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E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00400829
Recruitment Status : Completed
First Posted : November 17, 2006
Results First Posted : January 7, 2015
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Intervention Drug: eribulin mesylate
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I
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Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

eribulin mesylate: Given IV

Period Title: Overall Study
Started 66
Completed 66
Not Completed 0
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

eribulin mesylate: Given IV

Overall Number of Baseline Participants 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 66 participants
63
(35 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants
Female
35
  53.0%
Male
31
  47.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 66 participants
66
1.Primary Outcome
Title Objective Response Rate (CR or PR) According to RECIST Criteria
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame Tumor measurements repeated every 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
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Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

eribulin mesylate: Given IV

Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: percentage of patients responding
5
2.Secondary Outcome
Title Overall Survival
Hide Description Will be estimated using the product-limit method of Kaplan and Meier.
Time Frame From start of treatment to death from any cause, assessed up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
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Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

eribulin mesylate: Given IV

Overall Number of Participants Analyzed 66
Median (95% Confidence Interval)
Unit of Measure: Months
11.6
(8.2 to 13.7)
3.Secondary Outcome
Title Progression Free Survival
Hide Description Will be estimated using the product-limit method of Kaplan and Meier.
Time Frame From start of treatment to the time of documented progression, assessed up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

eribulin mesylate: Given IV

Overall Number of Participants Analyzed 66
Median (95% Confidence Interval)
Unit of Measure: Months
2.7
(1.3 to 3.9)
Time Frame Adverse Events were recorded over a 40 month period.
Adverse Event Reporting Description "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
 
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

eribulin mesylate: Given IV

All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%) # Events
Total   23/66 (34.85%)    
Blood and lymphatic system disorders   
Febrile neutropenia * 1  1/66 (1.52%)  1
Hemoglobin decreased * 2  1/66 (1.52%)  1
Endocrine disorders   
Adrenal insufficiency * 2  1/66 (1.52%)  1
Gastrointestinal disorders   
Abdominal pain * 2  1/66 (1.52%)  1
Constipation * 2  3/66 (4.55%)  3
Nausea * 2  3/66 (4.55%)  3
Vomiting * 2  1/66 (1.52%)  1
General disorders   
Death * 2  2/66 (3.03%)  2
Disease progression * 2  1/66 (1.52%)  1
Fatigue * 2  3/66 (4.55%)  3
Fever * 2  1/66 (1.52%)  1
Immune system disorders   
Hypersensitivity * 2  1/66 (1.52%)  1
Infections and infestations   
Laryngitis * 2  1/66 (1.52%)  1
Investigations   
Leukocyte count decreased * 2  2/66 (3.03%)  3
Leukopenia * 1  1/66 (1.52%)  1
Neutrophil count decreased * 2  13/66 (19.70%)  19
Metabolism and nutrition disorders   
Anorexia * 2  2/66 (3.03%)  2
Dehydration * 2  1/66 (1.52%)  1
Serum sodium decreased * 2  1/66 (1.52%)  1
Musculoskeletal and connective tissue disorders   
Back pain * 2  1/66 (1.52%)  1
Nervous system disorders   
Depressed level of consciousness * 2  1/66 (1.52%)  1
Intracranial hemorrhage * 2  1/66 (1.52%)  1
Psychiatric disorders   
Insomnia * 2  1/66 (1.52%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 2  2/66 (3.03%)  2
Dyspnea * 2  2/66 (3.03%)  2
Hypoxia * 2  1/66 (1.52%)  1
Pneumonitis * 2  1/66 (1.52%)  1
Skin and subcutaneous tissue disorders   
Pain of skin * 2  1/66 (1.52%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra9.0
2
Term from vocabulary, meddra10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I
Affected / at Risk (%) # Events
Total   65/66 (98.48%)    
Blood and lymphatic system disorders   
Hemoglobin decreased * 1  46/66 (69.70%)  159
Cardiac disorders   
Cardiac disorder * 1  1/66 (1.52%)  1
Left ventricular failure * 1  1/66 (1.52%)  1
Palpitations * 1  1/66 (1.52%)  1
Pericardial effusion * 1  1/66 (1.52%)  1
Sinus tachycardia * 1  3/66 (4.55%)  4
Ear and labyrinth disorders   
Hearing loss * 1  1/66 (1.52%)  1
Eye disorders   
Dry eye syndrome * 1  1/66 (1.52%)  1
Extraocular muscle paresis * 1  1/66 (1.52%)  3
Eye disorder * 1  1/66 (1.52%)  2
Vision blurred * 1  3/66 (4.55%)  4
Watering eyes * 1  2/66 (3.03%)  7
Gastrointestinal disorders   
Abdominal distension * 1  1/66 (1.52%)  1
Abdominal pain * 1  10/66 (15.15%)  14
Ascites * 1  1/66 (1.52%)  1
Constipation * 1  17/66 (25.76%)  29
Diarrhea * 1  7/66 (10.61%)  18
Dyspepsia * 1  7/66 (10.61%)  11
Dysphagia * 1  2/66 (3.03%)  3
Ear, nose and throat examination abnormal * 1  8/66 (12.12%)  10
Esophageal pain * 1  1/66 (1.52%)  1
Gastritis * 1  1/66 (1.52%)  1
Gastrointestinal disorder * 2  2/66 (3.03%)  3
Mucositis oral * 1  2/66 (3.03%)  2
Nausea * 1  16/66 (24.24%)  28
Oral hemorrhage * 1  1/66 (1.52%)  1
Oral pain * 1  1/66 (1.52%)  1
Vomiting * 1  8/66 (12.12%)  8
General disorders   
Chest pain * 1  9/66 (13.64%)  14
Chills * 1  2/66 (3.03%)  4
Death * 1  11/66 (16.67%)  11
Disease progression * 1  30/66 (45.45%)  30
Edema limbs * 1  11/66 (16.67%)  25
Fatigue * 1  45/66 (68.18%)  137
Fever * 1  9/66 (13.64%)  14
Gait abnormal * 1  1/66 (1.52%)  1
General symptom * 1  4/66 (6.06%)  14
Injection site reaction * 1  1/66 (1.52%)  2
Localized edema * 1  1/66 (1.52%)  6
Pain * 1  7/66 (10.61%)  10
Hepatobiliary disorders   
Hepatic pain * 1  2/66 (3.03%)  4
Infections and infestations   
Bronchitis * 1  5/66 (7.58%)  5
Catheter related infection * 1  1/66 (1.52%)  1
Eye infection * 1  1/66 (1.52%)  1
Infection * 1  1/66 (1.52%)  14
Paranasal sinus infection * 1  1/66 (1.52%)  2
Pneumonia * 1  2/66 (3.03%)  3
Sinusitis * 1  2/66 (3.03%)  2
Skin infection * 1  1/66 (1.52%)  1
Upper respiratory infection * 1  1/66 (1.52%)  1
Urinary tract infection * 1  3/66 (4.55%)  3
Investigations   
Activated partial thromboplastin time prolonged * 1  1/66 (1.52%)  2
Alanine aminotransferase increased * 1  11/66 (16.67%)  31
Alkaline phosphatase increased * 1  12/66 (18.18%)  43
Aspartate aminotransferase increased * 1  15/66 (22.73%)  25
Bilirubin increased * 1  5/66 (7.58%)  5
Creatinine increased * 1  2/66 (3.03%)  3
Forced expiratory volume decreased * 1  1/66 (1.52%)  1
INR increased * 1  2/66 (3.03%)  7
Laboratory test abnormal * 1  2/66 (3.03%)  4
Leukocyte count decreased * 1  38/66 (57.58%)  147
Leukopenia * 2  4/66 (6.06%)  6
Lymphocyte count decreased * 1  27/66 (40.91%)  104
Neutrophil count decreased * 1  38/66 (57.58%)  126
Platelet count decreased * 1  7/66 (10.61%)  10
Serum cholesterol increased * 1  2/66 (3.03%)  4
Weight loss * 1  4/66 (6.06%)  6
Metabolism and nutrition disorders   
Anorexia * 1  24/66 (36.36%)  49
Blood bicarbonate decreased * 1  4/66 (6.06%)  7
Blood glucose increased * 1  31/66 (46.97%)  84
Dehydration * 1  4/66 (6.06%)  11
Hyperglycemia * 2  1/66 (1.52%)  1
Hypoalbuminemia * 2  2/66 (3.03%)  2
Serum albumin decreased * 1  20/66 (30.30%)  48
Serum calcium decreased * 1  6/66 (9.09%)  7
Serum calcium increased * 1  6/66 (9.09%)  8
Serum glucose decreased * 1  4/66 (6.06%)  5
Serum magnesium decreased * 1  5/66 (7.58%)  10
Serum magnesium increased * 1  1/66 (1.52%)  1
Serum phosphate decreased * 1  7/66 (10.61%)  13
Serum potassium decreased * 1  9/66 (13.64%)  13
Serum potassium increased * 1  4/66 (6.06%)  6
Serum sodium decreased * 1  12/66 (18.18%)  23
Serum sodium increased * 1  1/66 (1.52%)  1
Serum triglycerides increased * 1  2/66 (3.03%)  4
Musculoskeletal and connective tissue disorders   
Back pain * 1  10/66 (15.15%)  37
Bone pain * 1  6/66 (9.09%)  10
Chest wall pain * 1  7/66 (10.61%)  20
Joint disorder * 1  1/66 (1.52%)  2
Joint pain * 1  8/66 (12.12%)  22
Muscle weakness * 1  6/66 (9.09%)  8
Muscle weakness lower limb * 1  1/66 (1.52%)  1
Musculoskeletal disorder * 1  3/66 (4.55%)  5
Myalgia * 1  12/66 (18.18%)  26
Neck pain * 1  2/66 (3.03%)  2
Pain in extremity * 1  11/66 (16.67%)  22
Nervous system disorders   
Acoustic nerve disorder NOS * 1  1/66 (1.52%)  1
Ataxia * 1  1/66 (1.52%)  7
Cognitive disturbance * 1  1/66 (1.52%)  1
Depressed level of consciousness * 1  1/66 (1.52%)  1
Dizziness * 1  11/66 (16.67%)  15
Headache * 1  10/66 (15.15%)  15
Neuralgia * 1  1/66 (1.52%)  2
Neurological disorder NOS * 1  2/66 (3.03%)  3
Peripheral motor neuropathy * 1  2/66 (3.03%)  4
Peripheral sensory neuropathy * 1  27/66 (40.91%)  67
Seizure * 1  1/66 (1.52%)  1
Syncope * 1  2/66 (3.03%)  2
Taste alteration * 1  2/66 (3.03%)  7
Tremor * 1  1/66 (1.52%)  2
Psychiatric disorders   
Anxiety * 1  6/66 (9.09%)  20
Confusion * 1  2/66 (3.03%)  2
Depression * 1  5/66 (7.58%)  8
Insomnia * 1  6/66 (9.09%)  9
Renal and urinary disorders   
Glomerular filtration rate decreased * 1  1/66 (1.52%)  3
Hemorrhage urinary tract * 1  1/66 (1.52%)  1
Protein urine positive * 1  3/66 (4.55%)  4
Urethral pain * 1  1/66 (1.52%)  1
Urinary frequency * 1  1/66 (1.52%)  2
Urinary incontinence * 1  1/66 (1.52%)  1
Reproductive system and breast disorders   
Testicular pain * 1  1/66 (1.52%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis * 1  5/66 (7.58%)  13
Bronchial obstruction * 1  1/66 (1.52%)  1
Bronchopulmonary hemorrhage * 1  1/66 (1.52%)  1
Bronchospasm * 1  5/66 (7.58%)  14
Cough * 1  28/66 (42.42%)  56
Dyspnea * 1  22/66 (33.33%)  70
Hemoptysis * 1  1/66 (1.52%)  1
Hemorrhage nasal * 1  2/66 (3.03%)  2
Laryngeal pain * 1  1/66 (1.52%)  1
Nasal congestion * 1  2/66 (3.03%)  3
Pharyngolaryngeal pain * 1  1/66 (1.52%)  1
Pleural effusion * 1  1/66 (1.52%)  1
Pleuritic pain * 1  1/66 (1.52%)  1
Pneumonitis * 1  1/66 (1.52%)  1
Respiratory disorder * 1  3/66 (4.55%)  6
Respiratory tract hemorrhage * 1  2/66 (3.03%)  2
Voice alteration * 1  4/66 (6.06%)  12
Skin and subcutaneous tissue disorders   
Alopecia * 1  14/66 (21.21%)  54
Dry skin * 1  2/66 (3.03%)  7
Nail disorder * 1  1/66 (1.52%)  5
Rash acneiform * 1  1/66 (1.52%)  1
Rash desquamating * 1  6/66 (9.09%)  7
Sweating * 1  2/66 (3.03%)  2
Vascular disorders   
Flushing * 1  1/66 (1.52%)  2
Hypertension * 1  2/66 (3.03%)  2
Hypotension * 1  3/66 (4.55%)  6
Phlebitis * 1  1/66 (1.52%)  5
Thrombosis * 1  1/66 (1.52%)  6
Vascular disorder * 1  2/66 (3.03%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra10.0
2
Term from vocabulary, meddra9.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: DCC Project Administrator
Organization: California Cancer Consortium
Phone: 626-256-4673 ext 60094
EMail: CCCP@coh.org
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00400829     History of Changes
Other Study ID Numbers: NCI-2009-01159
NCI-2009-01159 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000514516
PHII-74 ( Other Identifier: City of Hope )
7437 ( Other Identifier: CTEP )
N01CM62204 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62209 ( U.S. NIH Grant/Contract )
First Submitted: November 16, 2006
First Posted: November 17, 2006
Results First Submitted: December 23, 2014
Results First Posted: January 7, 2015
Last Update Posted: January 7, 2015