Status Approved
First Submitted Date
2019/01/11
Registered Date
2019/02/22
Last Updated Date
2019/02/11
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003547 |
---|---|
Unique Protocol ID | 4-2017-0933 |
Public/Brief Title | A study to evaluatethe safety and efficacy of eribulin in combination with gemcitabine in previously treated patients with advanced Liposarcoma or Leimyosarcoma. |
Scientific Title | Open-label, Phase II Trial of Eribulin in Combination With Gemcitabine in Previously Treated Patients with Advanced Liposarcoma or Leiomyosarcoma. |
Acronym | |
MFDS Regulated Study | Yes |
IND/IDE Protocol | Yes |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Submitted pending |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
---|---|
Board Approval Number | 4-2017-0933 |
Approval Date | 2017-11-22 |
Institutional Review Board Name | Yonsei University Health System, Severance Hospital, Institutional Review Board |
Institutional Review Board Address | 50-1, Yonsei-ro, Seodaemun-gu, Seoul |
Institutional Review Board Telephone | 02-2228-0435 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | Hyosong Kim |
Title | MD |
Telephone | +82-2-2228-8124 |
Affiliation | Yonsei University Health System, Severance Hospital |
Address | 50-1 Yonsei-ro, Seodaemun-gu, Seoul |
Contact Person for Public Queries | |
Name | Jeongrim Choo |
Title | CRC |
Telephone | +82-2-2228-8048 |
Affiliation | Yonsei University Health System, Severance Hospital |
Address | 50-1 Yonsei-ro, Seodaemun-gu, Seoul |
Contact Person for Updating Information | |
Name | Jeongrim Choo |
Title | CRC |
Telephone | +82-2-2228-8048 |
Affiliation | Yonsei University Health System, Severance Hospital |
Address | 50-1 Yonsei-ro, Seodaemun-gu, Seoul |
4. Status
Study Site | Multi-center Number of center : 3 | |
---|---|---|
Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2018-03-20 Actual | |
Target Number of Participant | 37 | |
Primary Completion Date | 2019-02-28 , Anticipated | |
Study Completion Date | 2019-08-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Yonsei University Health System, Severance Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2018-03-20 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Asan Medical Center | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2019-03-29 , | |
Recruitment Status by Participating Study Site 3 | ||
Name of Study | Samsung Medical Center | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2019-03-29 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Chong Kun Dang |
Organization Type | Pharmaceutical Company |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Yonsei University Health System, Severance Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay 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, we suggest phase II trial of eribulin and gemcitabine combination in previously treated patients with unresectable, advanced, or metastatic leiomyosarcoma or liposarcoma. |
---|
8. Study Design
Study Type | Interventional Study |
---|---|
Study Purpose | Treatment |
Phase | Phase2 |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Non-RCT |
Intervention Type | Drug |
Intervention Description | 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 required amount of eribulin from the appropriate number of vials. 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. |
Number of Arms | 1 |
Arm 1 |
Arm Label Eribulin, Gemcitabine |
Target Number of Participant 37 |
|
Arm Type Experimental |
|
Arm Description Elibulin 1.4mg/m2 Intravenous for 5minutes. Gemcitabine 1000mg/m2 intraveoust for 30 minutes. Day 1& Day 8 every 3 weeks. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C41.9)Malignant neoplasm of bone and articular cartilage, unspecified Liposarcoma or Leiomyosarcoma |
---|---|
Rare Disease | Yes |
Inclusion Criteria |
Gender Both |
Age 19Year~No Limit |
|
Description 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 |
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 |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Progression free survival rate at 12 weeks |
|
Timepoint | every 6weeks up to 12weeks : will be based on RECIST version 1.1 |
|
Secondary Outcome(s) 1 | ||
Outcome | Adverse event |
|
Timepoint | Every visit |
11. Study Results and Publication
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
---|
TOP
BOTTOM
화면 최하단으로 이동