Trial Outcomes & Findings for E7389 Administered as an IV Bolus Infusion Day 1 and Day 8 Every 3 Weeks in Pre-Treated Patients With Advanced and/or Metastatic Soft Tissue Sarcoma (NCT NCT00413192)

Last Updated: 2017-04-26

Results Overview

PFS was determined from the Week 12 visit tumor scan and the participant's date of death. Progression was defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), early death from any cause, or not assessable according to Response Evaluation Criteria In Solid Tumors (RECIST). CR defined as the loss of all target lesions. PR defined as ≥ 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. PD defined as ≥ 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of new lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since treatment started. The number and percentage of successes were summarized by stratum and overall, together with 95% 2-sided confidence intervals (CIs) for the percentage of successes.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

128 participants

Primary outcome timeframe

Week 12

Results posted on

2017-04-26

Participant Flow

A total of 128 participants were enrolled. Of these 128 participants115 were eligible to continue in the study following reassessment of study eligibility in which 12 participants previously found eligible and began treatment, were then assessed as ineligible. One participant was not treated.

Participant milestones

Participant milestones
Measure	Adipocyte Tumors (ADI) Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Leiomyosarcoma (LMS) Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Synovial Sarcoma (SYN) Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Other Types of Sarcoma (OTH) Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Overall Study STARTED	37	40	19	32
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	37	40	19	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Adipocyte Tumors (ADI) Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Leiomyosarcoma (LMS) Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Synovial Sarcoma (SYN) Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Other Types of Sarcoma (OTH) Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Overall Study Disease progression	26	31	16	25
Overall Study Toxicity	3	2	2	2
Overall Study Withdrawal by Subject	3	5	0	1
Overall Study Intercurrent illness	0	0	0	1
Overall Study Intercurrent death	0	1	0	0
Overall Study Other	5	1	1	2
Overall Study Not treated	0	0	0	1

Baseline Characteristics

E7389 Administered as an IV Bolus Infusion Day 1 and Day 8 Every 3 Weeks in Pre-Treated Patients With Advanced and/or Metastatic Soft Tissue Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adipocyte Tumors (ADI) n=37 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Leiomyosarcoma (LMS) n=40 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Synovial Sarcoma (SYN) n=19 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Other Types of Sarcoma (OTH) n=31 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Total n=127 Participants Total of all reporting groups
Age, Continuous	55.1 Years STANDARD_DEVIATION 11.35 • n=5 Participants	59.9 Years STANDARD_DEVIATION 12.69 • n=7 Participants	43.7 Years STANDARD_DEVIATION 17.92 • n=5 Participants	53.1 Years STANDARD_DEVIATION 15.21 • n=4 Participants	54.4 Years STANDARD_DEVIATION 14.66 • n=21 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	32 Participants n=7 Participants	5 Participants n=5 Participants	18 Participants n=4 Participants	66 Participants n=21 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants	13 Participants n=4 Participants	61 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Efficacy evaluable set (EES) consisted of all registered, eligible subjects who had received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Adipocyte Tumors (ADI) n=32 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Leiomyosarcoma (LMS) n=38 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Synovial Sarcoma (SYN) n=19 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Other Types of Sarcoma (OTH) n=26 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Progression Free Survival (PFS) at 12 Weeks	46.9 Percentage of participants Interval 29.1 to 65.3	31.6 Percentage of participants Interval 17.5 to 48.7	21.1 Percentage of participants Interval 6.1 to 45.6	19.2 Percentage of participants Interval 6.6 to 39.4

SECONDARY outcome

Timeframe: First dose of study drug to the date of disease progression or date of death, whichever occurs first, or date of study cut-off 28 Jun 2012, up to 5.5 years

Population: EES

Overall PFS was determined from any evidence that the participant had progressed, along with whether or not the participant was still alive at the end of the study. Tumors were evaluated every 6 weeks during treatment, and at least 4 weeks after the first observation of a complete or partial response. After discontinuation of study drug, participants without PD were re-evaluated every 12 weeks, unless a new anticancer therapy was started. Participants were considered as having progressed if they were classed as PD at Week 12, or had a best overall response (BOR) of PD, or had a date of progression, if they discontinued due to PD, died due to PD, or if the PI had recorded a date of progression. A participant was determined progression free if they were alive without PD at the time of study cut-off. The number and percentage of successes were summarized by stratum and overall, together with 95% 2-sided CIs for the percentage of successes.

Outcome measures

Outcome measures
Measure	Adipocyte Tumors (ADI) n=32 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Leiomyosarcoma (LMS) n=38 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Synovial Sarcoma (SYN) n=19 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Other Types of Sarcoma (OTH) n=26 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Overall Progression Free Survival	82 Days Interval 44.0 to 175.0	88 Days Interval 69.0 to 114.0	81 Days Interval 43.0 to 101.0	72 Days Interval 42.0 to 87.0

SECONDARY outcome

Timeframe: Date of first dose of study drug until documentation of CR or PR, or up to data cutoff 28 Jun 2012, up to approximately 5.5 years

Population: EES

ORR was defined as the percentage of participants in the analysis set who had a BOR of CR or PR based on RECIST v. 1.0 for target lesions. Tumors were assessed using x-rays, magnetic resonance imaging (MRI), or computed tomography (CT) scans, or both, as appropriate. ORR was documented and confirmed by two measurements taken at least 4 weeks apart. CR was defined as the disappearance of all target lesions. PR defined as ≥ 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Best overall response was derived using the same hierarchy as used when determining the PFS status at Week 12. No adjustments were made for participants who started further anticancer therapy prior to disease progression. 95% CIs were calculated using the exact method of binomial distribution. ORR = CR + PR

Outcome measures

Outcome measures
Measure	Adipocyte Tumors (ADI) n=32 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Leiomyosarcoma (LMS) n=38 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Synovial Sarcoma (SYN) n=19 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Other Types of Sarcoma (OTH) n=26 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Objective Response Rate (ORR)	3.1 Percentage of participants Interval 0.1 to 16.2	5.3 Percentage of participants Interval 0.6 to 17.7	5.3 Percentage of participants Interval 0.1 to 26.0	3.8 Percentage of participants Interval 0.1 to 19.6

SECONDARY outcome

Timeframe: Date of first dose of study drug to documentation of CR, PR, or SD, or until data cutoff date 28 Jun 2012, up to approximately 5.5 years

Population: EES

CRB was defined as the percentage of participants with a BOR of CR or PR or SD as defined by RECIST, described previously. BOR was derived using the same hierarchy as used when determining the status at Week 12. No adjustments were made for participants who started further anticancer therapy prior to disease progression. 95% CIs were calculated using the exact method of binomial distribution. CRB = CR + PR + SD

Outcome measures

Outcome measures
Measure	Adipocyte Tumors (ADI) n=32 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Leiomyosarcoma (LMS) n=38 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Synovial Sarcoma (SYN) n=19 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Other Types of Sarcoma (OTH) n=26 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Clinical Response Benefit (CRB)	59.4 Percentage of participants Interval 40.6 to 76.3	57.9 Percentage of participants Interval 40.8 to 73.7	47.4 Percentage of participants Interval 24.4 to 71.1	46.2 Percentage of participants Interval 26.6 to 66.6

SECONDARY outcome

Timeframe: Date of first dose of study drug to date of first documented CR or PR, or until data cutoff date 28 Jun 2012, up to approximately 5.5 years

Population: EES

Time to onset of response could be calculated only if a participant achieved an objective response (BOR of CR or PR as defined previously). Participants who never achieved CR or PR were not included in the Kaplan-Meier survival estimates for the time to onset of response by strata. Given the small number of participants with these responses and the large variation in time to onset of response between participants, no comparison could be made among the strata.

Outcome measures

Outcome measures
Measure	Adipocyte Tumors (ADI) n=32 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Leiomyosarcoma (LMS) n=38 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Synovial Sarcoma (SYN) n=19 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Other Types of Sarcoma (OTH) n=26 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Time to Onset of Response	86 Days Not calculable (n=1)	166 Days Interval 120.0 to 211.0	77 Days Not calculable (n=1)	42 Days Not calculable (n=1)

SECONDARY outcome

Timeframe: Date of first documented CR or PR until the date of first document disease progression (or death), or up to data cutoff 28 Jun 2012, up to approximately 5.5 years

Population: EES

Duration of response could be calculated only if a participant achieved a BOR of CR or PR, as defined previously. For consistency with the formula used by the European Organization for Research and Treatment of Cancer (EORTC), the duration was derived as "day of event minus day of first documented CR or PR" (one was not added to the calculation). Participants who were alive without documented progression had their duration of response censored at the day of last follow-up for progression. Participants who never achieved CR or PR were not included in the Kaplan-Meier survival estimates for the duration of response by strata. No adjustment was made for participants who started further anticancer therapy prior to disease progression.

Outcome measures

Outcome measures
Measure	Adipocyte Tumors (ADI) n=32 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Leiomyosarcoma (LMS) n=38 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Synovial Sarcoma (SYN) n=19 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Other Types of Sarcoma (OTH) n=26 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Duration of Response	418 Days Not calculable (n=1)	129 Days Interval 85.0 to 173.0	102 Days Not calculable (n=1)	85 Days Not calculable (n=1)

SECONDARY outcome

Timeframe: Date of first dose of study drug to date of death from any cause, or up to cut-off date of 28 Jun 2012, up to approximately 5.5 years

Population: EES

Participants still alive at the end of the study had their time to event censored at the day last known to be alive. Participants lost to follow-up were also censored at the date last known to be alive. 95% CIs for the percentage of participants still alive at the end of the study were presented as described for the primary endpoint, PFS at Week 12.

Outcome measures

Outcome measures
Measure	Adipocyte Tumors (ADI) n=32 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Leiomyosarcoma (LMS) n=38 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Synovial Sarcoma (SYN) n=19 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Other Types of Sarcoma (OTH) n=26 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Overall Survival (OS)	363 Days Interval 234.0 to 495.0	466 Days Interval 392.0 to 697.0	293 Days Interval 170.0 to 371.0	204 Days Interval 149.0 to 312.0

SECONDARY outcome

Timeframe: Day 1 of study treatment until progressive disease, or up to cut-off date of 28 Jun 2012, up to approximately 5.5 years

Population: Safety analysis set included all participants who received at least one dose of study drug, regardless of their eligibility to enter the study.

Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. TEAEs are defined as an adverse event (AE) that emerged during treatment, having been absent at baseline or: reemerged during treatment, having been present at pretreatment (baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. All AEs and SAEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. A participant was counted only once within a System Organ Class (SOC) and preferred term (PT), even if the participant experienced more than one TEAE with a specific SOC and PT. Participants were summarized by treatment group according to the worst CTCAE grade assigned for each PT. Treatment-related TEAEs included TEAEs that were considered by the investigator to be possibly or probably related to study drug or TEAEs with a missing relationship.

Outcome measures

Outcome measures
Measure	Adipocyte Tumors (ADI) n=37 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Leiomyosarcoma (LMS) n=40 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Synovial Sarcoma (SYN) n=19 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.	Other Types of Sarcoma (OTH) n=31 Participants Participants were administered 1.4 mg/m\^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
Summary of Adverse Events (AEs) TEAEs	97.3 Percentage of participants	95.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants
Summary of Adverse Events (AEs) Treatment-related TEAEs	94.6 Percentage of participants	87.5 Percentage of participants	94.7 Percentage of participants	83.9 Percentage of participants
Summary of Adverse Events (AEs) TEAEs with CTCAE Grade 3 or 4	54.1 Percentage of participants	45.0 Percentage of participants	47.4 Percentage of participants	58.1 Percentage of participants
Summary of Adverse Events (AEs) Serious TEAEs	37.8 Percentage of participants	30.0 Percentage of participants	36.8 Percentage of participants	45.2 Percentage of participants
Summary of Adverse Events (AEs) TEAEs leading to death	2.7 Percentage of participants	5.0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

Adverse Events

Adipocyte Tumors (ADI)

Serious events: 14 serious events

Other events: 36 other events

Deaths: 0 deaths

Leiomyosarcoma (LMS)

Serious events: 12 serious events

Other events: 38 other events

Deaths: 0 deaths

Synovial Sarcoma (SYN)

Serious events: 7 serious events

Other events: 19 other events

Deaths: 0 deaths

Other Types of Sarcoma (OTH)

Serious events: 14 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Gitta Irmer Associate Director, Data Quality & Standards Global Regulatory Operations

Eisai Ltd. Mosquito Way, Hatfield, Hertfordshire, AL 10 9SN

Phone: +44 (0) 845 676 1618

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER