Phase II Study Of E7389, Halichondrin B Analogue, In Pati... | NCT00100932

Status Module

Label	Type	Description	Intervention Names
1	Experimental	E7389 28 day cycle	Drug: E7389 28 Day Cycle
2	Experimental	E7389 21 day cycle	Drug: E7389 21 Day Cycle

Name	Type	Description	Arm Group Labels	Other Names
E7389 28 Day Cycle	Drug	E7389 1.4 mg/m^2 IV bolus on Days 1, 8, and 15 of a 28 day cycle.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Objective Response Rate (ORR)	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).	From start of treatment until disease progression or recurrence

Secondary Outcomes

Measure	Description	Time Frame
Duration of Response	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.	From time of CR or PR until recurrence or progressive disease
Progression Free Survival

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

Patients must have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer with at least one site of measurable disease by the RECIST criteria.
Patients must have failed prior platinum-containing doublet chemotherapy. Patients who have received single agent chemotherapy with or without a subsequent taxane containing regimen may be enrolled after discussion with Sponsor.
Patients must be ≥ 18 years of age.
Patients must have a performance score of 0 or 1 using the ECOG performance scale.
Patients must have a life expectancy of ≥ 3 months.
Patients must have adequate renal function as evidenced by a serum creatinine ≤ 2.0 mg/dL or a calculated creatinine clearance ≥ 40 mL/min per the Cockcroft and Gault formula.
Patients must have adequate hepatic function as evidenced by bilirubin ≤1.5 mg/dL and alkaline phosphatase, AST and ALT ≤ 3 times upper limit of normal, unless there is evidence of liver metastases, in which case the alkaline phosphatase, AST and ALT must be ≤ 5 times upper limit of normal.
Patients must have adequate bone marrow function as evidenced by absolute neutrophil counts (ANC) ≥ 1.5 X 10^9/L, hemoglobin ≥ 10.0 g/dL (a hemoglobin < 10.0 g/dL would be acceptable if it can be corrected by growth factor or transfusion), and platelet count ≥ 100 X 10^9/L.
Patients must be willing and able to comply with the protocol guidelines for the duration of the study.
Patients must be willing and able to complete the Lung Cancer Symptom Scale (LCSS) instrument.
The biopsy specimen (paraffin block or at least 10 unstained slides) must be available from either the initial diagnosis or any subsequent diagnostic or surgical procedure of patients participating in the pharmacogenomics sub-study only. However, no additional biopsies are obligatory for participation in this study except those required for confirmation of the diagnosis.
Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.

EXCLUSION CRITERIA:

Patients with pre-existing peripheral neuropathy > Grade 2
Patients who require therapeutic doses of warfarin
Patients who have not recovered from any chemotherapy, radiation or other therapy related toxicity deemed to be clinically significant at study entry
Patients with active symptomatic brain metastases. Patients with central nervous system (CNS) metastases are considered eligible if they have had adequately treated brain metastases, i.e. have completed treatment (tapered off steroids) at least four weeks before starting treatment with E7389. Patients who have no evidence that the metastases are symptomatic or actively growing (no evidence of midline shift on CT scan or MRI) may be enrolled without initiation of local therapy for the CNS metastases. In this case, a repeat scan must be performed within four weeks of the original scan to ensure that disease progression is not occurring. It is not the intention of this study to treat patients with active brain metastases.
Patients who have a positive history for HIV, active hepatitis B or active hepatitis C.
Patients with other significant medical, or psychiatric disorders that, in the opinion of the investigator, will exclude the patient from the study for compliance or safety reasons
Patients who have received investigational drugs, including immunotherapy, gene therapy, hormone therapy (except megestrol acetate for appetite stimulation), or other biological therapy; conventional chemotherapy or radiation therapy (except for palliation, defined as less than 10% of the bone marrow reserve and less than 20 Gy), within three weeks of E7839 enrollment
Patients who have received non-cytotoxics (eg, gefitinib, erlotinib) within one week of E7389 enrollment
Patients who have not recovered from major surgery within three weeks of E7389 enrollment
Patients with severe/uncontrolled intercurrent illness/infection
Patients with significant cardiovascular impairment (history of congestive heart failure>NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia)
Patients with organ allografts
Patients with hypersensitivity to halichondrin B and/or halichondrin B-related compounds
Patients who participated in a prior E7389 clinical trial
Patients with second malignancy within the past 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma of the skin
Women who are pregnant or breast-feeding; woman of childbearing potential with a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months or using adequate contraception to be considered of non-childbearing potential.
Fertile men who are not willing to use contraception or fertile men with a female partner who is not willing to use contraception

Name	Affiliation	Role
Dale Shuster, Ph.D.	Eisai Inc.	Study Director

ID	Title	Description
FG000	E7389 28 Day Cycle	E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
FG001	E7389 21 Day Cycle	E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.

ID	Title	Description
BG000	E7389 28 Day Cycle	E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
BG001	E7389 21 Day Cycle	E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00077 BG00126 BG002103

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Objective Response Rate (ORR)

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).

Intent to Treat/Safety Population

Posted

Number

percentage of participants

From start of treatment until disease progression or recurrence

ID	Title	Description
OG000	E7389 28 Day Cycle	E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
OG001	E7389 21 Day Cycle	E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.

Units	Counts
Participants	OG00077 OG00126

Title

Denominators

Categories

Title	Measurements
	OG00011.7 OG0013.8

Secondary

Duration of Response

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.

Intent to Treat/Safety Population

Posted

Median

Full Range

Days

From time of CR or PR until recurrence or progressive disease

ID	Title	Description
OG000	E7389 28 Day Cycle	E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
OG001	E7389 21 Day Cycle	E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.

Units	Counts
Participants	OG000

Secondary

Progression Free Survival

Defined as the time from the start of study medication until progressive disease or death from any cause during the study period.

Intent to Treat/Safety Population

Posted

Median

Full Range

Days

From start of study medication until progressive disease or death

ID	Title	Description
OG000	E7389 28 Day Cycle	E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
OG001	E7389 21 Day Cycle	E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.

Units	Counts
Participants	OG000

Secondary

Overall Survival

Defined as the time from the start of study medication until death from any cause.

Not Posted

From time of start of study medication until death

Serious Adverse Events

Term	Organ System	Statistical Information
Febrile Neutropenia	Blood and lymphatic system disorders	EG0002 affected77 at risk EG0011 affected26 at risk
Neutropenia	Blood and lymphatic system disorders	EG0001 affected77 at risk EG0011 affected26 at risk
Pancytopenia	Blood and lymphatic system disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Cardiac Tamponade	Cardiac disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Abdominal Pain	Gastrointestinal disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Constipation	Gastrointestinal disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Diarrhea	Gastrointestinal disorders	EG0002 affected77 at risk EG0010 affected26 at risk
Diverticular Perforation	Gastrointestinal disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Gastritis	Gastrointestinal disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Nausea	Gastrointestinal disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Stomatitis	Gastrointestinal disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Vomiting	Gastrointestinal disorders	EG0001 affected77 at risk EG0011 affected26 at risk
Asthenia	General disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Chest Pain	General disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Disease Progression	General disorders	EG0005 affected77 at risk EG0010 affected26 at risk
Pain	General disorders	EG0002 affected77 at risk EG0011 affected26 at risk
Pyrexia	General disorders	EG0003 affected77 at risk EG0010 affected26 at risk
Cellulitis	Infections and infestations	EG0000 affected77 at risk EG0011 affected26 at risk
Neutropenic Sepsis	Infections and infestations	EG0001 affected77 at risk EG0010 affected26 at risk
Pneumonia	Infections and infestations	EG0003 affected77 at risk EG0011 affected26 at risk
Pyrothorax	Infections and infestations	EG0001 affected77 at risk EG0010 affected26 at risk
Sepsis	Infections and infestations	EG0001 affected77 at risk EG0010 affected26 at risk
Blood Pressure Systolic Inspiratory Decreased	Investigations	EG0000 affected77 at risk EG0011 affected26 at risk
Dehydration	Metabolism and nutrition disorders	EG0002 affected77 at risk EG0010 affected26 at risk
Hyponatremia	Metabolism and nutrition disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Malignant Neoplasm Progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0004 affected77 at risk EG0010 affected26 at risk
Metastases to Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected77 at risk EG0010 affected26 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected77 at risk EG0010 affected26 at risk
Coordination Abnormal	Nervous system disorders	EG0001 affected77 at risk EG0011 affected26 at risk
Dysarthria	Nervous system disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Neuropathy Peripheral	Nervous system disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Status Epilepticus	Nervous system disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Hallucinations, Visual	Psychiatric disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Mental Status Changes	Psychiatric disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	EG0003 affected77 at risk EG0012 affected26 at risk
Hemoptysis	Respiratory, thoracic and mediastinal disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	EG0002 affected77 at risk EG0010 affected26 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	EG0000 affected77 at risk EG0011 affected26 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	EG0003 affected77 at risk EG0011 affected26 at risk
Respiratory Arrest	Respiratory, thoracic and mediastinal disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	EG0001 affected77 at risk EG0010 affected26 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	EG0003 affected77 at risk EG0012 affected26 at risk
Deep Vein Thrombosis	Vascular disorders	EG0000 affected77 at risk EG0013 affected26 at risk
Hypotension	Vascular disorders	EG0000 affected77 at risk EG0011 affected26 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Leukopenia	Blood and lymphatic system disorders	EG0005 affected77 at risk EG0013 affected26 at risk
Neutropenia	Blood and lymphatic system disorders	EG00044 affected77 at risk EG00114 affected26 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG0003 affected77 at risk EG0012 affected26 at risk
Atrial Fibrillation	Cardiac disorders	EG0001 affected77 at risk EG0012 affected26 at risk
Tachycardia	Cardiac disorders	EG0005 affected77 at risk EG0010 affected26 at risk
Abdominal Pain	Gastrointestinal disorders	EG00010 affected77 at risk EG0010 affected26 at risk
Abdominal Pain Upper	Gastrointestinal disorders	EG0004 affected77 at risk EG0010 affected26 at risk
Constipation	Gastrointestinal disorders	EG00030 affected77 at risk EG00115 affected26 at risk
Diarrhea	Gastrointestinal disorders	EG00019 affected77 at risk EG0019 affected26 at risk
Dry Mouth	Gastrointestinal disorders	EG0005 affected77 at risk EG0010 affected26 at risk
Dysphagia	Gastrointestinal disorders	EG0003 affected77 at risk EG0012 affected26 at risk
Dyspepsia	Gastrointestinal disorders	EG0006 affected77 at risk EG0010 affected26 at risk
Nausea	Gastrointestinal disorders	EG00038 affected77 at risk EG00113 affected26 at risk
Stomatitis	Gastrointestinal disorders	EG00014 affected77 at risk EG0011 affected26 at risk
Vomiting	Gastrointestinal disorders	EG00024 affected77 at risk EG0016 affected26 at risk
Asthenia	General disorders	EG00013 affected77 at risk EG0014 affected26 at risk
Chest Pain	General disorders	EG0008 affected77 at risk EG0014 affected26 at risk
Chills	General disorders	EG0007 affected77 at risk EG00114 affected26 at risk
Fatigue	General disorders	EG00050 affected77 at risk EG00115 affected26 at risk
Gait Disturbance	General disorders	EG0004 affected77 at risk EG0010 affected26 at risk
Mucosal Inflammation	General disorders	EG00011 affected77 at risk EG0012 affected26 at risk
Edema	General disorders	EG0007 affected77 at risk EG0012 affected26 at risk
Edema Peripheral	General disorders	EG00015 affected77 at risk EG0017 affected26 at risk
Pain	General disorders	EG0005 affected77 at risk EG0013 affected26 at risk
Pyrexia	General disorders	EG00024 affected77 at risk EG0016 affected26 at risk
Bronchitis	Infections and infestations	EG0001 affected77 at risk EG0012 affected26 at risk
Candidiasis	Infections and infestations	EG0005 affected77 at risk EG0011 affected26 at risk
Herpes Zoster	Infections and infestations	EG0001 affected77 at risk EG0013 affected26 at risk
Oral Candidiasis	Infections and infestations	EG0005 affected77 at risk EG0010 affected26 at risk
Pneumonia	Infections and infestations	EG0007 affected77 at risk EG0012 affected26 at risk
Sinusitis	Infections and infestations	EG0008 affected77 at risk EG0011 affected26 at risk
Upper Respiratory Tract Infection	Infections and infestations	EG00010 affected77 at risk EG0015 affected26 at risk
Urinary Tract Infection	Infections and infestations	EG00012 affected77 at risk EG0013 affected26 at risk
Excoriation	Injury, poisoning and procedural complications	EG0004 affected77 at risk EG0010 affected26 at risk
Alanine Aminotransferase Increased	Investigations	EG0000 affected77 at risk EG0012 affected26 at risk
Breath Sounds Abnormal	Investigations	EG00010 affected77 at risk EG0012 affected26 at risk
Weight Decreased	Investigations	EG00012 affected77 at risk EG0012 affected26 at risk
Anorexia	Metabolism and nutrition disorders	EG00030 affected77 at risk EG00111 affected26 at risk
Decreased Appetite	Gastrointestinal disorders	EG0003 affected77 at risk EG0012 affected26 at risk
Dehydration	Metabolism and nutrition disorders	EG00010 affected77 at risk EG0012 affected26 at risk
Hyperglycemia	Gastrointestinal disorders	EG0008 affected77 at risk EG0011 affected26 at risk
Hypokalemia	Metabolism and nutrition disorders	EG0005 affected77 at risk EG0011 affected26 at risk
Hypomagnesemia	Metabolism and nutrition disorders	EG0006 affected77 at risk EG0012 affected26 at risk
Hyponatremia	Metabolism and nutrition disorders	EG0001 affected77 at risk EG0013 affected26 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG00016 affected77 at risk EG0011 affected26 at risk
Back Pain	Musculoskeletal and connective tissue disorders	EG0009 affected77 at risk EG0015 affected26 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	EG00011 affected77 at risk EG0014 affected26 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	EG0003 affected77 at risk EG0012 affected26 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	EG0007 affected77 at risk EG0012 affected26 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	EG0004 affected77 at risk EG0010 affected26 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	EG0006 affected77 at risk EG0011 affected26 at risk
Myalgia	Musculoskeletal and connective tissue disorders	EG0004 affected77 at risk EG0011 affected26 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	EG0007 affected77 at risk EG0013 affected26 at risk
Shoulder Pain	Musculoskeletal and connective tissue disorders	EG0005 affected77 at risk EG0012 affected26 at risk
Dizziness	Nervous system disorders	EG00011 affected77 at risk EG0017 affected26 at risk
Dysgeusia	Nervous system disorders	EG0002 affected77 at risk EG0012 affected26 at risk
Headache	Nervous system disorders	EG0007 affected77 at risk EG0012 affected26 at risk
Hypoaesthesia	Nervous system disorders	EG0005 affected77 at risk EG0012 affected26 at risk
Neuropathy	Nervous system disorders	EG00011 affected77 at risk EG0014 affected26 at risk
Neuropathy Peripheral	Nervous system disorders	EG00012 affected77 at risk EG0014 affected26 at risk
Paraesthesia	Nervous system disorders	EG0004 affected77 at risk EG0011 affected26 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	EG0007 affected77 at risk EG0014 affected26 at risk
Somnolence	Nervous system disorders	EG0005 affected77 at risk EG0011 affected26 at risk
Anxiety	Psychiatric disorders	EG00015 affected77 at risk EG0015 affected26 at risk
Confusional State	Psychiatric disorders	EG0006 affected77 at risk EG0010 affected26 at risk
Depression	Psychiatric disorders	EG00018 affected77 at risk EG0013 affected26 at risk
Insomnia	Psychiatric disorders	EG00016 affected77 at risk EG0014 affected26 at risk
Pollakiuria	Renal and urinary disorders	EG0006 affected77 at risk EG0012 affected26 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG00027 affected77 at risk EG0016 affected26 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	EG0005 affected77 at risk EG0012 affected26 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	EG00037 affected77 at risk EG00112 affected26 at risk
Dyspnea Exertional	Respiratory, thoracic and mediastinal disorders	EG0004 affected77 at risk EG0010 affected26 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	EG0004 affected77 at risk EG0010 affected26 at risk
Hemoptysis	Respiratory, thoracic and mediastinal disorders	EG0004 affected77 at risk EG0011 affected26 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	EG0005 affected77 at risk EG0011 affected26 at risk
Pharyngolaryngeal Pain	Respiratory, thoracic and mediastinal disorders	EG0007 affected77 at risk EG0011 affected26 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	EG0002 affected77 at risk EG0012 affected26 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	EG0004 affected77 at risk EG0012 affected26 at risk
Rales	Respiratory, thoracic and mediastinal disorders	EG0001 affected77 at risk EG0012 affected26 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	EG0003 affected77 at risk EG0012 affected26 at risk
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	EG0001 affected77 at risk EG0013 affected26 at risk
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	EG0005 affected77 at risk EG0010 affected26 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	EG0004 affected77 at risk EG0010 affected26 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	EG00010 affected77 at risk EG0013 affected26 at risk
Alopecia	Skin and subcutaneous tissue disorders	EG00034 affected77 at risk EG0014 affected26 at risk
Night Sweats	Skin and subcutaneous tissue disorders	EG0005 affected77 at risk EG0011 affected26 at risk
Rash	Skin and subcutaneous tissue disorders	EG00011 affected77 at risk EG0013 affected26 at risk
Deep Vein Thrombosis	Vascular disorders	EG0001 affected77 at risk EG0013 affected26 at risk
Hypotension	Vascular disorders	EG0007 affected77 at risk EG0011 affected26 at risk
Phlebitis	Vascular disorders	EG0002 affected77 at risk EG0012 affected26 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Gilroy	California		United States

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	E7389 28 Day Cycle	E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.			33	77	77	77
EG001	E7389 21 Day Cycle	E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.			11	26	26	26