Trial Outcomes & Findings for A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma (NCT NCT00490451)
NCT ID: NCT00490451
Last Updated: 2019-09-18
Results Overview
Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
First treatment dose to measured progressive disease or death from any cause up to 15.57 months
Results posted on
2019-09-18
Participant Flow
Participant milestones
| Measure |
LY573636 Target Cmax 420 µg/mL
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
LY573636 Target Cmax 360 µg/mL
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
38
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
63
|
38
|
Reasons for withdrawal
| Measure |
LY573636 Target Cmax 420 µg/mL
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
LY573636 Target Cmax 360 µg/mL
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Investigator Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Progressive Disease
|
53
|
34
|
Baseline Characteristics
A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
LY573636 Target Cmax 420 µg/mL
n=63 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
LY573636 Target Cmax 360 µg/mL
n=38 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 15.29 • n=93 Participants
|
52.6 years
STANDARD_DEVIATION 13.57 • n=4 Participants
|
53.3 years
STANDARD_DEVIATION 14.61 • n=27 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
54 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
43 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Region of Enrollment
Argentina
|
11 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
9 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully active
|
30 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Ambulatory, restricted strenuous activity
|
33 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Unknown
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: First treatment dose to measured progressive disease or death from any cause up to 15.57 monthsPopulation: All enrolled participants who received at least 1 dose of study drug.
Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Outcome measures
| Measure |
LY573636 Target Cmax 420 µg/mL
n=63 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
LY573636 Target Cmax 360 µg/mL
n=38 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
|---|---|---|
|
Progression-Free Survival
|
2.64 months
Interval 1.41 to 3.38
|
1.38 months
Interval 1.38 to 1.54
|
SECONDARY outcome
Timeframe: First treatment dose to measured progressive disease or death due to any cause up to 15.57 monthsPopulation: All enrolled participants who received at least 1 dose of study drug.
Objective response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate 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 |
LY573636 Target Cmax 420 µg/mL
n=63 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
LY573636 Target Cmax 360 µg/mL
n=38 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
|---|---|---|
|
Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)
Complete Response (CR)
|
0.0 percentage of participants
No participants had complete response (CR), therefore 90% confidence interval is not available.
|
0.0 percentage of participants
No participants had complete response (CR), therefore 90% confidence interval is not available.
|
|
Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)
Partial Response (PR)
|
3.2 percentage of participants
Interval 0.0 to 6.8
|
2.6 percentage of participants
Interval 0.0 to 6.9
|
SECONDARY outcome
Timeframe: First treatment dose to measured progressive disease or death due to any cause up to 15.57 monthsPopulation: All enrolled participants who received at least 1 dose of study drug.
Clinical Benefit Rate = (CR + PR + SD)/N as classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0), where N = total number of participants with at least one dose of study drug. CR is disappearance of all target and non-target lesions; PR is ≥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.
Outcome measures
| Measure |
LY573636 Target Cmax 420 µg/mL
n=63 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
LY573636 Target Cmax 360 µg/mL
n=38 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
|---|---|---|
|
Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)
|
46.0 percentage of participants
Interval 35.7 to 56.4
|
26.3 percentage of participants
Interval 14.6 to 38.1
|
SECONDARY outcome
Timeframe: Predose up to 2 hours postdose in Cycles 1 and 2 (21- or 28-day cycle)Population: Participants who received study drug and had pharmacokinetic (PK) data at the specified time points.
Outcome measures
| Measure |
LY573636 Target Cmax 420 µg/mL
n=62 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
LY573636 Target Cmax 360 µg/mL
n=33 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
Cycle 1
|
386.0 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 14.0
|
325.7 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 14.5
|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
Cycle 2
|
346.5 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 15.0
|
351.8 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 12.8
|
SECONDARY outcome
Timeframe: First treatment dose to death due to any cause up to 26.51 monthsPopulation: All enrolled participants who received at least 1 dose of study drug.
Defined as the time from date of first dose to the date of death due to any cause.
Outcome measures
| Measure |
LY573636 Target Cmax 420 µg/mL
n=63 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
LY573636 Target Cmax 360 µg/mL
n=38 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
|---|---|---|
|
Overall Survival Time
|
8.71 months
Interval 7.39 to 16.23
|
12.25 months
Interval 7.79 to 15.64
|
SECONDARY outcome
Timeframe: Time of response to progressive disease or death up to 15.57 monthsPopulation: Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression of disease or death due to any cause. CR or PR is classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from documented SD or better to first date of progressive disease up to 15.57 monthsPopulation: All enrolled participants who received at least 1 dose of study drug and had a best overall response of stable disease or better.
Duration of SD is defined from date of documented SD or better to first date of progression of disease (PD) (assessed every other cycle during study therapy, or every 2 months during post-therapy until PD). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Outcome measures
| Measure |
LY573636 Target Cmax 420 µg/mL
n=29 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
LY573636 Target Cmax 360 µg/mL
n=10 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
|---|---|---|
|
Duration of Stable Disease (SD)
|
4.44 months
Interval 4.14 to 5.42
|
5.91 months
Interval 2.76 to 7.89
|
SECONDARY outcome
Timeframe: First treatment dose up to 26.51 monthsPopulation: All enrolled participants who received at least 1 dose of study drug.
Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.
Outcome measures
| Measure |
LY573636 Target Cmax 420 µg/mL
n=63 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
LY573636 Target Cmax 360 µg/mL
n=38 Participants
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
|---|---|---|
|
Number of Participants With Adverse Events (Safety)
Serious Adverse Events
|
23 Participants
|
10 Participants
|
|
Number of Participants With Adverse Events (Safety)
Other Nonserious Adverse Events
|
59 Participants
|
36 Participants
|
Adverse Events
LY573636 Target Cmax 420 µg/mL
Serious events: 23 serious events
Other events: 59 other events
Deaths: 0 deaths
LY573636 Target Cmax 360 µg/mL
Serious events: 10 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY573636 Target Cmax 420 µg/mL
n=63 participants at risk
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
LY573636 Target Cmax 360 µg/mL
n=38 participants at risk
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
|---|---|---|
|
Gastrointestinal disorders
Oesophageal fistula
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/63
|
2.6%
1/38 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
2/63 • Number of events 2
|
5.3%
2/38 • Number of events 2
|
|
General disorders
Fatigue
|
0.00%
0/63
|
2.6%
1/38 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
3.2%
2/63 • Number of events 2
|
0.00%
0/38
|
|
General disorders
Multi-organ failure
|
0.00%
0/63
|
2.6%
1/38 • Number of events 1
|
|
General disorders
Pyrexia
|
1.6%
1/63 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/63
|
2.6%
1/38 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/63
|
2.6%
1/38 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/63
|
2.6%
1/38 • Number of events 1
|
|
Infections and infestations
Neutropenic sepsis
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Infections and infestations
Pneumonia
|
4.8%
3/63 • Number of events 3
|
0.00%
0/38
|
|
Infections and infestations
Septic shock
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Injury, poisoning and procedural complications
Drug exposure during pregnancy
|
0.00%
0/63
|
2.6%
1/38 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
3/63 • Number of events 3
|
0.00%
0/38
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
1/63 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Nervous system disorders
Spinal cord compression
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/63
|
2.6%
1/38 • Number of events 1
|
|
Psychiatric disorders
Anxiety disorder
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Renal and urinary disorders
Urinary retention
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/63
|
5.3%
2/38 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
2/63 • Number of events 2
|
0.00%
0/38
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.6%
1/63 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.6%
1/63 • Number of events 2
|
0.00%
0/38
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Blood and lymphatic system disorders
Anaemia
|
9.5%
6/63 • Number of events 6
|
7.9%
3/38 • Number of events 4
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.3%
4/63 • Number of events 4
|
2.6%
1/38 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/63
|
5.3%
2/38 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.3%
4/63 • Number of events 4
|
2.6%
1/38 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.5%
6/63 • Number of events 7
|
10.5%
4/38 • Number of events 5
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/63
|
2.6%
1/38 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
3.2%
2/63 • Number of events 2
|
0.00%
0/38
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/63
|
2.6%
1/38 • Number of events 1
|
|
Gastrointestinal disorders
Anal inflammation
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/63
|
2.6%
1/38 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/63
|
2.6%
1/38 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/63
|
2.6%
1/38 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/63
|
2.6%
1/38 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/63
|
2.6%
1/38 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/63 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.2%
2/63 • Number of events 2
|
2.6%
1/38 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Surgical and medical procedures
Leg amputation
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Surgical and medical procedures
Surgery
|
1.6%
1/63 • Number of events 1
|
0.00%
0/38
|
|
Vascular disorders
Hypotension
|
1.6%
1/63 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
Other adverse events
| Measure |
LY573636 Target Cmax 420 µg/mL
n=63 participants at risk
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
LY573636 Target Cmax 360 µg/mL
n=38 participants at risk
LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
30.2%
19/63 • Number of events 27
|
15.8%
6/38 • Number of events 11
|
|
Blood and lymphatic system disorders
Leukopenia
|
31.7%
20/63 • Number of events 26
|
5.3%
2/38 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphopenia
|
22.2%
14/63 • Number of events 15
|
5.3%
2/38 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.8%
15/63 • Number of events 27
|
10.5%
4/38 • Number of events 5
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
21/63 • Number of events 37
|
21.1%
8/38 • Number of events 15
|
|
Cardiac disorders
Palpitations
|
4.8%
3/63 • Number of events 3
|
5.3%
2/38 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
4.8%
3/63 • Number of events 3
|
10.5%
4/38 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/63
|
5.3%
2/38 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
15.9%
10/63 • Number of events 12
|
13.2%
5/38 • Number of events 6
|
|
Gastrointestinal disorders
Constipation
|
27.0%
17/63 • Number of events 17
|
15.8%
6/38 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhoea
|
27.0%
17/63 • Number of events 22
|
18.4%
7/38 • Number of events 7
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
3/63 • Number of events 3
|
5.3%
2/38 • Number of events 2
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.3%
4/63 • Number of events 4
|
0.00%
0/38
|
|
Gastrointestinal disorders
Nausea
|
17.5%
11/63 • Number of events 12
|
18.4%
7/38 • Number of events 7
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/63
|
5.3%
2/38 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis
|
9.5%
6/63 • Number of events 11
|
2.6%
1/38 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
7.9%
5/63 • Number of events 6
|
10.5%
4/38 • Number of events 5
|
|
General disorders
Asthenia
|
6.3%
4/63 • Number of events 5
|
7.9%
3/38 • Number of events 3
|
|
General disorders
Chest discomfort
|
3.2%
2/63 • Number of events 2
|
5.3%
2/38 • Number of events 2
|
|
General disorders
Fatigue
|
39.7%
25/63 • Number of events 27
|
23.7%
9/38 • Number of events 9
|
|
General disorders
Influenza like illness
|
0.00%
0/63
|
5.3%
2/38 • Number of events 2
|
|
General disorders
Injection site pain
|
3.2%
2/63 • Number of events 3
|
5.3%
2/38 • Number of events 2
|
|
General disorders
Mucosal inflammation
|
7.9%
5/63 • Number of events 5
|
10.5%
4/38 • Number of events 4
|
|
General disorders
Oedema peripheral
|
19.0%
12/63 • Number of events 12
|
10.5%
4/38 • Number of events 4
|
|
General disorders
Pain
|
1.6%
1/63 • Number of events 1
|
7.9%
3/38 • Number of events 3
|
|
General disorders
Pyrexia
|
11.1%
7/63 • Number of events 7
|
7.9%
3/38 • Number of events 3
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.9%
5/63 • Number of events 5
|
0.00%
0/38
|
|
Infections and infestations
Sepsis
|
0.00%
0/63
|
5.3%
2/38 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
2/63 • Number of events 2
|
5.3%
2/38 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
3.2%
2/63 • Number of events 2
|
5.3%
2/38 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
7.9%
5/63 • Number of events 5
|
2.6%
1/38 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
7.9%
5/63 • Number of events 5
|
2.6%
1/38 • Number of events 1
|
|
Investigations
Weight decreased
|
12.7%
8/63 • Number of events 8
|
7.9%
3/38 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
7.9%
5/63 • Number of events 5
|
5.3%
2/38 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.8%
3/63 • Number of events 3
|
7.9%
3/38 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
6.3%
4/63 • Number of events 5
|
2.6%
1/38 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.1%
7/63 • Number of events 9
|
2.6%
1/38 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
17.5%
11/63 • Number of events 13
|
2.6%
1/38 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
23.8%
15/63 • Number of events 23
|
15.8%
6/38 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.9%
5/63 • Number of events 6
|
0.00%
0/38
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.1%
7/63 • Number of events 10
|
2.6%
1/38 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
3/63 • Number of events 3
|
13.2%
5/38 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.9%
10/63 • Number of events 11
|
7.9%
3/38 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.2%
2/63 • Number of events 2
|
5.3%
2/38 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.6%
1/63 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.5%
6/63 • Number of events 8
|
5.3%
2/38 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.6%
1/63 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
7.9%
5/63 • Number of events 5
|
0.00%
0/38
|
|
Nervous system disorders
Dysgeusia
|
4.8%
3/63 • Number of events 3
|
10.5%
4/38 • Number of events 4
|
|
Nervous system disorders
Headache
|
7.9%
5/63 • Number of events 5
|
5.3%
2/38 • Number of events 2
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/63
|
5.3%
2/38 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
1.6%
1/63 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.5%
6/63 • Number of events 6
|
5.3%
2/38 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
9.5%
6/63 • Number of events 6
|
0.00%
0/38
|
|
Psychiatric disorders
Insomnia
|
12.7%
8/63 • Number of events 8
|
5.3%
2/38 • Number of events 2
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/63
|
5.3%
2/38 • Number of events 2
|
|
Renal and urinary disorders
Pollakiuria
|
1.6%
1/63 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
3.2%
2/63 • Number of events 2
|
5.3%
2/38 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.7%
8/63 • Number of events 9
|
7.9%
3/38 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.5%
11/63 • Number of events 11
|
18.4%
7/38 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.7%
8/63 • Number of events 8
|
2.6%
1/38 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.3%
4/63 • Number of events 4
|
0.00%
0/38
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/63
|
5.3%
2/38 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.0%
12/63 • Number of events 12
|
0.00%
0/38
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.3%
4/63 • Number of events 5
|
0.00%
0/38
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.9%
5/63 • Number of events 6
|
5.3%
2/38 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/63
|
5.3%
2/38 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.3%
4/63 • Number of events 4
|
5.3%
2/38 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.3%
4/63 • Number of events 5
|
0.00%
0/38
|
|
Vascular disorders
Hypotension
|
4.8%
3/63 • Number of events 3
|
7.9%
3/38 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60