5 results
The key objective of the study is to prove that trabectedin (Yondelis) and PLD prolong overall survival versus carboplatin + PLD, in patients with progressive ovarian cancer 6 to 12 months after completing previous platinum based chemotherapy.As…
Phase IIb: To evaluate the most effective dosing schedule of trabectedin.Phase III: To evaluate whether trabectedin given as 1st line chemothearpy for advanced/metastatic soft tissue sarcoma prolongs progression free surivival, as compared to…
The objective of the study is to investigate whether trabectedin demonstrates sufficient antitumor activity against recurrent grade II or III to justify further investigation in phase III or as adjuvant therapy for newly diagnosed disease after…
Part 1PrimaryTo assess dose limiting toxicities (DLTs) of EDR to select an RP3D for the combination to be used in Part 2 of this study.Secondary• To evaluate the overall safety profile of EDR to select an RP3D for the combination to be used in Part…
Dose Expansion:Primary Objective-*To investigate the antitumor activity of HE3-DXdSecondary Objectives-*To assess the safety and tolerability of HE3-DXd in metastatic or unresectable NSCLC subjects-*To characterize the PK of HE3-DXd, total anti-HER3…