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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03058406
Other study ID # E7389-M081-503
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2016
Est. completion date November 4, 2018

Study information

Verified date August 2018
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to understand safety and efficacy in participants with soft tissue sarcomas.


Recruitment information / eligibility

Status Completed
Enrollment 256
Est. completion date November 4, 2018
Est. primary completion date November 4, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Participants with soft tissue sarcoma who will receive eribulin mesylate per the approved indication in routine clinical practice

Exclusion Criteria:

- None

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Eribulin mesylate
Participants will receive 1.4 milligrams per square meter (mg/m2) administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle and beyond.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Adverse Events (AEs) and Adverse Drug Reactions (ADRs) up to 2 years
Secondary Survival Rate at Year 2 up to 2 years
See also
  Status Clinical Trial Phase
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Completed NCT00289809 - TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients Phase 1/Phase 2
Completed NCT00243685 - Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis Phase 2/Phase 3
Active, not recruiting NCT01185964 - A Study of IMC-3G3 in Soft Tissue Sarcoma Phase 1/Phase 2
Completed NCT00753688 - Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy Phase 3
Completed NCT00187174 - Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors Phase 1
Completed NCT00093080 - Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED) Phase 2
Completed NCT03798795 - Radiomics for Tumor Grading of Soft Tissue Sarcomas.
Terminated NCT02929394 - Trabectedin Maintenance Post 1st-line in STS Phase 3
Recruiting NCT02275286 - Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients Phase 1/Phase 2
Completed NCT00406601 - BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas Phase 2
Completed NCT00297258 - Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma Phase 2
Active, not recruiting NCT06114173 - Efficacy and Safety Study of Cardunilizumab in Soft Tissue Sarcoma Early Phase 1
Completed NCT00061659 - Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Phase 2
Recruiting NCT03815474 - Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Soft Tissue Sarcoma Patients Phase 2
Recruiting NCT02812654 - Ifosfamide, Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Sarcoma Treatment Phase 2
Completed NCT00204620 - Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS) Phase 2
Active, not recruiting NCT02415816 - Diffusion Weighted Magnetic Resonance in Imaging Younger Patients With Newly Diagnosed Bone or Soft Tissue Sarcomas N/A
Withdrawn NCT02367651 - Study of Pazopanib Versus Placebo as Maintenance Therapy for Advanced Soft Tissue Sarcoma Phase 2