Clinical trial · Interventional
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 (Study E7389-J081-217)
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
NCT01458249CI-TRIAL-00021522completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eribulin mesylate | Drug | Eribulin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- eribulin mesylate 1.4 mg/m^2
- interventionNames
- Drug: eribulin mesylate
Primary outcomes (1)
- measure
- Progression-free Rate at 12 Weeks (PFR12wks)
- timeFrame
- Week 12
- description
- 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 (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria * Histologically or cytologically confirmed soft tissue sarcoma of high or intermediate grade * Documented evidence of advanced or metastatic soft tissue sarcoma, not amenable to surgery or radiotherapy * Within 6 months from the radiographic evidence of disease progression by RECIST criteria in the last chemotherapy regimen for advanced or metastatic soft tissue sarcoma * Presence of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Subjects who received at least one standard chemotherapy for advanced soft tissue sarcoma (an anthracycline or an ifosfamide monotherapy, or a combination therapy) * Subjects aged ≥ 20 years at the time of informed consent * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 * Adequate organ function * Voluntary agreement to provide written informed consent Exclusion Criteria * A history of malignancies or recurrence within 5 years after the remission * Significant cardiovascular impairment * Any serious concomitant illness or infection requiring treatment. * Hypersensitivity to either halichondrin B or halichondrin B chemical derivatives or both. * Subjects who have previously participated in a study with eribulin (whether treated with eribulin or not). * Any medical or other condition which, in the opinion of the principal investigator, will preclude participation in a clinical trial. * Subjects who have received any anti-cancer therapy, including surgery, radiotherapy, immunotherapy, cytotoxic, hormonal, biological (including humanized antibodies) and targeted agents within 21 days, or any investigational agent within 30 days, prior to the first dose of study drug. * Subjects who have not recovered from toxicities as a result of prior anti-cancer therapy to ≤ Grade 1, according to Common Terminology Criteria for Adverse Events (CTCAE), except for peripheral neuropathy of Grade 2 and alopecia. * Subjects with known cerebral metastases with clinical symptoms or requiring treatment. * Pre-existing peripheral neuropathy \> CTCAE Grade 2. * Female subjects must not be pregnant with a negative by the pregnancy test at Screening, or breastfeeding. * Subjects participating in other clinical trials
References
Publications (0)
Data not yet available
No reference posted for this study.