Trial Outcomes & Findings for Study of E7389 in Patients With Advanced Solid Tumors (NCT NCT00069264)
NCT ID: NCT00069264
Last Updated: 2011-12-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
28 Days
Results posted on
2011-12-20
Participant Flow
Participant milestones
| Measure |
E7389
E7389 Dose-escalation starting at 0.25 mg/m\^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
E7389
E7389 Dose-escalation starting at 0.25 mg/m\^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Progressive Disease
|
23
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Discon Therapy
|
3
|
Baseline Characteristics
Study of E7389 in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
E7389
n=32 Participants
E7389 Dose-escalation starting at 0.25 mg/m\^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
|
|---|---|
|
Age Continuous
|
57.4 years
STANDARD_DEVIATION 11.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 DaysOutcome measures
| Measure |
E7389
n=32 Participants
E7389 Dose-escalation starting at 0.25 mg/m\^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
|
|---|---|
|
Determination of the Maximum Tolerated Dose
|
1.0 mg/m^2
|
Adverse Events
E7389
Serious events: 12 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E7389
n=32 participants at risk
E7389 Dose-escalation starting at 0.25 mg/m\^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
|
|---|---|
|
Gastrointestinal disorders
Ascites
|
9.4%
3/32
|
|
General disorders
Chest Pain
|
9.4%
3/32
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.1%
1/32
|
|
Infections and infestations
Klebsiella Infection
|
3.1%
1/32
|
|
Renal and urinary disorders
Renal Insufficiency
|
3.1%
1/32
|
|
General disorders
Pain
|
3.1%
1/32
|
|
General disorders
Fatigue
|
3.1%
1/32
|
|
Nervous system disorders
Spinal Cord Compression
|
3.1%
1/32
|
|
Nervous system disorders
Paraparesis
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.1%
1/32
|
|
Nervous system disorders
Anoxic Encephalopathy
|
3.1%
1/32
|
|
General disorders
Multi-Organ System Failure
|
3.1%
1/32
|
|
Infections and infestations
Sepsis
|
3.1%
1/32
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Anemia
|
3.1%
1/32
|
|
Infections and infestations
Catheter Related Infection
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.1%
1/32
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
3.1%
1/32
|
Other adverse events
| Measure |
E7389
n=32 participants at risk
E7389 Dose-escalation starting at 0.25 mg/m\^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
18.8%
6/32
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.1%
9/32
|
|
Cardiac disorders
Palpitations
|
6.2%
2/32
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
2/32
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
6.2%
2/32
|
|
Gastrointestinal disorders
Ascites
|
12.5%
4/32
|
|
Gastrointestinal disorders
Constipation
|
25.0%
8/32
|
|
Gastrointestinal disorders
Diarrhea
|
28.1%
9/32
|
|
Gastrointestinal disorders
Nausea
|
43.8%
14/32
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
4/32
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
8/32
|
|
General disorders
Chest Pain
|
6.2%
2/32
|
|
General disorders
Fatigue
|
59.4%
19/32
|
|
General disorders
Peripheral Edema
|
12.5%
4/32
|
|
General disorders
Pain
|
6.2%
2/32
|
|
General disorders
Pyrexia
|
15.6%
5/32
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.2%
2/32
|
|
Metabolism and nutrition disorders
Anorexia
|
43.8%
14/32
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
2/32
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
3/32
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
4/32
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
15.6%
5/32
|
|
Nervous system disorders
Dizziness
|
9.4%
3/32
|
|
Nervous system disorders
Headache
|
9.4%
3/32
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
2/32
|
|
Nervous system disorders
Neuropathy
|
9.4%
3/32
|
|
Nervous system disorders
Paraesthesia
|
9.4%
3/32
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
8/32
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.8%
6/32
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.6%
5/32
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
9.4%
3/32
|
Additional Information
Dr. Peter Tarassoff
Eisai Inc.
Phone: 888-422--4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place