Trial Outcomes & Findings for Phase I Clinical Study of E7389 (NCT NCT00326950)
NCT ID: NCT00326950
Last Updated: 2012-03-08
Results Overview
DLT is an adverse drug reaction defined as 1)Grade 4 neutropenia for 5 days, 2)\>/=Grade 3 febrile neutropenia, 3)\>/=Grade 3 neutropenia requiring iv antibiotics, 4)Grade 4 thrombocytopenia, 5)\>/=Grade 3 nonhematologic toxicity, 6)Omission of study drug on Day 8 due to \>/=Grade 3 neutropenia or thrombocytopenia or investigator decision.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
3 weeks
Results posted on
2012-03-08
Participant Flow
This study was recruited at 1 center in Japan during the period of May 2006 to Jan 2008
Participant milestones
| Measure |
E7389
E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m\^2, with planned dose levels of 1.0, 1.4, \& 2.0 mg/m\^2.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
E7389
E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m\^2, with planned dose levels of 1.0, 1.4, \& 2.0 mg/m\^2.
|
|---|---|
|
Overall Study
Progressive Disease
|
1
|
Baseline Characteristics
Phase I Clinical Study of E7389
Baseline characteristics by cohort
| Measure |
E7389
n=15 Participants
E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m\^2, with planned dose levels of 1.0, 1.4, \& 2.0 mg/m\^2.
|
|---|---|
|
Age Continuous
|
58.1 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeksDLT is an adverse drug reaction defined as 1)Grade 4 neutropenia for 5 days, 2)\>/=Grade 3 febrile neutropenia, 3)\>/=Grade 3 neutropenia requiring iv antibiotics, 4)Grade 4 thrombocytopenia, 5)\>/=Grade 3 nonhematologic toxicity, 6)Omission of study drug on Day 8 due to \>/=Grade 3 neutropenia or thrombocytopenia or investigator decision.
Outcome measures
| Measure |
E7389
n=15 Participants
E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m\^2, with planned dose levels of 1.0, 1.4, 2.0 mg/m\^2.
|
|---|---|
|
Number of Subjects Who Experienced Dose Limiting Toxicity (DLT)
|
5 participants
|
PRIMARY outcome
Timeframe: 3 WeeksMTD was the lowest dose at which a dose limiting toxicity occurred.
Outcome measures
| Measure |
E7389
n=15 Participants
E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m\^2, with planned dose levels of 1.0, 1.4, 2.0 mg/m\^2.
|
|---|---|
|
Maximum Tolerated Dose (MTD)
|
2.0 mg/m^2
|
SECONDARY outcome
Timeframe: 3 weeksOutcome measures
Outcome data not reported
Adverse Events
E7389
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E7389
n=15 participants at risk
E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m\^2, with planned dose levels of 1.0, 1.4, \& 2.0 mg/m\^2.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
13.3%
2/15
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
1/15
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15
|
|
Blood and lymphatic system disorders
Myelodysplastic Syndrome
|
6.7%
1/15
|
Other adverse events
| Measure |
E7389
n=15 participants at risk
E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m\^2, with planned dose levels of 1.0, 1.4, \& 2.0 mg/m\^2.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
33.3%
5/15
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
2/15
|
|
Injury, poisoning and procedural complications
Pharyngitis
|
6.7%
1/15
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15
|
|
Infections and infestations
Urinary Tract Infection
|
6.7%
1/15
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
9/15
|
|
Nervous system disorders
Convulsion
|
6.7%
1/15
|
|
Nervous system disorders
Dysgeusia
|
13.3%
2/15
|
|
Nervous system disorders
Headache
|
13.3%
2/15
|
|
Nervous system disorders
Neuralgia
|
6.7%
1/15
|
|
Nervous system disorders
Neuropathy
|
6.7%
1/15
|
|
Nervous system disorders
Neuropathy Peripheral
|
20.0%
3/15
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
13.3%
2/15
|
|
Eye disorders
Lacrimation Increased
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
3/15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea Exertional
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.3%
2/15
|
|
Gastrointestinal disorders
Constipation
|
33.3%
5/15
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
1/15
|
|
Gastrointestinal disorders
Gingivitis
|
6.7%
1/15
|
|
Gastrointestinal disorders
Nausea
|
60.0%
9/15
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
3/15
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
5/15
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
53.3%
8/15
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Hemorrhage Subcutaneous
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.7%
4/15
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
6.7%
1/15
|
|
General disorders
Fatigue
|
60.0%
9/15
|
|
General disorders
Edema
|
20.0%
3/15
|
|
General disorders
Edema Peripheral
|
6.7%
1/15
|
|
General disorders
Pain
|
6.7%
1/15
|
|
General disorders
Pyrexia
|
33.3%
5/15
|
|
Investigations
Alanine Aminotransferase Increased
|
40.0%
6/15
|
|
Investigations
Aspartate Aminotransferase Increased
|
60.0%
9/15
|
|
Investigations
Blood Albumin Decreased
|
33.3%
5/15
|
|
Investigations
Blood Bilirubin Increased
|
6.7%
1/15
|
|
Investigations
Blood Calcium Increased
|
6.7%
1/15
|
|
Investigations
Blood Chloride Increased
|
13.3%
2/15
|
|
Investigations
Blood Cholesterol Decreased
|
6.7%
1/15
|
|
Investigations
Blood Cholesterol Increased
|
6.7%
1/15
|
|
Investigations
Blood Creatine Phophokinase Increased
|
26.7%
4/15
|
|
Investigations
Blood Creatinine Increased
|
6.7%
1/15
|
|
Investigations
Blood Glucose Increased
|
80.0%
12/15
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
20.0%
3/15
|
|
Investigations
Blood Potassium Decreased
|
13.3%
2/15
|
|
Investigations
Blood Sodium Decreased
|
20.0%
3/15
|
|
Investigations
Blood Urea Decreased
|
6.7%
1/15
|
|
Investigations
Blood Urea Increased
|
6.7%
1/15
|
|
Investigations
C-Reactive Protein Increased
|
66.7%
10/15
|
|
Investigations
Electrocardiogram QT Prolonged
|
6.7%
1/15
|
|
Investigations
Electrocardiogram ST Segment Depression
|
6.7%
1/15
|
|
Investigations
Gamma Glutamyltransferase Increased
|
33.3%
5/15
|
|
Investigations
Glucose Urine Present
|
20.0%
3/15
|
|
Investigations
Blood Urine Present
|
13.3%
2/15
|
|
Investigations
Hemoglobin Decreased
|
60.0%
9/15
|
|
Investigations
Lymphocyte Count Decreased
|
86.7%
13/15
|
|
Investigations
Neutrophil Count Decreased
|
80.0%
12/15
|
|
Investigations
Neutrophil Count Increased
|
13.3%
2/15
|
|
Investigations
Platelet Count Decreased
|
33.3%
5/15
|
|
Investigations
Protein Total Decreased
|
6.7%
1/15
|
|
Investigations
Red Blood Cell Count Decreased
|
60.0%
9/15
|
|
Investigations
Weight Decreased
|
6.7%
1/15
|
|
Investigations
White Blood Cell Count Decreased
|
86.7%
13/15
|
|
Investigations
White Blood Cell Count Increased
|
13.3%
2/15
|
|
Investigations
Protein Urine Present
|
26.7%
4/15
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
20.0%
3/15
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
6.7%
1/15
|
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