Status:
COMPLETED
A Study of Eribulin With Gemcitabine in Patients With Advanced Liposarcoma or Leiomyosarcoma
Lead Sponsor:
Yonsei University
Conditions:
Sarcoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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 lipo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03810976
Start Date
March 27 2018
End Date
May 30 2022
Last Update
June 16 2022
Active Locations (1)
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1
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722