9 results
To compare prostate-specific antigen (PSA) progression-free survival (PFS) failure rates during long-term treatment with 3-monthly subcutaneous (s.c.) injections of degarelix or goserelin in prostate cancer patients (PSA PFS failure is defined as…
Primary: To determine the effect of withdrawing to placebo versus continuing treatment with levoketoconazole on the cortisol therapeutic response previously established during open-label levoketoconazole therapy.Secondary:1. To compare the effects…
Primary: 1/ To evaluate the safety and tolerability of ribociclib with letrozole in men and postmenopausal women with HR+, HER2- aBC who received no prior hormonal therapy for advanced disease.Secondary: To assess the clinical efficacy of ribociclib…
to assess the efficacy of a 16-week treatment period of low dose amitriptyline (10-20 mg nightly) or mirtazapine (7.5 - 15 mg nightly) on subjective sleep quality compared to placebo added to usual care in patients with insomnia disorder with sleep…
The objective of this study is to assess long-term safety and efficacy durability of levoketoconazole as chronic treatment for endogenous Cushing*s Syndrome (CS).
The primary objective is to determine in which percentage of patients with prostate cancer with an indication for ADT, it is safe to extend the dosing interval of goserelin 10,8 mg by four weeks, before the 4th injection, using a testosterone based…
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)
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 primary objective of this study is to determine whether SAR439859 in combination with palbociclib improves progression free survival (PFS) compared to letrozole in combination with palbociclib in patients with ER +, HER2-advanced breast cancer…