13 results
• To evaluate the effect of olaparib on exposure to anastrozole by determination of steady-state exposure to anastrozole in the presence and absence of steady-state exposure to olaparib• To evaluate the effect of anastrozole on exposure to olaparib…
To investigate prospectively how the "TAMRO-profile" performs in a pre-operative treatment setting. In addition we can examine whether the profile is specific for tamoxifen or is predictive for endocrine resistance in general. Also the…
The primary objective of Study I3Y-MC-JPBY (JPBY) is to compare the biological activity ofabemaciclib in combination with anastrozole, abemaciclib monotherapy, and anastrozole monotherapy byassessing the percentage change from the baseline value in…
Protocol section 2.1 and 2.2
To demonstrate that spesolimab is effective in maintaining Symptomatic Stenosis Responseand / or inducing Radiographic Stenosis Response (defined in Table 2.3: 1) in patients withsymptomatic CD-related small bowel stenosis, who have achieved…
The primary objective is to estimate the effect of spesolimab compared to placebo for the mean percent change from baseline in total abscessand inflammatory nodule count at Week 12. Secondary objectives are the evaluation of efficacy of spesolimab…
The primary objective of the study is to evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free…
The purpose of this study is to assess short-term and the long-term safety and efficacy of oral ZPL389 (30 mg once daily (o.d.) and 50 mg o.d.) when used concomitantly or intermittently with topical corticosteroid (TCS) and/or topical calcineurin…
The primary objective of Study I3Y-MC-JPBM is to compare treatment with LY2835219 plus NSAI therapy versus placebo plus NSAI therapy with respect to PFS in postmenopausal women with HR+, HER2- locoregionally recurrent or metastatic breast cancer who…
The primary objective of the trial is to demonstrate a non-flat curve and evaluate the doseresponse relationship for 3 subcutaneous dosing regimens of BI 655130 (spesolimab) (with each regimen consisting of a single loading dose and a separate…
Primary Objective: To determine the effect of sex hormones on bone marrow fat. and visceral fatSecondary Objective(s): * To determine the effect of sex hormones on visceral and liver fat.* To test whether DXA can be used to calculate the amount of…
To demonstrate superiority of giredestrant over the control treatment in preventing breast cancer recurrence.Secondary objectives• To evaluate the efficacy of giredestrant compared with TPC in terms of overall survival andother measures• To evaluate…
The primary objective of this trial is to assess the long-term safety of spesolimab in patients with HS who have completed the 1368-0052 PoCC trial and are qualified for entry into this trial. The secondary objectives are to evaluate efficacy at a…