NCT03810976

Brief Summary

The eribulin, a microtubule-dynamics inhibitor was approved for specific subtypes of STS. Eribulin demonstrated significantly better OS compared to dacarbazine in previously treated patients with liposarcoma and leiomyosarcoma and approved as standard treatment. However, the median progression free survival (PFS) and response rate (RR) was similar for both groups which remains modest outcome of 2.6 months of PFS and 4% of RR. Therefore, to improve antitumor activity, further combination strategy is strongly warranted. Based on the previous studies, investigators suggest phase II trial of eribulin and gemcitabine combination in previously treated patients with unresectable, advanced, or metastatic leiomyosarcoma or liposarcoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

4.2 years

First QC Date

January 16, 2019

Last Update Submit

June 14, 2022

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    To evaluate antitumor efficacy of eribulin and gemcitabine combination

    12 weeks

Secondary Outcomes (1)

  • adverse event

    through study completion, an average of 6 months

Study Arms (1)

eribulin+gemcitabine

EXPERIMENTAL

The dose is 1.4 mg/m2 for 5 minutes intravenously. If necessary, the dose may be diluted in up to 100 mL of saline solution prior to intravenous administration. Gemcitabine doses 1000 mg/m2 intravenously for 30 minutes. After completion of the eribulin injection, intravenously inject gemcitabine. One cycle is 3 weeks, and the treatment is carried out on the 1st day and the 8th day for each cycle.

Drug: Eribulin, gemcitabine

Interventions

Eribulin, gemcitabineDRUG

Elibulin 1.4mg/m2 Intravenous for 5minutes. Day 1\& Day 8 every 3 weeks Gemcitabine 1000mg/m2 intraveoust for 30 minutes, Day 1\& Day 8 every 3 weeks

eribulin+gemcitabine

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed advanced liposarcoma or leiomyosarcoma with 1-2 prior chemotherapy including anthracycline (unless contraindicated)
  • ECOG performance status of 0-2
  • Measurable or evaluable disease (RECIST 1.1.)
  • Adequate laboratory findings
  • Hb ≥ 9.0 g/dL
  • Absolute neutrophil count ≥ 1000 /µL
  • Platelet ≥ 75,000/ µL
  • Total Bilirubin: ≤ 1.5 × UNL (upper normal limit) (≤ 2 × UNL in patients with liver metastasis)
  • Serum Creatinine: ≤1.5 X upper limit of normal (ULN) OR ≥ Creatinine Clearance 60 mL/min (Cockcroft-Gault) for patients with creatinine levels \> 1.5 X institutional ULN
  • AST(SGOT)/ALT(SGPT): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver metastasis)
  • Alkaline Phosphatase : ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver or bone metastasis)
  • Prothrombin time and partial thromboplastin time : ≤1.5 X ULN
  • Female patient of childbearing potential has a negative serum or urine pregnancy test within 72 hours prior

You may not qualify if:

  • More than 3 prior cytotoxic agents
  • Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study
  • Uncontrolled or active CNS metastasis and/or carcinomatous meningitis
  • Patient has known hypersensitivity to the components of study drugs or its analogs.
  • Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
  • Long QT Syndrome ≥480 ms
  • peripheral neuropathy ≥2 with previous treatment
  • unstable cardiovascular disease
  • Symptomatic interstitial lung disease (ILD) or presence of ILD on chest X-ray

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Sarcoma

Interventions

eribulinGemcitabine

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 16, 2019

First Posted

January 22, 2019

Study Start

March 27, 2018

Primary Completion

May 30, 2022

Study Completion

May 30, 2022

Last Updated

June 16, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)