Trial Outcomes & Findings for Study of E7389 for Advanced or Metastatic Breast Cancer (NCT NCT00965523)
NCT ID: NCT00965523
Last Updated: 2013-08-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Every week during treatment and up to 30 days after last dose of study treatment
Results posted on
2013-08-15
Participant Flow
Study 221 was conducted at 22 centers in Japan during the period of Jan 2008 to Sept 2009, and Study 224 was conducted at 5 centers in Japan from Aug 2009 to Jan 2011.
Study 224 was designed to evaluate the safety and efficacy of E7389 by collecting data from subjects who continued receiving E7389 after being transferred from Study 221. Thus, combined data of Study 221 and Study 224 are reported.
Participant milestones
| Measure |
Eribulin Mesylate
Eribulin mesylate 1.4 mg/m\^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
|
|---|---|
|
Study 221
STARTED
|
81
|
|
Study 221
COMPLETED
|
74
|
|
Study 221
NOT COMPLETED
|
7
|
|
Study 224
STARTED
|
6
|
|
Study 224
COMPLETED
|
0
|
|
Study 224
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Eribulin Mesylate
Eribulin mesylate 1.4 mg/m\^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
|
|---|---|
|
Study 221
Progressive Disease
|
4
|
|
Study 221
Physician Decision
|
3
|
|
Study 224
Progressive Disease
|
5
|
|
Study 224
Physician Decision
|
1
|
Baseline Characteristics
Study of E7389 for Advanced or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Eribulin Mesylate
n=80 Participants
Eribulin mesylate 1.4 mg/m\^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
|
|---|---|
|
Age Continuous
|
53.6 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every week during treatment and up to 30 days after last dose of study treatmentPopulation: Safety Analysis Set
Outcome measures
| Measure |
Eribulin Mesylate
n=81 Participants
Eribulin mesylate 1.4 mg/m\^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
|
|---|---|
|
Number of Subjects With Adverse Events.
|
81 Participants
|
SECONDARY outcome
Timeframe: Every 6 weeksPopulation: Full Analysis Set
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). Tumor assessments every 6 weeks.
Outcome measures
| Measure |
Eribulin Mesylate
n=80 Participants
Eribulin mesylate 1.4 mg/m\^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
|
|---|---|
|
Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Objective Response Rate
|
21.3 percentage of subjects
Interval 29.0 to 431.0
|
|
Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response
|
21.3 percentage of subjects
|
|
Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Stable Disease
|
37.5 percentage of subjects
|
|
Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive Disease
|
40.0 percentage of subjects
|
|
Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Not Evaluable
|
1.3 percentage of subjects
|
Adverse Events
Eribulin Mesylate
Serious events: 14 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eribulin Mesylate
n=81 participants at risk
Eribulin mesylate 1.4 mg/m\^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.2%
1/81
|
|
Eye disorders
Cataract
|
1.2%
1/81
|
|
Gastrointestinal disorders
Ascites
|
1.2%
1/81
|
|
Gastrointestinal disorders
Gastritis Hemorrhagic
|
1.2%
1/81
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/81
|
|
Gastrointestinal disorders
Stomatitis
|
2.5%
2/81
|
|
General disorders
Malaise
|
1.2%
1/81
|
|
General disorders
Oedema
|
1.2%
1/81
|
|
General disorders
Pain
|
1.2%
1/81
|
|
General disorders
Pyrexia
|
1.2%
1/81
|
|
Infections and infestations
Infection
|
2.5%
2/81
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
1.2%
1/81
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/81
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.2%
1/81
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
2.5%
2/81
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
1.2%
1/81
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.2%
1/81
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
1.2%
1/81
|
|
Vascular disorders
Hemorrhage
|
1.2%
1/81
|
Other adverse events
| Measure |
Eribulin Mesylate
n=81 participants at risk
Eribulin mesylate 1.4 mg/m\^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
14.8%
12/81
|
|
Blood and lymphatic system disorders
Leukopenia
|
98.8%
80/81
|
|
Blood and lymphatic system disorders
Lymphopenia
|
54.3%
44/81
|
|
Blood and lymphatic system disorders
Neutropenia
|
98.8%
80/81
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.6%
7/81
|
|
Gastrointestinal disorders
Constipation
|
17.3%
14/81
|
|
Gastrointestinal disorders
Diarrhea
|
18.5%
15/81
|
|
Gastrointestinal disorders
Nausea
|
44.4%
36/81
|
|
Gastrointestinal disorders
Stomatitis
|
40.7%
33/81
|
|
Gastrointestinal disorders
Vomiting
|
19.8%
16/81
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
9.9%
8/81
|
|
General disorders
Fatigue
|
45.7%
37/81
|
|
General disorders
Malaise
|
13.6%
11/81
|
|
General disorders
Pain
|
11.1%
9/81
|
|
General disorders
Pyrexia
|
30.9%
25/81
|
|
General disorders
Chest Pain
|
6.2%
5/81
|
|
General disorders
Oedema
|
8.6%
7/81
|
|
Infections and infestations
Nasopharyngitis
|
27.2%
22/81
|
|
Infections and infestations
Infection
|
7.4%
6/81
|
|
Investigations
Alanine Aminotransferase Increased
|
33.3%
27/81
|
|
Investigations
Aspartate Aminotransferase Increased
|
37.0%
30/81
|
|
Investigations
Blood Albumin Decreased
|
12.3%
10/81
|
|
Investigations
Blood Creatine Phophokinase Increased
|
28.4%
23/81
|
|
Investigations
Blood Glucose Increased
|
14.8%
12/81
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
19.8%
16/81
|
|
Investigations
C-Reactive Protein Increased
|
17.3%
14/81
|
|
Investigations
Gamma Glutamyltransferase Increased
|
27.2%
22/81
|
|
Investigations
Blood Urine Present
|
9.9%
8/81
|
|
Investigations
Hemoglobin Decreased
|
34.6%
28/81
|
|
Investigations
Weight Decreased
|
11.1%
9/81
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
22.2%
18/81
|
|
Investigations
Red Blood Cell Count Decreased
|
6.2%
5/81
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
46.9%
38/81
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.9%
8/81
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.3%
14/81
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.2%
5/81
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
7.4%
6/81
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.9%
8/81
|
|
Nervous system disorders
Dizziness
|
11.1%
9/81
|
|
Nervous system disorders
Dysgeusia
|
33.3%
27/81
|
|
Nervous system disorders
Headache
|
16.0%
13/81
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
23.5%
19/81
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
5/81
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.0%
13/81
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
9.9%
8/81
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
58.0%
47/81
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.6%
11/81
|
|
Blood and lymphatic system disorders
Anemia
|
8.6%
7/81
|
|
General disorders
Oedema Peripheral
|
6.2%
5/81
|
Additional Information
Tatsuo Watanabe, Study Director
Eisai
Phone: +81-3-3817-5252
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place