Trial Outcomes & Findings for Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced and/or Metastatic Disease Stratified by Prior Chemotherapy (NCT NCT00278993)
NCT ID: NCT00278993
Last Updated: 2014-07-14
Results Overview
Bubley Criteria: Patients must have progressive disease to enter study. For outcomes, PSA response must show at least 50% decrease. Duration of response is the time from \>50% decrease from baseline to when there is a 50% decrease in nadir. PSA progressive disease- 25% increase from baseline or increase of 5 ng/mL along with measureable disease Stable disease- decline of less than 50% and not more than 25% increase.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
12 months
Results posted on
2014-07-14
Participant Flow
This study was recruited at 22 centers in U.S, UK, Spain and Hungary during the period of Feb 2006 to May 2009.
Participant milestones
| Measure |
E7389 Intravenous 1.4 mg/m2
E7389 intravenous 1.4 mg/m2 on a 3-week course
|
|---|---|
|
Overall Study
STARTED
|
108
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
107
|
Reasons for withdrawal
| Measure |
E7389 Intravenous 1.4 mg/m2
E7389 intravenous 1.4 mg/m2 on a 3-week course
|
|---|---|
|
Overall Study
Adverse Event
|
24
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Progressive Disease
|
65
|
|
Overall Study
Physician Decision
|
9
|
|
Overall Study
Not Otherwise Specified
|
4
|
Baseline Characteristics
Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced and/or Metastatic Disease Stratified by Prior Chemotherapy
Baseline characteristics by cohort
| Measure |
E7389 Intravenous 1.4 mg/m2
n=108 Participants
E7389 intravenous 1.4 mg/m2 on a 3-week course
|
|---|---|
|
Age, Continuous
|
71.0 years
STANDARD_DEVIATION 9.36 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
94 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Per Protocol Population
Bubley Criteria: Patients must have progressive disease to enter study. For outcomes, PSA response must show at least 50% decrease. Duration of response is the time from \>50% decrease from baseline to when there is a 50% decrease in nadir. PSA progressive disease- 25% increase from baseline or increase of 5 ng/mL along with measureable disease Stable disease- decline of less than 50% and not more than 25% increase.
Outcome measures
| Measure |
E7389 Intravenous 1.4 mg/m2
n=105 Participants
E7389 intravenous 1.4 mg/m2 on a 3-week course
|
|---|---|
|
Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria
Response
|
16.2 Percentage of Participants
|
|
Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria
Stable Disease
|
52.4 Percentage of Participants
|
|
Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria
Progressive Disease
|
29.5 Percentage of Participants
|
|
Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria
Unknown/Not Evaluated
|
1.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: 12 months.Population: Per Protocol Population
Duration of response is the time from \>50% decrease from baseline to when there is a 50% decrease in nadir.
Outcome measures
| Measure |
E7389 Intravenous 1.4 mg/m2
n=105 Participants
E7389 intravenous 1.4 mg/m2 on a 3-week course
|
|---|---|
|
Duration of Prostate Specific Antigen Response Based on Bubley Criteria
|
96 Days
Interval 31.0 to 938.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Per Protocol Population
From the date study treatment was initiated until the earliest date of the first PSA assessment that determined progressive disease, or the death of death if death occurred without disease progression.
Outcome measures
| Measure |
E7389 Intravenous 1.4 mg/m2
n=105 Participants
E7389 intravenous 1.4 mg/m2 on a 3-week course
|
|---|---|
|
Progression Free Survival
|
64 Days
Interval 1.0 to 979.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent to Treat Population
Outcome measures
| Measure |
E7389 Intravenous 1.4 mg/m2
n=108 Participants
E7389 intravenous 1.4 mg/m2 on a 3-week course
|
|---|---|
|
Overall Survival
|
567 Days
Interval 426.0 to 759.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Per Protocol 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 Intravenous 1.4 mg/m2
n=105 Participants
E7389 intravenous 1.4 mg/m2 on a 3-week course
|
|---|---|
|
Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Patients with measureable tumors
|
59 Percentage of Participants
|
|
Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Complete Response
|
0 Percentage of Participants
|
|
Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Partial Response
|
8.1 Percentage of Participants
|
|
Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Stable Disease
|
72.6 Percentage of Participants
|
|
Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Progressive Disease
|
8.1 Percentage of Participants
|
|
Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Unknown
|
11.3 Percentage of Participants
|
Adverse Events
E7389 Intravenous 1.4 mg/m2
Serious events: 34 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E7389 Intravenous 1.4 mg/m2
n=108 participants at risk
E7389 intravenous 1.4 mg/m2 on a 3-week course
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
2/108
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.8%
3/108
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
2/108
|
|
Blood and lymphatic system disorders
Abdominal Pain
|
0.93%
1/108
|
|
Blood and lymphatic system disorders
Diarrhea
|
1.9%
2/108
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.93%
1/108
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.93%
1/108
|
|
Gastrointestinal disorders
Melena
|
1.9%
2/108
|
|
Gastrointestinal disorders
Esophageal Ulcer Hemorrhage
|
0.93%
1/108
|
|
General disorders
Chest Pain
|
0.93%
1/108
|
|
General disorders
Edema Peripheral
|
0.93%
1/108
|
|
General disorders
Pyrexia
|
2.8%
3/108
|
|
General disorders
Suprpubic Pain
|
0.93%
1/108
|
|
Cardiac disorders
Bradycardia
|
1.9%
2/108
|
|
Cardiac disorders
Cardiac Arrest
|
2.8%
3/108
|
|
Cardiac disorders
Tachycardia
|
1.9%
2/108
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.93%
1/108
|
|
Infections and infestations
Pneumonia
|
3.7%
4/108
|
|
Infections and infestations
Sepsis
|
0.93%
1/108
|
|
Infections and infestations
Urinary Tract Infection
|
1.9%
2/108
|
|
Infections and infestations
Uriosepsis
|
2.8%
3/108
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
3/108
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.93%
1/108
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.93%
1/108
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.93%
1/108
|
|
Metabolism and nutrition disorders
Hypovolemia
|
0.93%
1/108
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.93%
1/108
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.93%
1/108
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.93%
1/108
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
1.9%
2/108
|
|
Nervous system disorders
Hemiparesis
|
0.93%
1/108
|
|
Nervous system disorders
Spinal Cord Compression
|
2.8%
3/108
|
|
Psychiatric disorders
Confusional State
|
0.93%
1/108
|
|
Renal and urinary disorders
Bladder Obstruction
|
0.93%
1/108
|
|
Renal and urinary disorders
Hematuria
|
0.93%
1/108
|
|
Renal and urinary disorders
Renal Colic
|
0.93%
1/108
|
|
Renal and urinary disorders
Renal Failure
|
3.7%
4/108
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.93%
1/108
|
|
Reproductive system and breast disorders
Prostatic Pain
|
0.93%
1/108
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis Allergic
|
0.93%
1/108
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.93%
1/108
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.93%
1/108
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.8%
3/108
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.93%
1/108
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.9%
2/108
|
|
Vascular disorders
Hypertension
|
0.93%
1/108
|
|
Vascular disorders
Peripheral Ischemia
|
0.93%
1/108
|
|
Vascular disorders
Thrombosis
|
0.93%
1/108
|
Other adverse events
| Measure |
E7389 Intravenous 1.4 mg/m2
n=108 participants at risk
E7389 intravenous 1.4 mg/m2 on a 3-week course
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
35.2%
38/108
|
|
Blood and lymphatic system disorders
Leukopenia
|
27.8%
30/108
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.6%
46/108
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.4%
8/108
|
|
Gastrointestinal disorders
Constipation
|
23.1%
25/108
|
|
Gastrointestinal disorders
Diarrhea
|
25.9%
28/108
|
|
Gastrointestinal disorders
Dry Mouth
|
5.6%
6/108
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
6/108
|
|
Gastrointestinal disorders
Nausea
|
24.1%
26/108
|
|
Gastrointestinal disorders
Vomiting
|
10.2%
11/108
|
|
General disorders
Asthenia
|
28.7%
31/108
|
|
General disorders
Fatigue
|
43.5%
47/108
|
|
General disorders
Mucosal Inflammation
|
5.6%
6/108
|
|
General disorders
Edema Peripheral
|
17.6%
19/108
|
|
General disorders
Pain
|
10.2%
11/108
|
|
General disorders
Pyrexia
|
16.7%
18/108
|
|
Infections and infestations
Urinary Tract Infection
|
9.3%
10/108
|
|
Investigations
Alanine Aminotransferase Increased
|
6.5%
7/108
|
|
Investigations
Aspartate Aminotransferase Increased
|
7.4%
8/108
|
|
Metabolism and nutrition disorders
Anorexia
|
20.4%
22/108
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
6/108
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.6%
6/108
|
|
Metabolism and nutrition disorders
Underweight
|
8.3%
9/108
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
9/108
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.2%
11/108
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
8.3%
9/108
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
9.3%
10/108
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
5.6%
6/108
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
6.5%
7/108
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.3%
10/108
|
|
Nervous system disorders
Dizziness
|
7.4%
8/108
|
|
Nervous system disorders
Dysgeusia
|
4.6%
5/108
|
|
Nervous system disorders
Headache
|
7.4%
8/108
|
|
Nervous system disorders
Neuropathy
|
7.4%
8/108
|
|
Nervous system disorders
Neuropathy Peripheral
|
13.9%
15/108
|
|
Nervous system disorders
Paraesthesia
|
12.0%
13/108
|
|
Psychiatric disorders
Insomnia
|
6.5%
7/108
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
8/108
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
9/108
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.5%
20/108
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
7/108
|
|
Vascular disorders
Hot Flush
|
5.6%
6/108
|
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