Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT01327885

Recruitment Status : Completed

First Posted : April 4, 2011

Results First Posted : February 28, 2017

Last Update Posted : July 29, 2020

Sponsor:

Information provided by (Responsible Party):

Eisai Inc.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Soft Tissue Sarcoma
Interventions	Drug: Eribulin mesylate 1.4 mg/m^2 intravenous Drug: Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV
Enrollment	452

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Arm A: Eribulin Mesylate	Arm B: Dacarbazine
Arm/Group Description	Eribulin mesylate at a dose of 1.4 ...	Dacarbazine at a dose of 850 mg/m^2...
Arm/Group Description	Eribulin mesylate at a dose of 1.4 milligram per square meter (mg/m^2) was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.	Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
Period Title: Overall Study
Started	228	224
Completed	0	0
Not Completed	228	224
Reason Not Completed
Disease progression-according to RECIST	173	165
Clinical progression	24	27
Adverse Event	14	10
Subject choice	5	10
Other	8	6
Withdrawal of consent from study	3	4
Not treated	1	1
Administrative decision	0	1

Baseline Characteristics

Arm/Group Title		Arm A: Eribulin Mesylate	Arm B: Dacarbazine	Total
Arm/Group Description		Eribulin mesylate at a dose of 1.4 ...	Dacarbazine at a dose of 850 mg/m^2...	Total of all reporting groups
Arm/Group Description		Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.	Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.	Total of all reporting groups
Overall Number of Baseline Participants		228	224	452
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.
Age, Continuous Geometric Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	228 participants	224 participants	452 participants
		55.6 (11.01)	55.7 (10.35)	55.7 (10.68)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	228 participants	224 participants	452 participants
	Female	161 70.6%	142 63.4%	303 67.0%
	Male	67 29.4%	82 36.6%	149 33.0%

Outcome Measures

1.Primary Outcome


Title	Overall Survival (OS)
Description	OS was defined as the time in months from the date of treatment start ...
Description	OS was defined as the time in months from the date of treatment start until death, regardless of cause. In the absence of confirmation of death, participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. Participants who died on the date of randomization had a survival time of 0.5 day. Allocation of randomization numbers were performed based upon the following stratification factors: (a) Histology (adipocytic [ADI] or leiomyosarcoma [LMS]), (b) Region (Region 1: USA and Canada; or Region 2: Western Europe, Australia, Israel; or Region 3: Eastern Europe, Latin America, and Asia), and (c) Number of prior regimens for advanced soft tissue sarcoma (STS) (2 or greater than [>] 2 prior regimens).
Time Frame	From date of treatment start until date of death from any cause, up to 5 years 5 months

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.


Arm/Group Title	Arm A: Eribulin Mesylate	Arm B: Dacarbazine
Arm/Group Description:	Eribulin mesylate at a dose of 1.4 ...	Dacarbazine at a dose of 850 mg/m^2...
Arm/Group Description:	Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.	Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
Overall Number of Participants Analyzed	228	224
Median (95% Confidence Interval) Unit of Measure: Months
	13.5 (10.9 to 15.6)	11.5 (9.6 to 13.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: Eribulin Mesylate, Arm B: Dacarbazine
	Comments	Statistical analysis was designed to detect superiority of Arm A (eribulin) over Arm B (dacarbazine). OS was compared between the two treatment arms using a two-sided stratified log-rank test at a nominal significance level of 0.0455 (adjusted for the interim analysis). This was the primary analysis that was performed when the target number of events (~353 deaths) was observed.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	=0.0169
	Comments	The P-value was calculated by 2-sided log-rank test as stratified by histology, geographic region, and number of prior regimens for advanced STS.
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.768
	Confidence Interval	(2-Sided) 95% 0.618 to 0.954
	Estimation Comments	The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.

2.Secondary Outcome


Title	Progression-Free Survival (PFS)
Description	PFS was defined as the time from the date of randomization to the date...
Description	PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death (whichever occurred first). The date of disease progression was defined as the date of radiologic disease progression as assessed by the investigator or designee based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Participants who did not have an event (i.e., participants who were lost to follow-up or who did not progress or die at the date of data cut-off), were censored. Participants who discontinued study treatment without disease progression were censored on the date of their last radiological assessment (scan date).
Time Frame	Randomization (day 1) to the date of first documentation of disease progression, or date of death (whichever occurred first), up to 5 years 5 months

Outcome Measure Data

Analysis Population Description

FAS (ITT analysis set) included all participants who were randomized.


Arm/Group Title	Arm A: Eribulin Mesylate	Arm B: Dacarbazine
Arm/Group Description:	Eribulin mesylate at a dose of 1.4 ...	Dacarbazine at a dose of 850 mg/m^2...
Arm/Group Description:	Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.	Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
Overall Number of Participants Analyzed	228	224
Median (95% Confidence Interval) Unit of Measure: Months
	2.6 (1.9 to 2.8)	2.6 (1.8 to 2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: Eribulin Mesylate, Arm B: Dacarbazine
	Comments	The PFS and PFS rate at 3, 6, and 12 months (95% confidence interval (CI)) was calculated using Kaplan-Meier (K-M) product-limit method and Greenwood Formula. PFS was compared between the treatment arms using two-sided stratified log-rank test, stratified by histology, geographic region, and number of prior regimens for advanced STS.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	=0.2287
	Comments	P-value was calculated by 2-sided log-rank test, as stratified by histology, geographic region, and number of prior regimens for advanced STS.
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.877
	Confidence Interval	(2-Sided) 95% 0.710 to 1.085
	Estimation Comments	The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.

3.Secondary Outcome


Title	Progression-Free Rate at 12 Weeks (PFR12wks)
Description	The PFR12wks was defined as the percentage of participants who were st...
Description	The PFR12wks was defined as the percentage of participants who were still alive without disease progression at 12 weeks from the date of randomization. Tumor assessment by the investigator or designee was based on RECIST criteria 1.1.
Time Frame	From date of randomization start until Week 12

Outcome Measure Data

Analysis Population Description

FAS (ITT analysis set) included all participants who were randomized.


Arm/Group Title	Arm A: Eribulin Mesylate	Arm B: Dacarbazine
Arm/Group Description:	Eribulin mesylate at a dose of 1.4 ...	Dacarbazine at a dose of 850 mg/m^2...
Arm/Group Description:	Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.	Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
Overall Number of Participants Analyzed	228	224
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of participants
	33.3 (27.2 to 39.9)	28.6 (22.8 to 35.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: Eribulin Mesylate, Arm B: Dacarbazine
	Comments	The PFR12wks was compared between the treatment arms using stratified Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.253
	Comments	The P-value was calculated using the stratified CMH method, the stratified factors included histology, geographic region, and number of prior regimens for advanced STS.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95% 0.8 to 1.9
	Estimation Comments	The odds ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of the odds ratio is based on asymptotic normal approximation.

4.Secondary Outcome


Title	Clinical Benefit Rate (CBR)
Description	CBR was defined as the percentage of participants who have best overal...
Description	CBR was defined as the percentage of participants who have best overall response (BOR) of complete response (CR), or partial response (PR), or duration of stable disease (dSD) greater than or equal to 11 weeks, between Arm A and Arm B. CBR was estimated by treatment arm based on the tumor response evaluation performed by the PI or designee according to RECIST 1.1. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter.
Time Frame	From date of treatment start (Day 1) until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, up to 5 years 5 months

Outcome Measure Data

Analysis Population Description

FAS (ITT analysis set) included all participants who were randomized.


Arm/Group Title	Arm A: Eribulin Mesylate	Arm B: Dacarbazine
Arm/Group Description:	Eribulin mesylate at a dose of 1.4 ...	Dacarbazine at a dose of 850 mg/m^2...
Arm/Group Description:	Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.	Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
Overall Number of Participants Analyzed	228	224
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of participants
	46.1 (39.5 to 52.8)	47.8 (41.1 to 54.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: Eribulin Mesylate, Arm B: Dacarbazine
	Comments	The PFR12wks was compared between the treatment arms using stratified CMH chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	=0.741
	Comments	The P-value was calculated using the CMH method. The stratified factors were histology, geographic region, and number of prior regimens for advanced STS.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95% 0.7 to 1.4
	Estimation Comments	The Odds Ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of Odds Ratio is based on asymptotic normal approximation.

Adverse Events

Time Frame	From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Arm A: Eribulin Mesylate	Arm B: Dacarbazine
Arm/Group Description	Eribulin mesylate at a dose of 1.4 ...	Dacarbazine at a dose of 850 mg/m^2...
Arm/Group Description	Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.	Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
All-Cause Mortality
	Arm A: Eribulin Mesylate	Arm B: Dacarbazine
	Affected / at Risk (%)	Affected / at Risk (%)
Total	198/228 (86.84%)	206/224 (91.96%)
Serious Adverse Events Serious Adverse Events
	Arm A: Eribulin Mesylate	Arm B: Dacarbazine
	Affected / at Risk (%)	Affected / at Risk (%)
Total	76/228 (33.33%)	71/224 (31.70%)
Blood and lymphatic system disorders
Neutropenia ^† 1	11/228 (4.82%)	10/224 (4.46%)
Anaemia ^† 1	5/228 (2.19%)	9/224 (4.02%)
Leukopenia ^† 1	3/228 (1.32%)	3/224 (1.34%)
Febrile neutropenia ^† 1	2/228 (0.88%)	2/224 (0.89%)
Lymphopenia ^† 1	1/228 (0.44%)	0/224 (0.00%)
Pancytopenia ^† 1	0/228 (0.00%)	3/224 (1.34%)
Thrombocytopenia ^† 1	0/228 (0.00%)	13/224 (5.80%)
Cardiac disorders
Atrial fibrillation ^† 1	1/228 (0.44%)	1/224 (0.45%)
Pericardial effusion ^† 1	1/228 (0.44%)	0/224 (0.00%)
Cardiac arrest ^† 1	0/228 (0.00%)	1/224 (0.45%)
Gastrointestinal disorders
Abdominal pain ^† 1	4/228 (1.75%)	4/224 (1.79%)
Intestinal obstruction ^† 1	4/228 (1.75%)	5/224 (2.23%)
Diarrhoea ^† 1	2/228 (0.88%)	2/224 (0.89%)
Small intestinal obstruction ^† 1	2/228 (0.88%)	3/224 (1.34%)
Constipation ^† 1	1/228 (0.44%)	0/224 (0.00%)
Ileus ^† 1	1/228 (0.44%)	0/224 (0.00%)
Intestinal ischaemia ^† 1	1/228 (0.44%)	0/224 (0.00%)
Large intestine perforation ^† 1	1/228 (0.44%)	0/224 (0.00%)
Oesophagitis ^† 1	1/228 (0.44%)	0/224 (0.00%)
Retroperitoneal haemorrhage ^† 1	1/228 (0.44%)	0/224 (0.00%)
Subileus ^† 1	1/228 (0.44%)	0/224 (0.00%)
Abdominal distension ^† 1	0/228 (0.00%)	1/224 (0.45%)
Abdominal pain upper ^† 1	0/228 (0.00%)	1/224 (0.45%)
Diverticulum ^† 1	0/228 (0.00%)	1/224 (0.45%)
Duodenal fistula ^† 1	0/228 (0.00%)	1/224 (0.45%)
Gastrointestinal haemorrhage ^† 1	0/228 (0.00%)	1/224 (0.45%)
Gastrointestinal ulcer haemorrhage ^† 1	0/228 (0.00%)	1/224 (0.45%)
Intestinal haemorrhage ^† 1	0/228 (0.00%)	1/224 (0.45%)
Large intestinal obstruction ^† 1	0/228 (0.00%)	1/224 (0.45%)
General disorders
Pyrexia ^† 1	10/228 (4.39%)	4/224 (1.79%)
Asthenia ^† 1	3/228 (1.32%)	1/224 (0.45%)
General physical health deterioration ^† 1	2/228 (0.88%)	1/224 (0.45%)
Fatigue ^† 1	1/228 (0.44%)	0/224 (0.00%)
Non-cardiac chest pain ^† 1	0/228 (0.00%)	1/224 (0.45%)
Hepatobiliary disorders
Hyperbilirubinaemia ^† 1	2/228 (0.88%)	0/224 (0.00%)
Biliary dilatation ^† 1	1/228 (0.44%)	0/224 (0.00%)
Hepatotoxicity ^† 1	1/228 (0.44%)	0/224 (0.00%)
Cholangitis ^† 1	0/228 (0.00%)	1/224 (0.45%)
Cholecystitis ^† 1	0/228 (0.00%)	1/224 (0.45%)
Immune system disorders
Hypersensitivity ^† 1	1/228 (0.44%)	0/224 (0.00%)
Drug hypersensitivity ^† 1	0/228 (0.00%)	1/224 (0.45%)
Infections and infestations
Urinary tract infection ^† 1	4/228 (1.75%)	1/224 (0.45%)
Pneumonia ^† 1	3/228 (1.32%)	2/224 (0.89%)
Lung infection ^† 1	2/228 (0.88%)	0/224 (0.00%)
Peritonitis bacterial ^† 1	2/228 (0.88%)	0/224 (0.00%)
Arthritis bacterial ^† 1	1/228 (0.44%)	0/224 (0.00%)
Bronchopneumonia ^† 1	1/228 (0.44%)	0/224 (0.00%)
Catheter site infection ^† 1	1/228 (0.44%)	0/224 (0.00%)
Device related infection ^† 1	1/228 (0.44%)	1/224 (0.45%)
Lower respiratory tract infection fungal ^† 1	1/228 (0.44%)	0/224 (0.00%)
Neutropenic sepsis ^† 1	1/228 (0.44%)	0/224 (0.00%)
Peritonitis ^† 1	1/228 (0.44%)	0/224 (0.00%)
Pseudomonal bacteraemia ^† 1	1/228 (0.44%)	0/224 (0.00%)
Pyelonephritis ^† 1	1/228 (0.44%)	0/224 (0.00%)
Septic shock ^† 1	1/228 (0.44%)	0/224 (0.00%)
Serratia bacteraemia ^† 1	1/228 (0.44%)	0/224 (0.00%)
Staphylococcal bacteraemia ^† 1	1/228 (0.44%)	0/224 (0.00%)
Staphylococcal infection ^† 1	1/228 (0.44%)	0/224 (0.00%)
Cellulitis ^† 1	0/228 (0.00%)	1/224 (0.45%)
Erysipelas ^† 1	0/228 (0.00%)	1/224 (0.45%)
Respiratory tract infection ^† 1	0/228 (0.00%)	1/224 (0.45%)
Vestibular neuronitis ^† 1	0/228 (0.00%)	1/224 (0.45%)
Injury, poisoning and procedural complications
Humerus fracture ^† 1	1/228 (0.44%)	0/224 (0.00%)
Post procedural haemorrhage ^† 1	1/228 (0.44%)	0/224 (0.00%)
Radiation pneumonitis ^† 1	1/228 (0.44%)	0/224 (0.00%)
Wound dehiscence ^† 1	1/228 (0.44%)	0/224 (0.00%)
Toxicity to various agents ^† 1	0/228 (0.00%)	1/224 (0.45%)
Investigations
Alanine aminotransferase increased ^† 1	1/228 (0.44%)	1/224 (0.45%)
Aspartate aminotransferase increased ^† 1	1/228 (0.44%)	1/224 (0.45%)
Electrocardiogram QT prolonged ^† 1	1/228 (0.44%)	0/224 (0.00%)
International normalised ratio increased ^† 1	1/228 (0.44%)	0/224 (0.00%)
Neutrophil count decreased ^† 1	1/228 (0.44%)	1/224 (0.45%)
White blood cell count decreased ^† 1	1/228 (0.44%)	0/224 (0.00%)
Haemoglobin decreased ^† 1	0/228 (0.00%)	2/224 (0.89%)
Platelet count decreased ^† 1	0/228 (0.00%)	1/224 (0.45%)
Metabolism and nutrition disorders
Hypokalaemia ^† 1	1/228 (0.44%)	0/224 (0.00%)
Hyponatraemia ^† 1	1/228 (0.44%)	0/224 (0.00%)
Hypophosphataemia ^† 1	1/228 (0.44%)	0/224 (0.00%)
Musculoskeletal and connective tissue disorders
Back pain ^† 1	2/228 (0.88%)	0/224 (0.00%)
Pathological fracture ^† 1	2/228 (0.88%)	1/224 (0.45%)
Musculoskeletal pain ^† 1	0/228 (0.00%)	1/224 (0.45%)
Spinal pain ^† 1	0/228 (0.00%)	1/224 (0.45%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain ^† 1	2/228 (0.88%)	0/224 (0.00%)
Metastases to bone ^† 1	1/228 (0.44%)	0/224 (0.00%)
Metastases to lung ^† 1	1/228 (0.44%)	1/224 (0.45%)
Metastases to neck ^† 1	1/228 (0.44%)	0/224 (0.00%)
Metastatic pain ^† 1	1/228 (0.44%)	0/224 (0.00%)
Myxoid liposarcoma ^† 1	1/228 (0.44%)	0/224 (0.00%)
Tumour associated fever ^† 1	1/228 (0.44%)	0/224 (0.00%)
Tumour haemorrhage ^† 1	1/228 (0.44%)	0/224 (0.00%)
Intracranial tumour haemorrhage ^† 1	0/228 (0.00%)	1/224 (0.45%)
Leiomyosarcoma ^† 1	0/228 (0.00%)	1/224 (0.45%)
Malignant ascites ^† 1	0/228 (0.00%)	1/224 (0.45%)
Malignant pleural effusion ^† 1	0/228 (0.00%)	2/224 (0.89%)
Tumour pain ^† 1	0/228 (0.00%)	1/224 (0.45%)
Nervous system disorders
Convulsion ^† 1	1/228 (0.44%)	0/224 (0.00%)
Monoplegia ^† 1	1/228 (0.44%)	0/224 (0.00%)
Spinal cord compression ^† 1	1/228 (0.44%)	0/224 (0.00%)
Neuralgia ^† 1	0/228 (0.00%)	1/224 (0.45%)
Peripheral motor neuropathy ^† 1	0/228 (0.00%)	1/224 (0.45%)
Renal and urinary disorders
Renal failure acute ^† 1	1/228 (0.44%)	1/224 (0.45%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism ^† 1	4/228 (1.75%)	1/224 (0.45%)
Respiratory failure ^† 1	4/228 (1.75%)	2/224 (0.89%)
Dyspnoea ^† 1	2/228 (0.88%)	4/224 (1.79%)
Acute respiratory failure ^† 1	1/228 (0.44%)	0/224 (0.00%)
Pneumonia aspiration ^† 1	1/228 (0.44%)	0/224 (0.00%)
Pneumothorax ^† 1	1/228 (0.44%)	1/224 (0.45%)
Atelectasis ^† 1	0/228 (0.00%)	1/224 (0.45%)
Dyspnoea exertional ^† 1	0/228 (0.00%)	1/224 (0.45%)
Epistaxis ^† 1	0/228 (0.00%)	1/224 (0.45%)
Hiccups ^† 1	0/228 (0.00%)	1/224 (0.45%)
Pleural effusion ^† 1	0/228 (0.00%)	2/224 (0.89%)
Vascular disorders
Superior vena cava syndrome ^† 1	1/228 (0.44%)	0/224 (0.00%)
Vena cava thrombosis ^† 1	1/228 (0.44%)	0/224 (0.00%)
Deep vein thrombosis ^† 1	0/228 (0.00%)	3/224 (1.34%)
Hypotension ^† 1	0/228 (0.00%)	2/224 (0.89%)
1 Term from vocabulary, MedDRA 17.1 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Arm A: Eribulin Mesylate	Arm B: Dacarbazine
	Affected / at Risk (%)	Affected / at Risk (%)
Total	224/228 (98.25%)	218/224 (97.32%)
Blood and lymphatic system disorders
Neutropenia ^† 1	95/228 (41.67%)	51/224 (22.77%)
Anaemia ^† 1	66/228 (28.95%)	68/224 (30.36%)
Thrombocytopenia ^† 1	13/228 (5.70%)	60/224 (26.79%)
Leukopenia ^† 1	36/228 (15.79%)	22/224 (9.82%)
Eye disorders
Lacrimation increased ^† 1	18/228 (7.89%)	1/224 (0.45%)
Gastrointestinal disorders
Nausea ^† 1	91/228 (39.91%)	106/224 (47.32%)
Constipation ^† 1	70/228 (30.70%)	58/224 (25.89%)
Abdominal pain ^† 1	42/228 (18.42%)	32/224 (14.29%)
Vomiting ^† 1	43/228 (18.86%)	50/224 (22.32%)
Diarrhoea ^† 1	38/228 (16.67%)	35/224 (15.63%)
Stomatitis ^† 1	31/228 (13.60%)	11/224 (4.91%)
Abdominal pain upper ^† 1	19/228 (8.33%)	13/224 (5.80%)
Dyspepsia ^† 1	18/228 (7.89%)	7/224 (3.13%)
Abdominal distension ^† 1	16/228 (7.02%)	12/224 (5.36%)
Dry mouth ^† 1	12/228 (5.26%)	4/224 (1.79%)
General disorders
Fatigue ^† 1	98/228 (42.98%)	86/224 (38.39%)
Pyrexia ^† 1	58/228 (25.44%)	28/224 (12.50%)
Asthenia ^† 1	46/228 (20.18%)	51/224 (22.77%)
Oedema peripheral ^† 1	27/228 (11.84%)	17/224 (7.59%)
Infections and infestations
Urinary tract infection ^† 1	23/228 (10.09%)	11/224 (4.91%)
Upper respiratory tract infection ^† 1	20/228 (8.77%)	9/224 (4.02%)
Investigations
Aspartate aminotransferase increased ^† 1	21/228 (9.21%)	5/224 (2.23%)
Neutrophil count decreased ^† 1	19/228 (8.33%)	12/224 (5.36%)
Alanine aminotransferase increased ^† 1	18/228 (7.89%)	8/224 (3.57%)
White blood cell count decreased ^† 1	16/228 (7.02%)	15/224 (6.70%)
Electrocardiogram QT prolonged ^† 1	14/228 (6.14%)	11/224 (4.91%)
Blood lactate dehydrogenase increased ^† 1	12/228 (5.26%)	7/224 (3.13%)
Platelet count decreased ^† 1	2/228 (0.88%)	17/224 (7.59%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	43/228 (18.86%)	43/224 (19.20%)
Hypokalaemia ^† 1	23/228 (10.09%)	9/224 (4.02%)
Hyperglycaemia ^† 1	17/228 (7.46%)	6/224 (2.68%)
Musculoskeletal and connective tissue disorders
Back pain ^† 1	33/228 (14.47%)	31/224 (13.84%)
Myalgia ^† 1	23/228 (10.09%)	17/224 (7.59%)
Pain in extremity ^† 1	20/228 (8.77%)	18/224 (8.04%)
Arthralgia ^† 1	19/228 (8.33%)	13/224 (5.80%)
Muscle spasms ^† 1	13/228 (5.70%)	7/224 (3.13%)
Musculoskeletal pain ^† 1	12/228 (5.26%)	11/224 (4.91%)
Nervous system disorders
Peripheral sensory neuropathy ^† 1	46/228 (20.18%)	8/224 (3.57%)
Headache ^† 1	41/228 (17.98%)	21/224 (9.38%)
Dizziness ^† 1	21/228 (9.21%)	16/224 (7.14%)
Paraesthesia ^† 1	20/228 (8.77%)	7/224 (3.13%)
Dysgeusia ^† 1	18/228 (7.89%)	5/224 (2.23%)
Psychiatric disorders
Insomnia ^† 1	22/228 (9.65%)	10/224 (4.46%)
Anxiety ^† 1	12/228 (5.26%)	14/224 (6.25%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	39/228 (17.11%)	28/224 (12.50%)
Dyspnoea ^† 1	34/228 (14.91%)	33/224 (14.73%)
Oropharyngeal pain ^† 1	12/228 (5.26%)	5/224 (2.23%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	79/228 (34.65%)	6/224 (2.68%)
Vascular disorders
Hypotension ^† 1	13/228 (5.70%)	4/224 (1.79%)
1 Term from vocabulary, MedDRA 17.1 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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

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Name/Title:	Eisai Medical Information
Organization:	Eisai Inc.
Phone:	1-888-274-2378
EMail:	esi_oncmedinfo@eisai.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schöffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, Blay JY, Hohenberger P, D'Adamo D, Guo M, Chmielowski B, Le Cesne A, Demetri GD, Patel SR. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016 Apr 16;387(10028):1629-37. doi: 10.1016/S0140-6736(15)01283-0. Epub 2016 Feb 10.

Layout table for additonal information

Responsible Party:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT01327885
Other Study ID Numbers:	E7389-G000-309 2010-024483-17 ( EudraCT Number )
First Submitted:	March 31, 2011
First Posted:	April 4, 2011
Results First Submitted:	January 6, 2017
Results First Posted:	February 28, 2017
Last Update Posted:	July 29, 2020

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