Trial Outcomes & Findings for Phase II Study Of E7389, Halichondrin B Analogue, In Patients With Advanced Non-Small Cell Lung Cancer, NSCLC, Who Progressed During Or After Platinum-Based Doublet Chemotherapy (NCT NCT00100932)
NCT ID: NCT00100932
Last Updated: 2012-03-27
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
From start of treatment until disease progression or recurrence
Results posted on
2012-03-27
Participant Flow
This study was recruited at 29 centers in the US during the period of Dec 2004 to Apr 2006.
Participant milestones
| Measure |
E7389 28 Day Cycle
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Cycle
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
28
|
|
Overall Study
COMPLETED
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
73
|
27
|
Reasons for withdrawal
| Measure |
E7389 28 Day Cycle
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Cycle
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
0
|
|
Overall Study
Progressive Disease
|
44
|
18
|
|
Overall Study
Physician Decision
|
7
|
5
|
|
Overall Study
Other
|
5
|
2
|
Baseline Characteristics
Phase II Study Of E7389, Halichondrin B Analogue, In Patients With Advanced Non-Small Cell Lung Cancer, NSCLC, Who Progressed During Or After Platinum-Based Doublet Chemotherapy
Baseline characteristics by cohort
| Measure |
E7389 28 Day Cycle
n=77 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Cycle
n=26 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62.0 years
STANDARD_DEVIATION 10.59 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 8.97 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 10.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=5 Participants
|
26 participants
n=7 Participants
|
103 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until disease progression or recurrencePopulation: Intent to Treat/Safety 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 28 Day Cycle
n=77 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Cycle
n=26 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Overall Objective Response Rate (ORR)
|
11.7 percentage of participants
|
3.8 percentage of participants
|
SECONDARY outcome
Timeframe: From time of CR or PR until recurrence or progressive diseasePopulation: Intent to Treat/Safety Population
Measured from the time that measurement criteria were met for complete response (CR) and partial response (PR) until the first date that recurrence or progressive disease was objectively documented.
Outcome measures
| Measure |
E7389 28 Day Cycle
n=77 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Cycle
n=26 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Duration of Response
|
171 Days
Interval 50.0 to 291.0
|
176 Days
Interval 176.0 to 176.0
|
SECONDARY outcome
Timeframe: From start of study medication until progressive disease or deathPopulation: Intent to Treat/Safety Population
Defined as the time from the start of study medication until progressive disease or death from any cause during the study period.
Outcome measures
| Measure |
E7389 28 Day Cycle
n=77 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Cycle
n=26 Participants
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Progression Free Survival
|
106 Days
Interval 1.0 to 408.0
|
78 Days
Interval 1.0 to 218.0
|
SECONDARY outcome
Timeframe: From time of start of study medication until deathDefined as the time from the start of study medication until death from any cause.
Outcome measures
Outcome data not reported
Adverse Events
E7389 28 Day Cycle
Serious events: 33 serious events
Other events: 77 other events
Deaths: 0 deaths
E7389 21 Day Cycle
Serious events: 11 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E7389 28 Day Cycle
n=77 participants at risk
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Cycle
n=26 participants at risk
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.6%
2/77
|
3.8%
1/26
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
1/77
|
3.8%
1/26
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.3%
1/77
|
0.00%
0/26
|
|
Cardiac disorders
Cardiac Tamponade
|
1.3%
1/77
|
0.00%
0/26
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.3%
1/77
|
0.00%
0/26
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/77
|
0.00%
0/26
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
2/77
|
0.00%
0/26
|
|
Gastrointestinal disorders
Diverticular Perforation
|
1.3%
1/77
|
0.00%
0/26
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
1/77
|
0.00%
0/26
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/77
|
0.00%
0/26
|
|
Gastrointestinal disorders
Stomatitis
|
1.3%
1/77
|
0.00%
0/26
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/77
|
3.8%
1/26
|
|
General disorders
Asthenia
|
1.3%
1/77
|
0.00%
0/26
|
|
General disorders
Chest Pain
|
1.3%
1/77
|
0.00%
0/26
|
|
General disorders
Disease Progression
|
6.5%
5/77
|
0.00%
0/26
|
|
General disorders
Pain
|
2.6%
2/77
|
3.8%
1/26
|
|
General disorders
Pyrexia
|
3.9%
3/77
|
0.00%
0/26
|
|
Infections and infestations
Cellulitis
|
0.00%
0/77
|
3.8%
1/26
|
|
Infections and infestations
Neutropenic Sepsis
|
1.3%
1/77
|
0.00%
0/26
|
|
Infections and infestations
Pneumonia
|
3.9%
3/77
|
3.8%
1/26
|
|
Infections and infestations
Pyrothorax
|
1.3%
1/77
|
0.00%
0/26
|
|
Infections and infestations
Sepsis
|
1.3%
1/77
|
0.00%
0/26
|
|
Investigations
Blood Pressure Systolic Inspiratory Decreased
|
0.00%
0/77
|
3.8%
1/26
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
2/77
|
0.00%
0/26
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.3%
1/77
|
0.00%
0/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
5.2%
4/77
|
0.00%
0/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
1.3%
1/77
|
0.00%
0/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
1.3%
1/77
|
0.00%
0/26
|
|
Nervous system disorders
Coordination Abnormal
|
1.3%
1/77
|
3.8%
1/26
|
|
Nervous system disorders
Dysarthria
|
1.3%
1/77
|
0.00%
0/26
|
|
Nervous system disorders
Neuropathy Peripheral
|
1.3%
1/77
|
0.00%
0/26
|
|
Nervous system disorders
Status Epilepticus
|
1.3%
1/77
|
0.00%
0/26
|
|
Psychiatric disorders
Hallucinations, Visual
|
1.3%
1/77
|
0.00%
0/26
|
|
Psychiatric disorders
Mental Status Changes
|
1.3%
1/77
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.9%
3/77
|
7.7%
2/26
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.3%
1/77
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.6%
2/77
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/77
|
3.8%
1/26
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.9%
3/77
|
3.8%
1/26
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
1.3%
1/77
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
1.3%
1/77
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.9%
3/77
|
7.7%
2/26
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/77
|
11.5%
3/26
|
|
Vascular disorders
Hypotension
|
0.00%
0/77
|
3.8%
1/26
|
Other adverse events
| Measure |
E7389 28 Day Cycle
n=77 participants at risk
E7389 1.4 mg/m\^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
|
E7389 21 Day Cycle
n=26 participants at risk
E7389 1.4 mg/m\^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
6.5%
5/77
|
11.5%
3/26
|
|
Blood and lymphatic system disorders
Neutropenia
|
57.1%
44/77
|
53.8%
14/26
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.9%
3/77
|
7.7%
2/26
|
|
Cardiac disorders
Atrial Fibrillation
|
1.3%
1/77
|
7.7%
2/26
|
|
Cardiac disorders
Tachycardia
|
6.5%
5/77
|
0.00%
0/26
|
|
Gastrointestinal disorders
Abdominal Pain
|
13.0%
10/77
|
0.00%
0/26
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.2%
4/77
|
0.00%
0/26
|
|
Gastrointestinal disorders
Constipation
|
39.0%
30/77
|
57.7%
15/26
|
|
Gastrointestinal disorders
Diarrhea
|
24.7%
19/77
|
34.6%
9/26
|
|
Gastrointestinal disorders
Dry Mouth
|
6.5%
5/77
|
0.00%
0/26
|
|
Gastrointestinal disorders
Dysphagia
|
3.9%
3/77
|
7.7%
2/26
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
6/77
|
0.00%
0/26
|
|
Gastrointestinal disorders
Nausea
|
49.4%
38/77
|
50.0%
13/26
|
|
Gastrointestinal disorders
Stomatitis
|
18.2%
14/77
|
3.8%
1/26
|
|
Gastrointestinal disorders
Vomiting
|
31.2%
24/77
|
23.1%
6/26
|
|
General disorders
Asthenia
|
16.9%
13/77
|
15.4%
4/26
|
|
General disorders
Chest Pain
|
10.4%
8/77
|
15.4%
4/26
|
|
General disorders
Chills
|
9.1%
7/77
|
53.8%
14/26
|
|
General disorders
Fatigue
|
64.9%
50/77
|
57.7%
15/26
|
|
General disorders
Gait Disturbance
|
5.2%
4/77
|
0.00%
0/26
|
|
General disorders
Mucosal Inflammation
|
14.3%
11/77
|
7.7%
2/26
|
|
General disorders
Edema
|
9.1%
7/77
|
7.7%
2/26
|
|
General disorders
Edema Peripheral
|
19.5%
15/77
|
26.9%
7/26
|
|
General disorders
Pain
|
6.5%
5/77
|
11.5%
3/26
|
|
General disorders
Pyrexia
|
31.2%
24/77
|
23.1%
6/26
|
|
Infections and infestations
Bronchitis
|
1.3%
1/77
|
7.7%
2/26
|
|
Infections and infestations
Candidiasis
|
6.5%
5/77
|
3.8%
1/26
|
|
Infections and infestations
Herpes Zoster
|
1.3%
1/77
|
11.5%
3/26
|
|
Infections and infestations
Oral Candidiasis
|
6.5%
5/77
|
0.00%
0/26
|
|
Infections and infestations
Pneumonia
|
9.1%
7/77
|
7.7%
2/26
|
|
Infections and infestations
Sinusitis
|
10.4%
8/77
|
3.8%
1/26
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
13.0%
10/77
|
19.2%
5/26
|
|
Infections and infestations
Urinary Tract Infection
|
15.6%
12/77
|
11.5%
3/26
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.2%
4/77
|
0.00%
0/26
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/77
|
7.7%
2/26
|
|
Investigations
Breath Sounds Abnormal
|
13.0%
10/77
|
7.7%
2/26
|
|
Investigations
Weight Decreased
|
15.6%
12/77
|
7.7%
2/26
|
|
Metabolism and nutrition disorders
Anorexia
|
39.0%
30/77
|
42.3%
11/26
|
|
Gastrointestinal disorders
Decreased Appetite
|
3.9%
3/77
|
7.7%
2/26
|
|
Metabolism and nutrition disorders
Dehydration
|
13.0%
10/77
|
7.7%
2/26
|
|
Gastrointestinal disorders
Hyperglycemia
|
10.4%
8/77
|
3.8%
1/26
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.5%
5/77
|
3.8%
1/26
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.8%
6/77
|
7.7%
2/26
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.3%
1/77
|
11.5%
3/26
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.8%
16/77
|
3.8%
1/26
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.7%
9/77
|
19.2%
5/26
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
14.3%
11/77
|
15.4%
4/26
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
3.9%
3/77
|
7.7%
2/26
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
9.1%
7/77
|
7.7%
2/26
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
5.2%
4/77
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
7.8%
6/77
|
3.8%
1/26
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.2%
4/77
|
3.8%
1/26
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
9.1%
7/77
|
11.5%
3/26
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
6.5%
5/77
|
7.7%
2/26
|
|
Nervous system disorders
Dizziness
|
14.3%
11/77
|
26.9%
7/26
|
|
Nervous system disorders
Dysgeusia
|
2.6%
2/77
|
7.7%
2/26
|
|
Nervous system disorders
Headache
|
9.1%
7/77
|
7.7%
2/26
|
|
Nervous system disorders
Hypoaesthesia
|
6.5%
5/77
|
7.7%
2/26
|
|
Nervous system disorders
Neuropathy
|
14.3%
11/77
|
15.4%
4/26
|
|
Nervous system disorders
Neuropathy Peripheral
|
15.6%
12/77
|
15.4%
4/26
|
|
Nervous system disorders
Paraesthesia
|
5.2%
4/77
|
3.8%
1/26
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
9.1%
7/77
|
15.4%
4/26
|
|
Nervous system disorders
Somnolence
|
6.5%
5/77
|
3.8%
1/26
|
|
Psychiatric disorders
Anxiety
|
19.5%
15/77
|
19.2%
5/26
|
|
Psychiatric disorders
Confusional State
|
7.8%
6/77
|
0.00%
0/26
|
|
Psychiatric disorders
Depression
|
23.4%
18/77
|
11.5%
3/26
|
|
Psychiatric disorders
Insomnia
|
20.8%
16/77
|
15.4%
4/26
|
|
Renal and urinary disorders
Pollakiuria
|
7.8%
6/77
|
7.7%
2/26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.1%
27/77
|
23.1%
6/26
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.5%
5/77
|
7.7%
2/26
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
48.1%
37/77
|
46.2%
12/26
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea Exertional
|
5.2%
4/77
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.2%
4/77
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
5.2%
4/77
|
3.8%
1/26
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.5%
5/77
|
3.8%
1/26
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
9.1%
7/77
|
3.8%
1/26
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.6%
2/77
|
7.7%
2/26
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
5.2%
4/77
|
7.7%
2/26
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
1.3%
1/77
|
7.7%
2/26
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.9%
3/77
|
7.7%
2/26
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
1.3%
1/77
|
11.5%
3/26
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.5%
5/77
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
5.2%
4/77
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
13.0%
10/77
|
11.5%
3/26
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
44.2%
34/77
|
15.4%
4/26
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
6.5%
5/77
|
3.8%
1/26
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
11/77
|
11.5%
3/26
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.3%
1/77
|
11.5%
3/26
|
|
Vascular disorders
Hypotension
|
9.1%
7/77
|
3.8%
1/26
|
|
Vascular disorders
Phlebitis
|
2.6%
2/77
|
7.7%
2/26
|
Additional Information
Dr. Peter Tarassoff
Eisai
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place