Trial Outcomes & Findings for A Dose-Finding Study of E7389 in Combination With Carboplatin in Patients With Solid Tumors (NCT NCT00268905)
NCT ID: NCT00268905
Last Updated: 2013-02-12
Results Overview
MTD was established by summarizing the number and percent of subject with dose- limiting toxicities (DLTs) for the first cycle.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
21 days (first cycle)
Results posted on
2013-02-12
Participant Flow
Participant milestones
| Measure |
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5
Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
|
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6
Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
|
Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6
Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
9
|
12
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
43
|
9
|
12
|
Reasons for withdrawal
| Measure |
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5
Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
|
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6
Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
|
Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6
Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
3
|
|
Overall Study
Progressive Disease
|
28
|
4
|
3
|
|
Overall Study
Physician Decision
|
3
|
0
|
1
|
|
Overall Study
Clinical Progression
|
9
|
4
|
1
|
Baseline Characteristics
A Dose-Finding Study of E7389 in Combination With Carboplatin in Patients With Solid Tumors
Baseline characteristics by cohort
| Measure |
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5
n=43 Participants
Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
|
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6
n=9 Participants
Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
|
Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6
n=12 Participants
Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
59.2 years
STANDARD_DEVIATION 8.35 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 8.08 • n=7 Participants
|
64.4 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 8.75 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 21 days (first cycle)MTD was established by summarizing the number and percent of subject with dose- limiting toxicities (DLTs) for the first cycle.
Outcome measures
| Measure |
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5
n=43 Participants
Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
|
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6
n=9 Participants
Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
|
Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6
n=12 Participants
Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Eribulin Mesylate of E7389 in Combination With Carboplatin in Subjects With Advanced Solid Tumors.
|
1.4 mg/m^2
|
1.1 mg/m^2
|
1.1 mg/m^2
|
SECONDARY outcome
Timeframe: Throughout the entire studyPopulation: Safety Evaluable Population
Adverse events were considered treatment emergent if they started on or after the date of administration of the first dose of study drug, or if they were present prior to the administration of the first dose of study drug and increased in severity during the study.
Outcome measures
| Measure |
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5
n=43 Participants
Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
|
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6
n=9 Participants
Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
|
Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6
n=12 Participants
Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
|
|---|---|---|---|
|
Safety of Eribulin Mesylate in Combination With Carboplatin as Measured by the Number of Subjects With Treatment Emergent Adverse Events.
|
42 participants
|
9 participants
|
12 participants
|
SECONDARY outcome
Timeframe: From start of eribulin treatment until disease progression or deathPopulation: Efficacy Evaluable Population
Objective response measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria and is Complete Response (disappearance of all target lesions) plus Partial Response (at least 30% decrease in sum of longest diameter \[LD\] of target lesions compared baseline sum of LD).
Outcome measures
| Measure |
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5
n=43 Participants
Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
|
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6
n=9 Participants
Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
|
Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6
n=11 Participants
Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
|
|---|---|---|---|
|
Percent of Subjects With Best Overall Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.
Best Overall Response Rate
|
7 percentage of subjects
|
11.1 percentage of subjects
|
27.3 percentage of subjects
|
|
Percent of Subjects With Best Overall Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.
Complete Response
|
2.3 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Percent of Subjects With Best Overall Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.
Partial Response
|
4.7 percentage of subjects
|
11.1 percentage of subjects
|
27.3 percentage of subjects
|
|
Percent of Subjects With Best Overall Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.
Stable Disease
|
48.8 percentage of subjects
|
33.3 percentage of subjects
|
36.4 percentage of subjects
|
|
Percent of Subjects With Best Overall Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.
Progressive Disease
|
32.6 percentage of subjects
|
22.2 percentage of subjects
|
9.1 percentage of subjects
|
|
Percent of Subjects With Best Overall Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.
Not Evaluable
|
11.6 percentage of subjects
|
33.3 percentage of subjects
|
27.3 percentage of subjects
|
Adverse Events
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5
Serious events: 18 serious events
Other events: 42 other events
Deaths: 0 deaths
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5
n=43 participants at risk
Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
|
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6
n=9 participants at risk
Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
|
Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6
n=12 participants at risk
Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
1/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.3%
1/43
|
22.2%
2/9
|
25.0%
3/12
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.3%
1/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/43
|
0.00%
0/9
|
16.7%
2/12
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/43
|
0.00%
0/9
|
25.0%
3/12
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.3%
1/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diarrhea
|
4.7%
2/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
General disorders
Asthenia
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
General disorders
Non-Cardiac Chest Pain
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
General disorders
Pain
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
General disorders
Pyrexia
|
2.3%
1/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Infections and infestations
Infection
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Infections and infestations
Urosepsis
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Infections and infestations
Pneumonia
|
0.00%
0/43
|
0.00%
0/9
|
16.7%
2/12
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Oral Intake Reduced
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Nervous system disorders
Cerebral Hemorrhage
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Nervous system disorders
Sensorimotor Disorder
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Nervous system disorders
Spinal Cord Compression
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Nervous system disorders
Syncope
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Nervous system disorders
Syringomyelia
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Nervous system disorders
Cerebral Ischemia
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.3%
1/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Renal and urinary disorders
Renal Vein Thrombosis
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
1/43
|
11.1%
1/9
|
16.7%
2/12
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.3%
1/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.3%
1/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Vascular disorders
Deep Vein Thrombosis
|
2.3%
1/43
|
22.2%
2/9
|
8.3%
1/12
|
Other adverse events
| Measure |
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5
n=43 participants at risk
Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
|
Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6
n=9 participants at risk
Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
|
Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6
n=12 participants at risk
Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
|
|---|---|---|---|
|
Ear and labyrinth disorders
Anemia
|
34.9%
15/43
|
22.2%
2/9
|
58.3%
7/12
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.3%
4/43
|
0.00%
0/9
|
25.0%
3/12
|
|
Blood and lymphatic system disorders
Neutropenia
|
51.2%
22/43
|
66.7%
6/9
|
66.7%
8/12
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
37.2%
16/43
|
22.2%
2/9
|
66.7%
8/12
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/43
|
22.2%
2/9
|
33.3%
4/12
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Gastrointestinal disorders
Abdominal Distention
|
7.0%
3/43
|
77.8%
7/9
|
16.7%
2/12
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.9%
9/43
|
11.1%
1/9
|
8.3%
1/12
|
|
Gastrointestinal disorders
Constipation
|
23.3%
10/43
|
44.4%
4/9
|
33.3%
4/12
|
|
General disorders
Diarrhea
|
25.6%
11/43
|
11.1%
1/9
|
33.3%
4/12
|
|
Gastrointestinal disorders
Nausea
|
39.5%
17/43
|
44.4%
4/9
|
25.0%
3/12
|
|
Gastrointestinal disorders
Vomiting
|
23.3%
10/43
|
55.6%
5/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/43
|
22.2%
2/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Gastrointestinal disorders
GI Reflux Disease
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Gastrointestinal disorders
Tooth Loss
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Gastrointestinal disorders
Hemorrhoidal Hemorrhage
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
General disorders
Fatigue
|
53.5%
23/43
|
77.8%
7/9
|
66.7%
8/12
|
|
Hepatobiliary disorders
Performance Status Decreased
|
14.0%
6/43
|
22.2%
2/9
|
0.00%
0/12
|
|
General disorders
Catheter Site Pain
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
General disorders
Gait Disturbance
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
General disorders
Edema Peripheral
|
0.00%
0/43
|
11.1%
1/9
|
16.7%
2/12
|
|
General disorders
Asthenia
|
0.00%
0/43
|
11.1%
1/9
|
8.3%
1/12
|
|
General disorders
Axillary Pain
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
General disorders
Chills
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Hepatobiliary disorders
Extravasation
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
General disorders
Pain
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
General disorders
Pyrexia
|
0.00%
0/43
|
0.00%
0/9
|
41.7%
5/12
|
|
Infections and infestations
Urinary Tract Infection
|
7.0%
3/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Infections and infestations
Infusion Site Infection
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Infections and infestations
Localised Infection
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/43
|
11.1%
1/9
|
8.3%
1/12
|
|
Infections and infestations
Candidiasis
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Infections and infestations
Infection
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Nervous system disorders
Pneumonia
|
0.00%
0/43
|
0.00%
0/9
|
16.7%
2/12
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Femural Neck Fracture
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Blood Lactate Dehydrogenase Increased
|
7.0%
3/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Investigations
Weight Decreased
|
14.0%
6/43
|
11.1%
1/9
|
25.0%
3/12
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Investigations
Breath Sounds Abnormal
|
0.00%
0/43
|
22.2%
2/9
|
0.00%
0/12
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Investigations
Hemoglobin Decreased
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Anorexia
|
23.3%
10/43
|
55.6%
5/9
|
25.0%
3/12
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.3%
4/43
|
0.00%
0/9
|
25.0%
3/12
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.0%
3/43
|
22.2%
2/9
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/43
|
11.1%
1/9
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/43
|
11.1%
1/9
|
33.3%
4/12
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Oral Intake Reduced
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.6%
5/43
|
44.4%
4/9
|
16.7%
2/12
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
7.0%
3/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
7.0%
3/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
7.0%
3/43
|
11.1%
1/9
|
8.3%
1/12
|
|
Nervous system disorders
Myalgia
|
9.3%
4/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
9.3%
4/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
11.6%
5/43
|
11.1%
1/9
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/43
|
11.1%
1/9
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/43
|
0.00%
0/9
|
16.7%
2/12
|
|
Nervous system disorders
Dizziness
|
14.0%
6/43
|
0.00%
0/9
|
16.7%
2/12
|
|
Nervous system disorders
Dysgeusia
|
7.0%
3/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Nervous system disorders
Headache
|
14.0%
6/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Nervous system disorders
Hypoaesthesia
|
7.0%
3/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Nervous system disorders
Neuropathy Peripheral
|
9.3%
4/43
|
0.00%
0/9
|
16.7%
2/12
|
|
Nervous system disorders
Ageusia
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Pregnancy, puerperium and perinatal conditions
Amnesia
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Nervous system disorders
Areflexia
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Nervous system disorders
Insomnia
|
0.00%
0/43
|
11.1%
1/9
|
8.3%
1/12
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Pregnancy, puerperium and perinatal conditions
Restless Leg Syndrome
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Nervous system disorders
Cerebral Ischemia
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Renal and urinary disorders
Dysuria
|
7.0%
3/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
4/43
|
0.00%
0/9
|
41.7%
5/12
|
|
Skin and subcutaneous tissue disorders
Dyspnea
|
16.3%
7/43
|
33.3%
3/9
|
41.7%
5/12
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/43
|
11.1%
1/9
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/43
|
11.1%
1/9
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Dysphonia
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea Exertional
|
0.00%
0/43
|
0.00%
0/9
|
16.7%
2/12
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/43
|
0.00%
0/9
|
16.7%
2/12
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/43
|
0.00%
0/9
|
16.7%
2/12
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.3%
7/43
|
22.2%
2/9
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.0%
3/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.3%
4/43
|
0.00%
0/9
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Facial Wasting
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Pain in Skin
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Rash Poplar
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/43
|
22.2%
2/9
|
8.3%
1/12
|
|
Vascular disorders
Hematoma
|
0.00%
0/43
|
11.1%
1/9
|
0.00%
0/12
|
|
Vascular disorders
Hypotension
|
0.00%
0/43
|
11.1%
1/9
|
16.7%
2/12
|
|
Vascular disorders
Flushing
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
|
Vascular disorders
Phlebitis
|
0.00%
0/43
|
0.00%
0/9
|
8.3%
1/12
|
Additional Information
Prash Krishna, Study Director
Eisai
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place