Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication YONDELIS ® is indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen [see Clinical Studies (14) ] . YONDELIS is an alkylating drug indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen ( 1 ) FDA label
Also known as ET-743, Yondelis
trabectedin · 1 trial · 2 indications
safety will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.03
| Arm | Type | Description |
|---|---|---|
| Trabectedin plus olaparib | EXPERIMENTAL | All patients will be treated with trabectedin and olaparib in an open-label fashion. The dosage of the drugs at which each patient is treated depends on the dose level reached at the time of enrollment. |
| Name | Type | Description |
|---|---|---|
| trabectedin | DRUG | trabectedin will be administered in a 24-h continuous i.v. infusion every 3 weeks |
| olaparib | DRUG | olaparib will be administered in a continuous daily dose every 12 hours |
Inclusion Criteria: * written informed consent * histologically documented and not surgically resectable or metastatic sarcomas which progressed after first or further line treatments for relapsing disease * Measurable disease as defined by RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) P...