8 results
The primary objective of this study is• To assess the efficacy of vilaprisan in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are• To assess the efficacy of vilaprisan in subjects with uterine fibroids…
Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of intra-operative blood-loss (primary outcome), surgical time, surgical ease, complications, quality of life and costs.
The purpose of the study is to determine whether treatment with alpelisib in combination with olaparib can delay the time to cancer progression compared to standard-of-care chemotherapy in participants with your type of ovarian cancer known as…
Primary:Long-term safety of nivolumab in participants on treatment and in follow upExploratory:To follow participants who have completed therapy and are in or have completed follow-up on a parent study investigating nivolumab or nivolumab…
Evaluate the (cost-) effectiveness of ulipristal in comparison with standard surgical treatment for symptomatic uterine fibroids, measured by the symptom severity score of the Uterine Fibroid Symptoms questionnaire (UFS-QOL), a validated Quality of…
Primary ObjectivesSafety run-in Part 1:To confirm the recommended dose of alpelisib in combination with trastuzumab and pertuzumab for Part 2.Double-blind, randomized, placebo-controlled Part 2:To determine whether treatment with alpelisib in…
In the current phase 2 study we will investigate the efficacy of the combination of fulvestrant and alpelisib directly after progression on 1st or 2nd line therapy with fulvestrant with or without a CDK 4/6 inhibitor in patients with HR+HER2-…
Primary objective:* To demonstrate the efficacy of alpelisib as measured by the proportion of participants randomized to alpelisib with a response at Week 24 in at least one of the following groups:* Group 1 (>= 18 yr-old)* Group 2 (6 - 17 yr…