6 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…
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…
1. To evaluate and optimalize a 3 Tesla MR protocol for the determination of the lipid composition of abdominal adipose tissue; by means of spectroscopy. 2.Determination of the reproducibility of MR-spectroscopy of abdominal adipose tissue. Both…
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…
- To assess the safety and tolerability of FSH-GEX* following multiple dose administration by subcutaneous injection- To determine the pharmacokinetic profile of FSH-GEX* following multiple dose administration by subcutaneous injection- To assess…
- To assess the safety and (local) tolerability of test compound following single rising dose administration by subcutaneous injection- To determine FSH pharmacokinetic parameters including Cmax and AUC0-last of test compound following single rising…