An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Previously Treated Subjects With Advanced or Metastatic Soft Tissue Sarcoma
Overview
- Phase
- Phase 2
- Intervention
- eribulin mesylate
- Conditions
- Soft Tissue Sarcoma
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 52
- Primary Endpoint
- Progression-free Rate at 12 Weeks (PFR12wks)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of eribulin mesylate in subjects with soft tissue sarcoma who received at least one standard chemotherapy (an anthracycline or an ifosfamide monotherapy or a combination therapy).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
eribulin mesylate 1.4 mg/m^2
Intervention: eribulin mesylate
Outcomes
Primary Outcomes
Progression-free Rate at 12 Weeks (PFR12wks)
Time Frame: Week 12
The PFR at 12 weeks was the percentage of participants with progression-free survival (success) measured as a binary variable based on the tumor response assessed at Week 12 after the start of study treatment. Participants were considered a success if one radiological evaluation performed at least Week 12 after start of therapy indicated stable disease (SD), or complete response (CR) or partial response (PR), as defined according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1); all other cases were considered as failures (including disease progression or death before the Week 12 evaluation, or had unknown disease status at Week 12). If new anticancer treatments were started before the Week 12 evaluation, participants were considered failures. A 2-sided 90% confidence interval (CI) was calculated using the exact method of binomial distribution.
Secondary Outcomes
- Progression-Free Survival (PFS)(Cycle 1 (Day 1) to progressive disease (PD) or death, or date of study cutoff (14 Nov 2014) up to 3 years)
- Overall Survival (OS)(Cycle 1 (Day 1) to death, or date of study cutoff, (14 Nov 2014), up to 3 years)
- Objective Response Rate (ORR)(Date of CR or PR to the date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years)
- Disease Control Rate (DCR)(Date of CR, PR, or SD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years)
- Clinical Benefit Rate (CBR)(First dose of study treatment to the date of CR, PR, or dSD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years)
- Durable Stable Disease (SD) Rate (dSDR)(Date of dSD to date of PD or death, whichever is first, or date of study cutoff (24 Nov 2014), up to 3 years)
- Best Overall Response (BOR)(Date of CR, PR, SD to PD or death of any cause, whichever is first, or date of study cutoff (14 Nov 2014), or up to 3 years)