10 results
Primary objective of the study is• To investigate efficacy and safety of different oraldoses of BAY94-8862 given once daily over 90 daysThe secondary objectives are:•To assess the effects of these doses on a compositeendpoint of death from any cause…
The primary objective of the study is to demonstrate the superiority of the combination BAY 60 4552 / vardenafil over vardenafil alone in the treatment of erectile dysfunction not sufficiently responsive to standard therapy with PDE5 inhibitors.The…
zie study protocol
The primary objective of the study is to determine the MTD (Maximally Tolerated Dose) of SGN-40 from among three possible dose levels when combined with a standard dose of bortezomib and to determine the safety and adverse event profile for…
To characterize the exposure-response relationship of MVT-602 effects on luteinizing hormone (LH) concentrations after subcutaneous administration of single 0.1 to 3 µg doses of MVT-602 or placebo in healthy premenopausal women undergoing COS to…
That patients who have had clinical response or clinical remission after use with Risankizumab can continue using Risankizumab. Also long term safety of Risankizumab will be assessed in patients who were diagnosed with moderate to severe Crohn'…
Primary objective:To observe an increase in Overall Response Rate (ORR) from 20% in the pembrolizumab alone arm to 50% in the pembrolizumab after SBRT arm at 12 weeks. Secondary Objective: - Disease Control Rate, defined as the percentage of…
The primary objectives for the study are: Cohort 1, to characterize cardiac safety of different Daratumumab, cyclophosphamide, bortezomib, and dexamethasone (D-VCd) treatment regimens (Arm A: immediate daratumumab + VCd treatment and Arm B:…
Primary: To characterize the safety and tolerability of LXH254 single agent and to identify recommended doses for future studies in adult patients with advanced solid tumors harboring MAPK pathway alterations.To characterize the safety and…
The primary objective of this study is to compare the efficacy of teclistamab monotherapy (Arm A) with that of an investigator*s choice of PVd or Kd (Arm B: termed PVd/Kd hereafter) as assessed by PFS.