Trial Outcomes & Findings for Study of E7389 Administered Once Every 3 Weeks In Patients With Advanced Solid Tumors (NCT NCT00069277)
NCT ID: NCT00069277
Last Updated: 2012-04-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
12 Weeks
Results posted on
2012-04-11
Participant Flow
This study was recruited at 2 centers in U.S.during the period of Aug 2003 to Apr 2005.
Participant milestones
| Measure |
E7389 Dose-Escalating
E7389 dose-escalation starting at 0.25 mg/m\^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
E7389 Dose-Escalating
E7389 dose-escalation starting at 0.25 mg/m\^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Progressive Disease
|
15
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Study of E7389 Administered Once Every 3 Weeks In Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
E7389 Dose-Escalating
n=21 Participants
E7389 dose-escalation starting at 0.25 mg/m\^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
|
|---|---|
|
Age, Customized
Mean (+/- Standard Deviation)
|
59.0 participants
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksOutcome measures
| Measure |
E7389 Dose-Escalating
n=21 Participants
E7389 dose-escalation starting at 0.25 mg/m\^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
|
|---|---|
|
Response and Progression Will be Evaluated in This Study Using the New International Criteria Proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in Only the Largest Diameter of the Tumor Lesions Are Used.
partial response
|
1 participants
|
|
Response and Progression Will be Evaluated in This Study Using the New International Criteria Proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in Only the Largest Diameter of the Tumor Lesions Are Used.
stable disease
|
12 participants
|
|
Response and Progression Will be Evaluated in This Study Using the New International Criteria Proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in Only the Largest Diameter of the Tumor Lesions Are Used.
progressive Disease
|
7 participants
|
Adverse Events
E7389 Dose-Escalating
Serious events: 10 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E7389 Dose-Escalating
n=21 participants at risk
E7389 dose-escalation starting at 0.25 mg/m\^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
|
|---|---|
|
Gastrointestinal disorders
Ileus
|
4.8%
1/21
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
1/21
|
|
Cardiac disorders
Myocardial Infarction
|
4.8%
1/21
|
|
Investigations
Hyponatremia
|
4.8%
1/21
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
28.6%
6/21
|
|
General disorders
Pyrexia
|
4.8%
1/21
|
|
Infections and infestations
Infection
|
4.8%
1/21
|
|
Nervous system disorders
Headache
|
4.8%
1/21
|
|
General disorders
Fatigue
|
4.8%
1/21
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
9.5%
2/21
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.8%
1/21
|
|
Infections and infestations
Pneumonia
|
4.8%
1/21
|
|
Infections and infestations
Bacteremia
|
4.8%
1/21
|
|
Infections and infestations
Cellulitis
|
4.8%
1/21
|
|
Gastrointestinal disorders
Dysphagia
|
4.8%
1/21
|
Other adverse events
| Measure |
E7389 Dose-Escalating
n=21 participants at risk
E7389 dose-escalation starting at 0.25 mg/m\^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
6/21
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
28.6%
6/21
|
|
Blood and lymphatic system disorders
Leukopenia
|
19.0%
4/21
|
|
Blood and lymphatic system disorders
Neutropenia
|
38.1%
8/21
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.5%
2/21
|
|
Cardiac disorders
Tachycardia
|
9.5%
2/21
|
|
Gastrointestinal disorders
Abdominal Distention
|
9.5%
2/21
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
3/21
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
9.5%
2/21
|
|
Gastrointestinal disorders
Constipation
|
28.6%
6/21
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
3/21
|
|
Gastrointestinal disorders
Dry Mouth
|
9.5%
2/21
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
9.5%
2/21
|
|
Gastrointestinal disorders
Nausea
|
23.8%
5/21
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
2/21
|
|
General disorders
Chest Pain
|
14.3%
3/21
|
|
General disorders
Fatigue
|
52.4%
11/21
|
|
General disorders
Mucosal Inflammation
|
9.5%
2/21
|
|
General disorders
Peripheral Edema
|
14.3%
3/21
|
|
General disorders
Pyrexia
|
14.3%
3/21
|
|
Infections and infestations
Oral Candidiasis
|
9.5%
2/21
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.5%
2/21
|
|
Infections and infestations
Urinary Tract Infection
|
9.5%
2/21
|
|
Investigations
Alanine Aminotransferase Increased
|
14.3%
3/21
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
9.5%
2/21
|
|
Investigations
Weight Decreased
|
19.0%
4/21
|
|
Investigations
White Blood Cell Count Decreased
|
9.5%
2/21
|
|
Metabolism and nutrition disorders
Anorexia
|
19.0%
4/21
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
19.0%
4/21
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.5%
2/21
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.5%
2/21
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
23.8%
5/21
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
9.5%
2/21
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.0%
4/21
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
14.3%
3/21
|
|
Nervous system disorders
Dizziness
|
19.0%
4/21
|
|
Nervous system disorders
Headache
|
14.3%
3/21
|
|
Psychiatric disorders
Insomnia
|
14.3%
3/21
|
|
Renal and urinary disorders
Dysuria
|
14.3%
3/21
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.0%
4/21
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.5%
2/21
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea Exertional
|
9.5%
2/21
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
9.5%
2/21
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
9.5%
2/21
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
9.5%
2/21
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
7/21
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
14.3%
3/21
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.5%
2/21
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
14.3%
3/21
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
19.0%
4/21
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
9.5%
2/21
|
|
Vascular disorders
Hypotension
|
9.5%
2/21
|
Additional Information
Eisai Call Center
Eisai Inc
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place