Trial Outcomes & Findings for A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck (NCT NCT01059643)
NCT ID: NCT01059643
Last Updated: 2019-09-18
Results Overview
The percentage of participants who achieved a best response of either CR or PR, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Percentage is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
Baseline until progressive disease up to 36 weeks post-baseline
Results posted on
2019-09-18
Participant Flow
All participants who received at least one dose of study drug in both Cycle 1 and Cycle 2 or to have progressed or died on or before study Day 42 were considered to be completed.
Participant milestones
| Measure |
LY2523355
LY2523355: Dose determined by participant's body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a 1-hour infusion on Days 1, 2 and 3 of a 21-day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
|
|---|---|
|
Overall Study
STARTED
|
103
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
103
|
|
Overall Study
COMPLETED
|
97
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
LY2523355
LY2523355: Dose determined by participant's body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a 1-hour infusion on Days 1, 2 and 3 of a 21-day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck
Baseline characteristics by cohort
| Measure |
LY2523355
n=103 Participants
LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
|
|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 10.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
103 Participants
n=5 Participants
|
|
Tumor Type
Colorectal Cancer
|
17 participants
n=5 Participants
|
|
Tumor Type
Gastroesophageal Cancer
|
13 participants
n=5 Participants
|
|
Tumor Type
Non-Small Cell Lung Cancer
|
29 participants
n=5 Participants
|
|
Tumor Type
Ovarian Cancer
|
13 participants
n=5 Participants
|
|
Tumor Type
Prostate Cancer
|
18 participants
n=5 Participants
|
|
Tumor Type
Squamous Cell Carcinoma of the Head and Neck
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline until progressive disease up to 36 weeks post-baselinePopulation: All enrolled participants who received at least 1 dose of study drug.
The percentage of participants who achieved a best response of either CR or PR, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Percentage is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Outcome measures
| Measure |
LY2523355
n=103 Participants
LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
|
6 mg/m² LY253355
LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
Colorectal Cancer
|
0 percentage of participants
Interval 0.0 to 17.1
|
—
|
|
Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
Gastroesophageal Cancer
|
0 percentage of participants
Interval 0.0 to 22.1
|
—
|
|
Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
Non-Small Cell Lung Cancer
|
0 percentage of participants
Interval 0.0 to 10.9
|
—
|
|
Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
Ovarian Cancer
|
0 percentage of participants
Interval 0.0 to 20.6
|
—
|
|
Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
Prostate Cancer
|
0 percentage of participants
Interval 0.0 to 16.2
|
—
|
|
Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
Squamous Cell Carcinoma of Head and Neck
|
0 percentage of participants
Interval 0.0 to 25.9
|
—
|
SECONDARY outcome
Timeframe: Date of enrollment to progressive disease or death due to any cause up to 36 weeks post-enrollmentPopulation: All enrolled participants who received at least 1 dose of study drug. Percentage (%) of participants censored were colorectal cancer 5.9%; gastroesophageal cancer 0.0%, non-small cell lung cancer 3.4%, ovarian cancer 15.4%, prostate cancer 16.7%, and squamous cell carcinoma of the head and neck 15.4%.
PFS defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 millimeter (mm) increase over nadir. For participants who were not known to have died or to have progressed as of the data inclusion cutoff date, PFS were censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.
Outcome measures
| Measure |
LY2523355
n=103 Participants
LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
|
6 mg/m² LY253355
LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Progression Free Survival (PFS)
Colorectal Cancer
|
1.30 months
Interval 1.28 to 2.69
|
—
|
|
Progression Free Survival (PFS)
Gastroesophageal Cancer
|
1.25 months
Interval 0.62 to 1.51
|
—
|
|
Progression Free Survival (PFS)
Non-Small Cell Lung Cancer
|
1.31 months
Interval 1.28 to 1.91
|
—
|
|
Progression Free Survival (PFS)
Ovarian Cancer
|
1.31 months
Interval 1.18 to 2.1
|
—
|
|
Progression Free Survival (PFS)
Prostate Cancer
|
2.30 months
Interval 1.45 to 2.66
|
—
|
|
Progression Free Survival (PFS)
Squamous Cell Carcinoma of Head and Neck
|
1.51 months
Interval 0.72 to 2.76
|
—
|
SECONDARY outcome
Timeframe: Baseline until progressive disease up to 36 weeks post-baselinePopulation: All enrolled participants who received at least 1 dose of study drug.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.
Outcome measures
| Measure |
LY2523355
n=103 Participants
LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
|
6 mg/m² LY253355
LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Colorectal Cancer
|
37.5 percentage of participants
Interval 17.8 to 60.9
|
—
|
|
Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Gastroesophageal Cancer
|
16.7 percentage of participants
Interval 3.0 to 43.8
|
—
|
|
Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Non-Small Cell Lung Cancer
|
38.5 percentage of participants
Interval 22.6 to 56.4
|
—
|
|
Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Ovarian Cancer
|
30.8 percentage of participants
Interval 11.3 to 57.3
|
—
|
|
Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Prostate Cancer
|
47.1 percentage of participants
Interval 26.0 to 68.9
|
—
|
|
Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Squamous Cell Carcinoma of Head and Neck
|
50.0 percentage of participants
Interval 22.2 to 77.8
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants who received at least 1 dose of study drug.
The number of participants with colorectal cancer (CRC), gastroesophageal cancer (GE), non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer or squamous cell carcinoma of head and neck (SCCHN) who had marker/molecular diagnostics performed prior to study entry to determine the mutation status of cancer genes: APC, BRAF, BRCA1, BRCA2, HRAS and KRAS and the presence of Human Papillovirus (HPV) and Epstein Barr viruses (EBV). Mutation/virus status was defined as: positive (mutation/virus present), negative (mutation/virus not present), unknown (mutation/virus status unknown), or not done (mutation/virus status was not done).
Outcome measures
| Measure |
LY2523355
n=103 Participants
LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
|
6 mg/m² LY253355
LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
CRC-BRAF Mutation, Negative
|
2 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
CRC-BRAF Mutation, Not Done/Unknown
|
15 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
CRC-KRAS Mutation, Positive
|
9 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
CRC-KRAS Mutation, Negative
|
7 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
CRC-KRAS Mutation, Not Done
|
1 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
GE-KRAS Mutation, Negative
|
1 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
GE-KRAS Mutation, Not Done/Unknown
|
12 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
NSCLC-KRAS Mutation, Positive
|
3 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
NSCLC-KRAS Mutation, Negative
|
5 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
NSCLC-KRAS Mutation, Not Done/Unknown
|
21 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
Ovarian-BRCA1 Mutation, Negative
|
3 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
Ovarian-BRCA1 Mutation, Not Done/Unknown
|
10 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
Ovarian-BRCA2 Mutation, Negative
|
3 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
Ovarian-BRCA2 Mutation, Not Done/Unknown
|
10 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
SCCHN-APC Mutation, Negative
|
1 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
SCCHN-APC Mutation, Not Done/Unknown
|
12 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
SCCHN-HPV (HPV-31 Positive) Mutation
|
1 Participants
|
—
|
|
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
SCCHN-HPV Mutation, Not Done/Unknown
|
12 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline until cycle with maximum change from baseline up to 36 weeksPopulation: All enrolled participants who received at least 1 dose of study drug with results at baseline and at time of best response.
The percent change in tumor size at its smallest size. The sum of diameters of target lesions was determined at each tumor assessment. The percent change is the smallest post-baseline sum divided by the baseline (pre-treatment) sum, multiplied by 100.
Outcome measures
| Measure |
LY2523355
n=73 Participants
LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
|
6 mg/m² LY253355
LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Change in Tumor Size at Smallest Size (Best Response)
Colorectal Cancer
|
15.4 percentage of change
Standard Deviation 17.12
|
—
|
|
Change in Tumor Size at Smallest Size (Best Response)
Gastroesophageal Cancer
|
29.0 percentage of change
Standard Deviation 70.00
|
—
|
|
Change in Tumor Size at Smallest Size (Best Response)
Non-Small Cell Lung Cancer
|
21.9 percentage of change
Standard Deviation 48.69
|
—
|
|
Change in Tumor Size at Smallest Size (Best Response)
Ovarian Cancer
|
22.1 percentage of change
Standard Deviation 31.40
|
—
|
|
Change in Tumor Size at Smallest Size (Best Response)
Prostate Cancer
|
12.2 percentage of change
Standard Deviation 15.91
|
—
|
|
Change in Tumor Size at Smallest Size (Best Response)
Squamous Cell Carcinoma of Head and Neck
|
3.9 percentage of change
Standard Deviation 30.67
|
—
|
SECONDARY outcome
Timeframe: Day 3 of Cycle 1 (21-day cycle)Population: All enrolled participants who received at least 1 dose of study drug with Cmax measure.
Plasma Cmax following daily doses of LY2523355 on Days 1, 2, and 3 of Cycle 1 (21-day cycle).
Outcome measures
| Measure |
LY2523355
n=65 Participants
LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
|
6 mg/m² LY253355
n=31 Participants
LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307
LY2523355
|
125 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 79
|
124 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 67
|
|
Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307
LSN2546307
|
5.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
5.3 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 52
|
SECONDARY outcome
Timeframe: Day 1 and Day 3 of Cycle 1 (21-day cycle)Population: All enrolled participants who received at least 1 dose of study drug with Ra measure.
Intracycle Ra of LY2523355 is the ratio of LY2523355 maximum plasma concentration (Cmax) on Day 3 of Cycle 1 to the Cmax of LY2523355 on Day 1 of Cycle 1 following daily doses of LY2523355 on Days 1, 2 and 3 of Cycle 1 (21-day cycle) at each dose level.
Outcome measures
| Measure |
LY2523355
n=65 Participants
LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
|
6 mg/m² LY253355
n=28 Participants
LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Pharmacokinetics, Intracycle Accumulation Ratio (Ra) of LY2523355
|
1.02 ratio
Geometric Coefficient of Variation 87
|
1.08 ratio
Geometric Coefficient of Variation 61
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of study treatment up to 30-days post-study treatment discontinuationPopulation: All enrolled participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
LY2523355
n=103 Participants
LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
|
6 mg/m² LY253355
LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
|
|---|---|---|
|
Number of Participants Who Died Due to Unknown Causes During the 30-Day Post-Study Treatment Follow-Up
|
5 Participants
|
—
|
Adverse Events
LY2523355
Serious events: 39 serious events
Other events: 102 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2523355
n=103 participants at risk
LY2523355: Dose determined by participant's body surface area: 5 milligrams/meter squared (mg/m²) or 6 mg/m², administered intravenously on days 1, 2, 3 of a 21 day cycle; for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously 24 hours after third dose of LY2523355 on day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
3/103 • Number of events 3
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.8%
6/103 • Number of events 6
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Cardiac disorders
Pericardial effusion
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Anal fistula
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Ascites
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
2/103 • Number of events 2
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Dysphagia
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Nausea
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Stomatitis
|
2.9%
3/103 • Number of events 3
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
3/103 • Number of events 3
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
General disorders
Death
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
General disorders
Fatigue
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
General disorders
Mucosal inflammation
|
4.9%
5/103 • Number of events 6
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
General disorders
Non-cardiac chest pain
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
General disorders
Pyrexia
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Infections and infestations
Cellulitis
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Infections and infestations
Clostridium difficile colitis
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Infections and infestations
Diverticulitis
|
1.9%
2/103 • Number of events 2
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Infections and infestations
Gastroenteritis
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Infections and infestations
Neutropenic sepsis
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Infections and infestations
Oral herpes
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Infections and infestations
Pneumonia
|
6.8%
7/103 • Number of events 7
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Infections and infestations
Rectal abscess
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Infections and infestations
Sepsis
|
3.9%
4/103 • Number of events 4
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Infections and infestations
Staphylococcal sepsis
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Infections and infestations
Urinary tract infection
|
1.9%
2/103 • Number of events 2
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Investigations
Blood creatinine increased
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Investigations
Lymphocyte count decreased
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Investigations
Neutrophil count decreased
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Investigations
White blood cell count decreased
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
5/103 • Number of events 5
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
2/103 • Number of events 2
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
2/103 • Number of events 2
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Nervous system disorders
Ischaemic stroke
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Psychiatric disorders
Completed suicide
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Psychiatric disorders
Mental status changes
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Renal and urinary disorders
Haematuria
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Renal and urinary disorders
Urinary retention
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.9%
4/103 • Number of events 4
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.9%
3/103 • Number of events 3
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Vascular disorders
Deep vein thrombosis
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Vascular disorders
Jugular vein thrombosis
|
0.97%
1/103 • Number of events 1
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
Other adverse events
| Measure |
LY2523355
n=103 participants at risk
LY2523355: Dose determined by participant's body surface area: 5 milligrams/meter squared (mg/m²) or 6 mg/m², administered intravenously on days 1, 2, 3 of a 21 day cycle; for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously 24 hours after third dose of LY2523355 on day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
32.0%
33/103 • Number of events 52
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.4%
21/103 • Number of events 21
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.6%
13/103 • Number of events 18
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Abdominal pain
|
10.7%
11/103 • Number of events 12
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Constipation
|
23.3%
24/103 • Number of events 25
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Diarrhoea
|
17.5%
18/103 • Number of events 22
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Dysphagia
|
5.8%
6/103 • Number of events 6
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Nausea
|
34.0%
35/103 • Number of events 38
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Oral pain
|
6.8%
7/103 • Number of events 7
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Stomatitis
|
13.6%
14/103 • Number of events 15
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Gastrointestinal disorders
Vomiting
|
17.5%
18/103 • Number of events 19
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
General disorders
Asthenia
|
5.8%
6/103 • Number of events 7
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
General disorders
Fatigue
|
43.7%
45/103 • Number of events 54
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
General disorders
Mucosal inflammation
|
18.4%
19/103 • Number of events 22
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
General disorders
Oedema peripheral
|
9.7%
10/103 • Number of events 13
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
General disorders
Pyrexia
|
8.7%
9/103 • Number of events 11
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Infections and infestations
Urinary tract infection
|
5.8%
6/103 • Number of events 6
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Investigations
Blood alkaline phosphatase increased
|
7.8%
8/103 • Number of events 8
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Investigations
Blood creatinine increased
|
6.8%
7/103 • Number of events 7
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Investigations
Weight decreased
|
9.7%
10/103 • Number of events 10
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Investigations
White blood cell count decreased
|
5.8%
6/103 • Number of events 7
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.2%
26/103 • Number of events 29
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Metabolism and nutrition disorders
Dehydration
|
6.8%
7/103 • Number of events 7
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.8%
6/103 • Number of events 9
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.7%
10/103 • Number of events 10
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.8%
7/103 • Number of events 7
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
9/103 • Number of events 10
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.5%
18/103 • Number of events 20
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.6%
13/103 • Number of events 13
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.8%
8/103 • Number of events 8
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Nervous system disorders
Dizziness
|
6.8%
7/103 • Number of events 7
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Nervous system disorders
Headache
|
9.7%
10/103 • Number of events 10
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Psychiatric disorders
Anxiety
|
6.8%
7/103 • Number of events 8
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Psychiatric disorders
Insomnia
|
12.6%
13/103 • Number of events 13
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
9/103 • Number of events 9
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.6%
15/103 • Number of events 20
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.7%
12/103 • Number of events 12
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
|
Vascular disorders
Hypotension
|
6.8%
7/103 • Number of events 7
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
|
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