Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Yondelis · 1 trial · 2 indications
Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.
| Arm | Type | Description |
|---|---|---|
| Yondelis weekly schedule | EXPERIMENTAL | Yondelis weekly schedule: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1 8 and 15 of each 28-day treatment cycle. Patients will be pretreated with 10 mg of dexamethasone i.v. 30 minutes prior to each infusion. |
| Yondelis once every 3 weeks schedule | EXPERIMENTAL | Yondelis once every 3 weeks schedule: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. Patients will be pretreated with 20 mg of dexamethasone i.v. on Day 1 of each treatment cycle 30 minutes prior to each infusion. |
| Name | Type | Description |
|---|---|---|
| Yondelis | DRUG | 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. |
| Dexamethasone | DRUG | Pretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondelis infusion on Days 1, 8, and 15 of each 28-day treatment cycle. |
Inclusion Criteria: * Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread) * Have a pathology specimen available for centralized review * Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study,...
Yondelis is an investigational small molecule being studied for the treatment of liposarcoma, a type of soft tissue sarcoma. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Yondelis is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 2 clinical trials for liposarcoma.
Yondelis is in Phase 2 clinical development. It is an investigational drug being studied for the treatment of liposarcoma and has not yet been approved for commercial use.
Yondelis has been studied in one completed Phase 2 clinical trial, identified as NCT00060944. This trial assessed two different dosing schedules of trabectedin in patients with advanced cancer, including liposarcoma and leiomyosarcoma, and enrolled 271 participants.
Yondelis is also known as trabectedin. The clinical trial NCT00060944, which studied Yondelis, is titled 'A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer.'