Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Arm1- bevacizumab (Onbevzi) at a dose of 15 mg/kg administered as a 30-minute intravenous infusion on Day 1 of each 21-day cycle, followed by intravenous infusion of gemcitabine and docetaxel in sequence. On Day 8 of each cycle, gemcitabine and docetaxel will be administered as a 60-minute intravenous infusion.
Arm2- On Day 1 of each 21-day cycle, gemcitabine will be administered first, followed by docetaxel as an intravenous infusion. On Day 8, gemcitabine and docetaxel will be administered as intravenous infusions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bev + Gem + Doc | Experimental | bevacizumab (Onbevzi) at a dose of 15 mg/kg administered as a 30-minute intravenous infusion on Day 1 of each 21-day cycle, followed by intravenous infusion of gemcitabine and docetaxel in sequence. On Day 8 of each cycle, gemcitabine and docetaxel will be administered as a 60-minute intravenous infusion. |
|
| Gem + Doc | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bev + Gem + Doc | Drug | bevacizumab (Onbevzi) at a dose of 15 mg/kg administered as a 30-minute intravenous infusion on Day 1 of each 21-day cycle, followed by intravenous infusion of gemcitabine and docetaxel in sequence. On Day 8 of each cycle, gemcitabine and docetaxel will be administered as a 60-minute intravenous infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate, ORR | Overall response rate (ORR) based on RECIST version 1.1 | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | The earlier of the date of first documented progressive disease or death from the date of enrollment | 2 year |
| Overall survival (OS) | From the date of treatment initiation to the date of death or last follow-up |
Not provided
Inclusion Criteria:
Histologically confirmed advanced leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), liposarcoma, or angiosarcoma with 1-2 prior chemotherapy
: neoadjuvnat or adjuvant chemotherapy is counted as one regimen
Age ≥19 years, <80 years
ECOG performance status of 0-1
Has at least 1 measurable lesion (as defined by RECIST v1.1).
Has adequate organ function defined by the following criteria:
Female patient of childbearing potential has a negative serum or urine pregnancy test for β-hCG
Able to provide written informed consent and comply with the protocol requirements
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyo Song Kim, Professor | Contact | +82-2-2228-8123 | hyosong77@yuhs.ac |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003900 | Desoxycorticosterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Gem + Doc | Drug |
|
|
| 2 year |
| Safety profile | Safety profile assessed using CTCAE (version 5.0) | 2 year |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |