42 results
To determine the effect of Pre-OP, in addition to perioperative intravenous antimicrobial prophylaxis on the cumulative incidence of deep surgical site infections (SSI) and/or mortality within 30 days after surgery in patients undergoing elective…
Primary objectives Phase I: To determine the recommended phase 2 dose (RP2D) of the lapatinib-trametinib combination in patients with KRASm NSCLC Phase II: To determine the progression free survival of the lapatinib-trametinib combination compared…
Primary objectivesPhase I:To determine the recommended phase 2 dose (RP2D) of the dacomitinib-PD-0325901 combination in patients with KRASm NSCLC Phase II:To determine the progression free survival of the dacomitinib/PD-0325901 combination compared…
Primary objectives Phase Ib: To estimate the MTD and/or RP2D of LGX818 in combination with cetuximab ± BYL719. Incidence of dose-limiting toxicities (DLTs). Phase II: To compare the efficacy of the dual (LGX818, cetuximab) and triple (LGX818, BYL719…
The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…
Primary To determine the maximum tolerated dose (MTD) and characterize the dose-limiting toxicities (DLT) of LEE011 when administered orally once daily for 21 consecutive days followed by a 7 day break.Secondary *Safety and tolerability of LEE011.*…
To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm.
The purpose of the multicenter, randomized, open-label, parallel-group study EFC11628 is to compare the efficacy and safety of HOE901-U300 with that of Lantus®, both given once-daily s.c. as part of a basal-bolus insulin regimen in patients with…
The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…
Primary objective(s)• To evaluate the efficacy of blinatumomab to induce complete MRD responseKey secondary objective for patients with Ph-negative ALL • To evaluate the effect of blinatumomab on hematological relapseOther Secondary objectives• To…
Primary objective: To determine the MTD/highest studied dose determined to be safe, the safety and tolerability of INC280 as a single agent when administered orally to adult patients with c-MET dependent advanced solid malignancies.Secondary…
The primary objective of this study is to assess the safety, tolerability, and pharmacokinetics of ABT-767 and the effect of food on ABT-767 bioavailability in subjects with BRCA1 or BRCA2 germ line mutation and associated solid tumors (e.g. breast…
Primary objective:To evaluate the effect of each of 2 doses of AK001 separately in combination with an INS versus the INS alone on the reduction in size of nasal polyps as evaluated by the change from Baseline to Week 12 after the start of treatment…
Objective(s): Part 1: To determine the safety, tolerability, pharmacokinetics (PK), and efficacy of single ascending doses of OPC-108459 following one 10-minute constant rate infusion in adultsubjects diagnosed with paroxysmal or persistent AF. Part…
The primary objective of the study is to determine the MTD (maximum tolerated dose) and/or RDE (recommended dose for expansion) of BGJ398 in combination with BYL719.The secondary objectives are to characterize the safety and tolerability of BGJ398…
Primary objective:The primary objective of the trial is to evaluate efficacy, as measured by overall survival (OS), of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with previously untreated…
The objective of this study is to explore the efficacy and safety of gevokizumab in patients with Schnitzler syndrome.
Primary Objective:To compare the efficacy of pacritinib with that of Best Available Therapy (BAT) in patients with PMF, PPV-MF, or PET-MF; the efficacy measure for this analysis is the proportion of patients achieving a * 35% reduction in spleen…
The objective of this study is to establish the optimal intranasal cobalamin dosing regimen in elderly.
To evaluate the efficacy (superiority) and safety of BAY 41-6551 as measured by the comparison of the clinical cure rate of aerosolized BAY 41-6551, administered via the PDDS Clinical, versus placebo (normal saline) at the Test-of-Cure (TOC0 visit…