 participants at risk
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.6%
1/38 • Number of events 1
|
0.00%
0/18
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.6%
1/38 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Asthenia
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Mucosal inflammation
|
0.00%
0/38
|
0.00%
0/18
|
50.0%
4/8 • Number of events 4
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
7.9%
3/38 • Number of events 3
|
0.00%
0/18
|
25.0%
2/8 • Number of events 3
|
|
Infections and infestations
Sepsis
|
2.6%
1/38 • Number of events 1
|
0.00%
0/18
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
2.6%
1/38 • Number of events 1
|
0.00%
0/18
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.6%
1/38 • Number of events 1
|
0.00%
0/18
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Headache
|
2.6%
1/38 • Number of events 1
|
0.00%
0/18
|
0.00%
0/8
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
2.6%
1/38 • Number of events 1
|
0.00%
0/18
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/38
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
2/38 • Number of events 2
|
0.00%
0/18
|
37.5%
3/8 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Stevens-johnson syndrome
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
Other adverse events
| Measure |
Part A - 8 mg/m²/Day
n=38 participants at risk
8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
|
Part B - 5 mg/m²/Day
n=18 participants at risk
5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
|
Part B - 6 mg/m²/Day
n=8 participants at risk
6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.7%
9/38 • Number of events 9
|
16.7%
3/18 • Number of events 3
|
25.0%
2/8 • Number of events 4
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.2%
5/38 • Number of events 6
|
0.00%
0/18
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.3%
2/38 • Number of events 2
|
0.00%
0/18
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Neutropenia
|
76.3%
29/38 • Number of events 74
|
61.1%
11/18 • Number of events 17
|
37.5%
3/8 • Number of events 5
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
2/38 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
2.6%
1/38 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Cardiac disorders
Tachycardia
|
2.6%
1/38 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
2.6%
1/38 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Eye disorders
Dry eye
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Eye disorders
Vision blurred
|
2.6%
1/38 • Number of events 1
|
0.00%
0/18
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
10.5%
4/38 • Number of events 4
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Constipation
|
15.8%
6/38 • Number of events 6
|
22.2%
4/18 • Number of events 6
|
37.5%
3/8 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhoea
|
18.4%
7/38 • Number of events 9
|
5.6%
1/18 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/38
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/38 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
2/38 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Nausea
|
21.1%
8/38 • Number of events 8
|
11.1%
2/18 • Number of events 2
|
37.5%
3/8 • Number of events 4
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/38
|
0.00%
0/18
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis
|
2.6%
1/38 • Number of events 1
|
22.2%
4/18 • Number of events 4
|
0.00%
0/8
|
|
Gastrointestinal disorders
Vomiting
|
7.9%
3/38 • Number of events 5
|
16.7%
3/18 • Number of events 4
|
12.5%
1/8 • Number of events 3
|
|
General disorders
Asthenia
|
0.00%
0/38
|
0.00%
0/18
|
25.0%
2/8 • Number of events 2
|
|
General disorders
Chest discomfort
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Chest pain
|
5.3%
2/38 • Number of events 2
|
5.6%
1/18 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
|
General disorders
Fatigue
|
26.3%
10/38 • Number of events 12
|
38.9%
7/18 • Number of events 9
|
50.0%
4/8 • Number of events 4
|
|
General disorders
Gait disturbance
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Mucosal inflammation
|
0.00%
0/38
|
11.1%
2/18 • Number of events 7
|
25.0%
2/8 • Number of events 3
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Oedema peripheral
|
2.6%
1/38 • Number of events 1
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/38
|
5.6%
1/18 • Number of events 2
|
0.00%
0/8
|
|
Infections and infestations
Skin infection
|
0.00%
0/38
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Infections and infestations
Urinary tract infection
|
5.3%
2/38 • Number of events 2
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Alanine aminotransferase increased
|
2.6%
1/38 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
2.6%
1/38 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Blood creatine increased
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
2.6%
1/38 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Platelet count decreased
|
2.6%
1/38 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Investigations
Weight decreased
|
0.00%
0/38
|
11.1%
2/18 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
|
Investigations
White blood cell count decreased
|
0.00%
0/38
|
16.7%
3/18 • Number of events 3
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.1%
8/38 • Number of events 8
|
22.2%
4/18 • Number of events 4
|
37.5%
3/8 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.6%
1/38 • Number of events 1
|
11.1%
2/18 • Number of events 3
|
12.5%
1/8 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.6%
1/38 • Number of events 1
|
0.00%
0/18
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/38
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.3%
2/38 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.6%
1/38 • Number of events 1
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
1/38 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
2/38 • Number of events 2
|
11.1%
2/18 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.9%
3/38 • Number of events 4
|
11.1%
2/18 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.3%
2/38 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/38
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
2/38 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
1/38 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
10.5%
4/38 • Number of events 5
|
16.7%
3/18 • Number of events 4
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.6%
1/38 • Number of events 1
|
0.00%
0/18
|
12.5%
1/8 • Number of events 2
|
|
Nervous system disorders
Neuropathy peripheral
|
5.3%
2/38 • Number of events 2
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Nervous system disorders
Presyncope
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Syncope
|
5.3%
2/38 • Number of events 3
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
5.3%
2/38 • Number of events 3
|
0.00%
0/18
|
0.00%
0/8
|
|
Psychiatric disorders
Confusional state
|
13.2%
5/38 • Number of events 5
|
0.00%
0/18
|
0.00%
0/8
|
|
Psychiatric disorders
Depression
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
10.5%
4/38 • Number of events 4
|
0.00%
0/18
|
25.0%
2/8 • Number of events 2
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 2
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.1%
8/38 • Number of events 9
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.8%
6/38 • Number of events 6
|
11.1%
2/18 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.6%
1/38 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.3%
2/38 • Number of events 2
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
1/38 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
2/38 • Number of events 2
|
0.00%
0/18
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.6%
1/38 • Number of events 1
|
0.00%
0/18
|
25.0%
2/8 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.3%
2/38 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.4%
7/38 • Number of events 8
|
0.00%
0/18
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
3/38 • Number of events 3
|
11.1%
2/18 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
0.00%
0/38
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Vascular disorders
Hypotension
|
5.3%
2/38 • Number of events 2
|
16.7%
3/18 • Number of events 3
|
25.0%
2/8 • Number of events 2
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 2
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/38
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60