Trial Outcomes & Findings for A Phase II Study of E7389 in Patients With Breast Cancer, Previously Treated With Anthracycline, Taxane and Capecitabine (NCT NCT00246090)
NCT ID: NCT00246090
Last Updated: 2014-07-14
Results Overview
Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
298 participants
Primary outcome timeframe
Every two cycles
Results posted on
2014-07-14
Participant Flow
This study was recruited at 42 centers in US and 36 centers in EU during the period of Oct 2005 to Sep 2007.
Participant milestones
| Measure |
E7389 1.4 mg/m^2
E7389 1.4 mg/m\^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
|
|---|---|
|
Overall Study
STARTED
|
298
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
295
|
Reasons for withdrawal
| Measure |
E7389 1.4 mg/m^2
E7389 1.4 mg/m\^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
|
|---|---|
|
Overall Study
Adverse Event
|
25
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Progressive Disease
|
212
|
|
Overall Study
Clinical Progression
|
30
|
|
Overall Study
Physician Decision
|
11
|
|
Overall Study
Not Otherwise Specified
|
10
|
Baseline Characteristics
A Phase II Study of E7389 in Patients With Breast Cancer, Previously Treated With Anthracycline, Taxane and Capecitabine
Baseline characteristics by cohort
| Measure |
E7389 1.4 mg/m^2
n=291 Participants
E7389 1.4 mg/m\^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
|
|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
291 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
199 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every two cyclesPopulation: Eligible Population
Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).
Outcome measures
| Measure |
E7389 1.4 mg/m^2
n=269 Participants
E7389 1.4 mg/m\^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
|
|---|---|
|
Objective Response Rate
|
14.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: From first documented complete or partial response until disease progression or deathPopulation: Eligible Population
Complete response (CR) is defined as the disappearance of all lesions. Partial response (PR) is defined as 30% decrease in lesion diameter.
Outcome measures
| Measure |
E7389 1.4 mg/m^2
n=38 Participants
E7389 1.4 mg/m\^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
|
|---|---|
|
Duration of Response
|
176 Days
Interval 29.0 to 258.0
|
Adverse Events
E7389 1.4 mg/m^2
Serious events: 88 serious events
Other events: 290 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E7389 1.4 mg/m^2
n=291 participants at risk
E7389 1.4 mg/m\^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.0%
3/291
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.8%
11/291
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.34%
1/291
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
7/291
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.69%
2/291
|
|
Cardiac disorders
Cardiac Arrest
|
0.34%
1/291
|
|
Cardiac disorders
Pericardial Effusion
|
0.34%
1/291
|
|
Cardiac disorders
Pericarditis
|
0.34%
1/291
|
|
Cardiac disorders
Tachycardia
|
0.69%
2/291
|
|
Eye disorders
Diplopia
|
0.34%
1/291
|
|
Eye disorders
Macular Hole
|
0.34%
1/291
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.0%
3/291
|
|
Gastrointestinal disorders
Ascites
|
0.34%
1/291
|
|
Gastrointestinal disorders
Dysphagia
|
0.34%
1/291
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.34%
1/291
|
|
Gastrointestinal disorders
Nausea
|
1.0%
3/291
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
4/291
|
|
General disorders
Asthenia
|
0.69%
2/291
|
|
General disorders
Chest Pain
|
0.34%
1/291
|
|
General disorders
Death
|
0.34%
1/291
|
|
General disorders
Fatigue
|
0.34%
1/291
|
|
General disorders
Pain
|
1.4%
4/291
|
|
General disorders
Pyrexia
|
3.8%
11/291
|
|
Hepatobiliary disorders
Biliary Dilatation
|
0.34%
1/291
|
|
Infections and infestations
Bacteremia
|
0.34%
1/291
|
|
Infections and infestations
Bacterial Sepsis
|
0.34%
1/291
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.34%
1/291
|
|
Infections and infestations
Endocarditis
|
0.34%
1/291
|
|
Infections and infestations
Gastroenteritis
|
0.34%
1/291
|
|
Infections and infestations
Lymphangitis
|
0.34%
1/291
|
|
Infections and infestations
Neutropenic Infection
|
0.34%
1/291
|
|
Infections and infestations
Neutropenic Sepsis
|
0.34%
1/291
|
|
Infections and infestations
Pneumonia
|
0.69%
2/291
|
|
Infections and infestations
Pyelonephritis
|
0.34%
1/291
|
|
Infections and infestations
Respiratory Tract Infection
|
0.34%
1/291
|
|
Infections and infestations
Sepsis
|
0.69%
2/291
|
|
Infections and infestations
Septic Shock
|
0.34%
1/291
|
|
Infections and infestations
Urinary Tract Infection
|
0.69%
2/291
|
|
Injury, poisoning and procedural complications
Fall
|
0.34%
1/291
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.69%
2/291
|
|
Metabolism and nutrition disorders
Anorexia
|
0.34%
1/291
|
|
Metabolism and nutrition disorders
Dehydration
|
0.34%
1/291
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.34%
1/291
|
|
Metabolism and nutrition disorders
Hypovolemia
|
0.34%
1/291
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.34%
1/291
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.4%
4/291
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.34%
1/291
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.69%
2/291
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.34%
1/291
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.34%
1/291
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.34%
1/291
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis Carcinomatosa
|
0.34%
1/291
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
1.4%
4/291
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Pleural Effusion
|
0.34%
1/291
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous
|
1.0%
3/291
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Liver
|
0.69%
2/291
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Meninges
|
0.69%
2/291
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Retroperitoneum
|
0.34%
1/291
|
|
Nervous system disorders
Aphasia
|
0.34%
1/291
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.34%
1/291
|
|
Nervous system disorders
Convulsion
|
0.34%
1/291
|
|
Nervous system disorders
Peripheral Sensorimotor Neuropathy
|
0.34%
1/291
|
|
Nervous system disorders
Spinal Cord Compression
|
0.69%
2/291
|
|
Nervous system disorders
Syncope
|
0.34%
1/291
|
|
Psychiatric disorders
Confusional State
|
0.69%
2/291
|
|
Psychiatric disorders
Depression
|
0.34%
1/291
|
|
Psychiatric disorders
Mental Status Changes
|
0.34%
1/291
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
7/291
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.34%
1/291
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.4%
7/291
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.34%
1/291
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.69%
2/291
|
|
Renal and urinary disorders
Hydronephrosis
|
0.34%
1/291
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.34%
1/291
|
|
Renal and urinary disorders
Renal Failure
|
0.34%
1/291
|
|
Renal and urinary disorders
Urinary Retention
|
0.34%
1/291
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.34%
1/291
|
Other adverse events
| Measure |
E7389 1.4 mg/m^2
n=291 participants at risk
E7389 1.4 mg/m\^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
29.6%
86/291
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.5%
16/291
|
|
Blood and lymphatic system disorders
Leukopenia
|
22.0%
64/291
|
|
Blood and lymphatic system disorders
Neutropenia
|
59.8%
174/291
|
|
Eye disorders
Lacrimation Increased
|
10.7%
31/291
|
|
Gastrointestinal disorders
Abdominal Distention
|
5.5%
16/291
|
|
Gastrointestinal disorders
Abdominal Pain
|
13.1%
38/291
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
8.9%
26/291
|
|
Gastrointestinal disorders
Constipation
|
33.0%
96/291
|
|
Gastrointestinal disorders
Diarrhea
|
22.3%
65/291
|
|
Gastrointestinal disorders
Dry Mouth
|
8.6%
25/291
|
|
Gastrointestinal disorders
Dyspepsia
|
9.3%
27/291
|
|
Gastrointestinal disorders
Nausea
|
48.5%
141/291
|
|
Gastrointestinal disorders
Stomatitis
|
11.0%
32/291
|
|
Gastrointestinal disorders
Vomiting
|
24.7%
72/291
|
|
General disorders
Asthenia
|
38.5%
112/291
|
|
General disorders
Chest Pain
|
8.2%
24/291
|
|
General disorders
Fatigue
|
36.8%
107/291
|
|
General disorders
Mucosal Inflammation
|
15.1%
44/291
|
|
General disorders
Peripheral Edema
|
12.7%
37/291
|
|
General disorders
Pain
|
11.0%
32/291
|
|
General disorders
Pyrexia
|
30.2%
88/291
|
|
Infections and infestations
Urinary Tract Infection
|
12.0%
35/291
|
|
Investigations
Weight Decreased
|
10.0%
29/291
|
|
Metabolism and nutrition disorders
Anorexia
|
25.4%
74/291
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.9%
26/291
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.5%
48/291
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
15.8%
46/291
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
10.3%
30/291
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.8%
17/291
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
5.5%
16/291
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
6.9%
20/291
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
10.3%
30/291
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.4%
42/291
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.8%
17/291
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
13.1%
38/291
|
|
Nervous system disorders
Dizziness
|
9.6%
28/291
|
|
Nervous system disorders
Dysgeusia
|
13.7%
40/291
|
|
Nervous system disorders
Headache
|
21.0%
61/291
|
|
Nervous system disorders
Neuropathy
|
8.2%
24/291
|
|
Nervous system disorders
Neuropathy Peripheral
|
10.3%
30/291
|
|
Nervous system disorders
Paraesthesia
|
11.3%
33/291
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
9.6%
28/291
|
|
Psychiatric disorders
Anxiety
|
9.3%
27/291
|
|
Psychiatric disorders
Depression
|
8.9%
26/291
|
|
Psychiatric disorders
Insomnia
|
11.3%
33/291
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.6%
57/291
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
19.6%
57/291
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolarygeal Pain
|
6.9%
20/291
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
61.5%
179/291
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.5%
16/291
|
Additional Information
Eisai Inc.
Eisai Call Center
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place