Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
|ClinicalTrials.gov Identifier: NCT01327885|
Recruitment Status : Completed
First Posted : April 4, 2011
Results First Posted : February 28, 2017
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||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||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||452 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma|
|Study Start Date :||March 2011|
|Primary Completion Date :||January 2015|
|Study Completion Date :||August 2016|
|Experimental: Arm A||
Drug: Eribulin mesylate 1.4 mg/m^2 intravenous
Administration of eribulin mesylate at a dose of 1.4 mg/m^2 as an intravenous (IV) bolus infusion over 2-5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days.
|Active Comparator: Arm B||
Drug: Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV
Administration of dacarbazine at a dose of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 selected by the Principal Investigator [PI] or designee according to the subject's clinical status as an IV infusion over 15-30 minutes on Day 1 of every cycle, where the duration of each cycle is 21 days.
- Overall Survival (OS) [ Time Frame: From date of treatment start until date of death from any cause, assessed up to data cutoff date (02 Jan 2015), for up to approximately 3 years 11 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 (ADI or 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 >2 prior regimens).
- Progression-Free Survival (PFS) [ Time Frame: Randomization (day 1) to the date of first documentation of disease progression, or date of death (whichever occurred first) ]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).
- Progression-Free Rate at 12 Weeks (PFR12wks) [ Time Frame: From date of treatment 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.
- Clinical Benefit Rate (CBR) [ 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, or up to data cutoff (02 Jan 2015), for up to approximately 3 years 11 months ]CBR was defined as the percentage of participants who have best overall response (BOR) of CR, or 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327885
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