Trial · NCT01327885
Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
NCT01327885, Phase 3, Completed, Eisai Inc.; results first posted 2017-02-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma. Trials, record NCT01327885. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01327885
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
- NCT number
- NCT01327885
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 452 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Soft Tissue Sarcoma
- Interventions
- Eribulin mesylate 1.4 mg/m^2 intravenous, Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV
- First posted
- 2011-04-04
- Last updated
- 2023-06-22
- Other registries' IDs
- eudract:2010-024483-17
- Results first posted
- 2017-02-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From date of treatment start until date of death from any cause, up to 5 years 5 months | 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). |
| Secondary | Progression-Free Survival (PFS) | 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 | 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). |
| Secondary | Progression-Free Rate at 12 Weeks (PFR12wks) | From date of randomization start until Week 12 | 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. |
| Secondary | Clinical Benefit Rate (CBR) | 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 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From date of treatment start until date of death from any cause, up to 5 years 5 months | Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | 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 | FAS (ITT analysis set) included all participants who were randomized. | Months | MEDIAN |
| SECONDARY | Progression-Free Rate at 12 Weeks (PFR12wks) | From date of randomization start until Week 12 | FAS (ITT analysis set) included all participants who were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) | 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 | FAS (ITT analysis set) included all participants who were randomized. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Arm A: Eribulin Mesylate | 13.5 | 95% Confidence Interval 10.9 to 15.6 | Months | |
| Overall Survival (OS) | Arm B: Dacarbazine | 11.5 | 95% Confidence Interval 9.6 to 13.0 | Months | |
| Progression-Free Survival (PFS) | Arm A: Eribulin Mesylate | 2.6 | 95% Confidence Interval 1.9 to 2.8 | Months | |
| Progression-Free Survival (PFS) | Arm B: Dacarbazine | 2.6 | 95% Confidence Interval 1.8 to 2.7 | Months | |
| Progression-Free Rate at 12 Weeks (PFR12wks) | Arm A: Eribulin Mesylate | 33.3 | 95% Confidence Interval 27.2 to 39.9 | Percentage of participants | |
| Progression-Free Rate at 12 Weeks (PFR12wks) | Arm B: Dacarbazine | 28.6 | 95% Confidence Interval 22.8 to 35.0 | Percentage of participants | |
| Clinical Benefit Rate (CBR) | Arm A: Eribulin Mesylate | 46.1 | 95% Confidence Interval 39.5 to 52.8 | Percentage of participants | |
| Clinical Benefit Rate (CBR) | Arm B: Dacarbazine | 47.8 | 95% Confidence Interval 41.1 to 54.5 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Eribulin Mesylate | 228 | |
| Overall Study | STARTED | Arm B: Dacarbazine | 224 | |
| Overall Study | COMPLETED | Arm A: Eribulin Mesylate | 0 | |
| Overall Study | COMPLETED | Arm B: Dacarbazine | 0 | |
| Overall Study | NOT COMPLETED | Arm A: Eribulin Mesylate | 228 | |
| Overall Study | NOT COMPLETED | Arm B: Dacarbazine | 224 |
Source ClinicalTrials.gov
Adverse events330
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Arm A: Eribulin Mesylate | 95 | 228 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm B: Dacarbazine | 51 | 224 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm A: Eribulin Mesylate | 66 | 228 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Dacarbazine | 68 | 224 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm A: Eribulin Mesylate | 13 | 228 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm B: Dacarbazine | 60 | 224 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A: Eribulin Mesylate | 36 | 228 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm B: Dacarbazine | 22 | 224 | |
| other | Lacrimation increased | Eye disorders | Arm A: Eribulin Mesylate | 18 | 228 | |
| other | Lacrimation increased | Eye disorders | Arm B: Dacarbazine | 1 | 224 |
1 to 10 of 330Source ClinicalTrials.gov
See all 330 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Eribulin Mesylate | 198 | 228 |
| Total, all-cause mortality | Arm B: Dacarbazine | 206 | 224 |
| Total, other adverse events | Arm A: Eribulin Mesylate | 224 | 228 |
| Total, other adverse events | Arm B: Dacarbazine | 218 | 224 |
| Total, serious adverse events | Arm A: Eribulin Mesylate | 76 | 228 |
| Total, serious adverse events | Arm B: Dacarbazine | 71 | 224 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26874885 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Eribulin Mesylate vs Arm B: Dacarbazine: deaths from any cause | Trial comparisons |
| Arm A: Eribulin Mesylate vs Arm B: Dacarbazine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01327885
GET https://conductscience.org/api/trials/v1/NCT01327885/events?page=2