TriangleNCT01327885 · STUDY IN CONTEXT
Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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).
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).
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.
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.
Reported safety
Quality of life and patient-reported measures
FACT · Overall Survival (OS)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- qol key
- qol-0000
- source section id
- NCT01327885-om-0000
- source outcome index
- 0
- instrument
- FACT
- instrument basis
- matched 'factors' in the study's own wording
- scale title
- Overall Survival (OS)
- measure definition
- 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
- analysis role
- primary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- trial label
- Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 4
- harms Count
- 2
- qol Count
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- outcome key
- om-0000
- source section id
- NCT01327885-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival (OS)
- endpoint definition
- 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 origin
- From date of treatment start until date of death from any cause, up to 5 years 5 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- outcome key
- om-0001
- source section id
- NCT01327885-om-0001
- source outcome index
- 1
- endpoint
- Progression-Free Survival (PFS)
- endpoint definition
- 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 origin
- 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
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS (ITT analysis set) included all participants who were randomized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- outcome key
- om-0002
- source section id
- NCT01327885-om-0002
- source outcome index
- 2
- endpoint
- Progression-Free Rate at 12 Weeks (PFR12wks)
- endpoint definition
- 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 origin
- From date of randomization start until Week 12
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS (ITT analysis set) included all participants who were randomized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- outcome key
- om-0003
- source section id
- NCT01327885-om-0003
- source outcome index
- 3
- endpoint
- Clinical Benefit Rate (CBR)
- endpoint definition
- 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 origin
- 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
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS (ITT analysis set) included all participants who were randomized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A: Eribulin Mesylate
- regimen
- 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.
- analyzed count
- 228
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01327885-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B: Dacarbazine
- regimen
- 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.
- analyzed count
- 224
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01327885-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm A: Eribulin Mesylate
- regimen
- 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.
- analyzed count
- 228
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01327885-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm B: Dacarbazine
- regimen
- 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.
- analyzed count
- 224
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01327885-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A: Eribulin Mesylate
- regimen
- 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.
- analyzed count
- 228
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01327885-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm B: Dacarbazine
- regimen
- 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.
- analyzed count
- 224
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01327885-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm A: Eribulin Mesylate
- regimen
- 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.
- analyzed count
- 228
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01327885-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm B: Dacarbazine
- regimen
- 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.
- analyzed count
- 224
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01327885-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- harm key
- EG000
- source section id
- NCT01327885-ae
- event group key
- EG000
- event group label
- Arm A: Eribulin Mesylate
- serious affected
- 76
- serious at risk
- 228
- other affected
- 224
- other at risk
- 228
- frequency threshold
- 5
- collection period
- From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- harm key
- EG001
- source section id
- NCT01327885-ae
- event group key
- EG001
- event group label
- Arm B: Dacarbazine
- serious affected
- 71
- serious at risk
- 224
- other affected
- 218
- other at risk
- 224
- frequency threshold
- 5
- collection period
- From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT01327885
- qol key
- qol-0000
- source section id
- NCT01327885-om-0000
- source outcome index
- 0
- instrument
- FACT
- instrument basis
- matched 'factors' in the study's own wording
- scale title
- Overall Survival (OS)
- measure definition
- 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
- analysis role
- primary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice