A study to evaluatethe safety and efficacy of eribulin in combination with gemcitabine in previously treated patients with advanced Liposarcoma or Leimyosarcoma.

Open-label, Phase II Trial of Eribulin in Combination With Gemcitabine in Previously Treated Patients with Advanced Liposarcoma or Leiomyosarcoma.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003547

Enrollment

Registered

2019-02-22

Start date

2018-03-20

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Patient with metastatic/ recurrent liposarcoma and Leisarcoma who had previously one or two chemotherapy with eeibuline and gemcitabine is repeated untile the disease progression. Syringe the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed advanced liposarcoma or leiomyosarcoma with 1-2 prior chemotherapy including anthracycline (unless contraindicated) : neoadjuvnat or adjuvant chemotherapy is counted as one regimen 2. ECOG(Eastern Cooperative Oncology Group) performance status of 0-2 3. Measurable or evaluable disease (RECIST 1.1.) 4. Adequate laboratory findings - Hemoglobin = 9.0 g/dL - Absolute neutrophil count (ANC) = 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 (ALP): = 3.0 × UNL or = 5.0 × UNL (in patients with liver or bone metastasis) - Prothrombin time and partial thromboplastin time (PTT) : =1.5 X ULN 5.Female patient of childbearing potential has a negative serum or urine pregnancy test within 72 hours prior

Exclusion criteria

Exclusion criteria: 1. More than 3 prior cytotoxic agents 2. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study 3. Uncontrolled or active CNS(Central nervous system) metastasis and/or carcinomatous meningitis 4. Patient has known hypersensitivity to the components of study drugs or its analogs. 5. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study. 6. Long QT Syndrome =480 ms 7. peripheral neuropathy =2 with previous treatment 8. unstable cardiovascular disease 9. Symptomatic interstitial lung disease (ILD) or presence of ILD on chest X-ray

Design outcomes

Primary

Measure	Time frame
Progression free survival rate at 12 weeks	—

Secondary

Measure	Time frame
Adverse event	—

Countries

Korea, Republic of

Contacts

Public ContactSunmi Song

Yonsei University Health System, Severance Hospital

smsong@yuhs.ac+82-2-2228-8048

Outcome results