20 results
Primary:Dual-agent dose escalation part (Part 1):• To determine the maximum tolerated dose of oral, daily (qd) BEZ235 in combination with paclitaxel, qw in patients with advanced solid tumors(MTD1, Arm 1).• To determine the maximum tolerated dose of…
The purpose of this phase I/II is to characterize the safety, tolerability, preliminary activity, pharmacokinetic (PK) and pharmacodynamics (PD) profile of TKI258 administered orally on a 5 days on/2 days off dosing schedule in adult patients with…
Primary: Part 1: Safety and tolerability. Determine the MTD and/or RP2D of MAK683.Part 2: Anti-tumor activity of MAK683.Secondary: Part 1: Anti-tumor activity. Pharmacodynamics (PD). Pharmacokinetics (PK).Part 2: Safety and tolerability. PK, PD.
This trial aims to investigate if peroperative administration of TA can reduce the peroperative and postoperative hemorrhage rates in laparoscopic sleeve gastrectomy.
Primary:To demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks compared to remaining on ABC/DTG/3TC (or DTG and an approved dual-NRTI scheme) over 48 weeks.Secondary:To…
Primary- To demonstrate non-inferior antiviral activity of DTG + 3TC versus DTG + TDF/FTC at 48 weeks in HIV-1-infected, ART-naïve subjectsSecondary- To demonstrate the antiviral activity of DTG + 3TC versus DTG + TDF/FTC at 24, 96 and 144 weeks- To…
Primary objective: To estimate the MTD/RDE of LOP628 in solid tumors and AML, respectively.Secondary objectivesL:- To characterize the safety and tolerability of LOP628- To characterize the pharmacokinetic profile of LOP628- To assess emergence of…
Primary: To determine the maximum tolerated dose (MTD) and thus the recommended phase IIdose and schedule of single agent oral BGJ398 in patients with advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation.Secundary objectives* to…
Primary: To demonstrate the non-inferior antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) over 48 weeks in HIV-1 infected antiretroviral therapy (ART) experienced subjects.…
Primary: Phase 1: To estimate the RP2D and/or the MTD for PDR001.Phase II: To estimate the anti-tumor activity of PDR001.Secondary: Both phases: Safety and tolerability, PK profile, emergence of anti-PDR001 antibodies, other parameters for…
Primary: Phase Ib: To estimate the MTD(s) and/or RP2D(s) of the triple combination of WNT974, LGX818 andcetuximab in patients with BRAFV600-mutant CRC harboring Wnt pathway mutations.Phase II: To estimate the preliminary anti-tumor activity of the…
Primary: To estimate the MTD and/or RDE for each of the following three treatment arms in patients with myelofibrosis.* PIM447 plus ruxolitinib (doublet)* Ribociclib (LEE011) plus ruxolitinib (doublet)* PIM447 plus ruxolitinib and Ribociclib (LEE011…
Primary objective:To assess the pharmacokinetics of the alternative maintenance QD regimen combining atazanavir, dolutegravir and lamivudine in HIV infected patients. Secondary objectives:To asses short term efficacy of the combination of atazanavir…
OT population excludes patients lost to follow-up, or that discontinued DTG for reasons of intolerance or toxicity. ITT = all patients that took at least 1 DTG tabletPrimary objective:* To evaluate the efficacy of DTG monotherapy in maintaining…
Primary objectives:- To assess the relative bioavailability of TAF and TFV after a single-dose FTC/TAF 3x60/7.5 mg DT (reference TAF) compared to TAF and TFV after a single-dose FTC/TAF 3x 60/7.5mg DT in combination with a single dose of DTG 30mg as…
Primary: Phase I: - To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. To further investigate the safety and tolerability of different doses of…
Secondary objectiveTo assess the safety and tolerability of the investigational treatments in patients with moderate to severe hidradenitis suppurativa (HS) by:• Number and severity of AEs • Physical examination, vital signs, safety laboratory…
Primary: To characterize the safety and tolerability of PDR001 and/or MBG453 in combination with decitabine or azacitidine in relapsed/refractory AML patients, de novo AML patients not candidates for standard induction therapy, or high risk or…
Primary: • Part 1:To evaluate the efficacy of NIR178 and PDR001 combination in patients with selected advanced solid tumors and diffuse large B cell lymphoma (DLBCL). • Part 2: To assess the efficacy of several intermittent dosing schedules of…
This trial aims to investigate whether peroperative administration of TXA reduces haemorrhage rates in patients who undergo metabolic surgery.