13 results
The objective of the current study is to investigate the efficacy, safety and tolerability of BI10773 (25mg once daily) compared to glimepriride (1-4mg daily) given for 104 weeks with a 104-week extention period in patients with type 2 diabetes…
For Part A: the purpose of this part is to investigate the effect of multiple oral doses of the new study drug on how quickly and to what extent glimepiride is absorbed and eliminated from the body (this is called pharmacokinetics), if glimepiride…
Primary:* To compare overall survival (OS) in subjects with advanced soft tissue sarcoma ([STS], one of two subtypes: adipocytic [ADI] or leiomyosarcoma [LMS]) when treated with eribulin (Arm A) or dacarbazine (Arm B).Secondary:* To compare…
Primary Objective* To compare the objective response rate and overall survival of BMS-936558 to investigator*s choice in subjects with advanced melanoma.Secondary Objectives* To compare the progression-free survival (PFS) of BMS-936558 to…
The main objective of the trial is to show that ABVD-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification (BEACOPP) in case of a positive FDG-PET after one cycle of ABVD, has non-inferior efficacy…
A pilot feasibility study (n=5) will be performed to evaluate the feasibility (logistics, timing) and safety of administering autologous tumor infiltrating lymphocytes (TIL) generated at the NKI-AVL infused in conjunction with systemic high-dose…
To compare OS in patients with previously untreated Stage IIIc, N3 (unresectable) or Stage IV melanoma receiving dacarbazine plus 10mg/kg ipilimumab (MDX-010) vs. dacarbazine with placebo.
Primary objective:* To compare the clinical efficacy of nilotinib to DTIC, based on progression free survival (PFS), in the treatment of c-Kit mutated melanoma in patients who have not received prior therapy with TKIs.Key secondary objectives:* To…
Primary objective: What are the long-term effects (i.e. after 8-week drug exposure) of the DPP-4i linagliptin versus the SU derivative glimepiride on fasting and postprandial renal hemodynamics (glomerular filtration rate (GFR)/ effective renal…
Primary objectiveTo compare the progression-free survival (PFS) of subjects treated with either pimasertib or dacarbazine.Secondary objectivesEfficacy- To compare the objective response of subjects treated with either pimasertib or dacarbazine.- To…
The objective of the study is to diminish the amount of chemotherapy and/ or radiotherapy for children with Hodgkin lymphoma who are likely to receive too much treatment with current treatment protocols.
CAROLINA studyThe aim of the present study is to investigate the long*term impact on CV morbidity and mortality and relevant efficacy parameters (HbA1c, fasting plasma glucose, treatment sustainability) of treatment with linagliptin in a relevant…
The aim of the trial is to individualize treatment for each patient by adapting it to early response and to treat only those patients with addiotional radiotherapy who show an inadequate treatment response. The degree of treatment response is…