28 results
A better understanding on the individual response to different albuminuria lowering drugs and a better understanding why these drugs, of which some are developed for another indication, may help to tailor optimal therapy. Therefore in this study…
Primary objective is: * To determine the overall survival (OS) benefit of PAG treatment, compared with AG treatment, in subjects with HA-high Stage IV previously untreated PDA.Secundary objectives are:* To determine the PFS benefit of PAG treatment…
Primary:The primary objective of this trial is to evaluate whether empagliflozin 10mg/day will relieve dyspnea, improves diuretic response, decreases length of initial hospital stay and NT-proBNP compared to placebo during hospital admission for…
To evaluate the radiologic progression-free survival (PFS) of subjects treated with the combination of gemcitabine/docetaxel (G/D) plus MORAb-004 versus G/D plus placebo in subjects with metastatic soft tissue sarcoma (mSTS)Secondary Objectives:* To…
The primary objective of this study is to estimate the best objective response rates (ORR; complete response [CR] + partial response [PR]) associated with gemcitabine-cisplatin plus necitumumab in chemotherapy-naïve patients with Stage IV squamous…
Phase A:Primary objective: Determining the feasibility of gemcitabine as a radiosensitizer in DIPG Secondary objective: Evaluation of efficacy in terms of clinical and radiological response rate and progression free survivalTertiary objectives:…
Phase ITo determine the toxicity and optimal dose of LDE225 when co-administered with fixed doses of gemcitabine and nab-paclitaxel in patients with advanced and metastasized pancreatic cancer.Phase IITo determine the anti-tumor activity of LDE225…
The objective of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of once daily oral doses of empagliflozin 10 in patients with Type 1 diabetes mellitus (T1DM) as adjunctive to insulin therapy. Empagliflozin is…
The study will look at patients with advanced Non-Small Cell Lung Cancer (NSCLC) whose tumours express a certain type of protein called PD-L1. The research aims to compare a new drug called nivolumab against Investigator's choice of…
Main study objective is to find out which dose among three different doses of LIK066 is the most efficacious, safe and well tolerated in type 2 diabetes patients with heart failure. We will also learn which medication is better at managing patients…
To ascertain whether the pharmacokinetics of gemcitabine in a therapeutic dose can be predicted from the pharmacokinetics of a microdose.
The objective of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of once daily oral doses of empagliflozin 2,5mg, 10mg and 25mg in patients with Type 1 diabetes mellitus (T1DM) as adjunctive to insulin therapy.…
The primary objective of this study is to assess the objective response rate (ORR, the percentage of treated patients in whom the tumor significantly reduces in size or becomes non-detectable) of SAR240550 administered as a 60min intravenous…
A better understanding on the individual response to different albuminuria lowering drugs and a better understanding why these drugs, of which some are developed for another indication, may help to tailor optimal therapy. Therefore in this study…
Primary objective:To determine the safety and tolerability of multiple, once-daily oral doses of CNP520 over 13 weeks in healthy elderly subjectsSafety: ECG, vital signs and laboratory data; assessment of cognitive function; dermatological…
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…
Phase I part To determine the recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer.Phase II part 1) To investigate the proportion of patients…
The primary objective of the Phase 2 part of the study is to determine if overall survival(OS) in patients with Stage II-IV unresectable pancreatic cancer administered LY2603618 and gemcitabine combination therapy exceeds gemcitabine monotherapy OS.…
To determine the MTD toxicity of standard dose cetuximab together with concurrent individualized, isotoxic accelerated radiotherapy and cisplatin-vinorelbine.
Objectives:Primary Objective:* To compare the overall survival (OS) distributions of RP101 and gemcitabine to placebo and gemcitabine in subjects with unresectable, locally advanced or metastatic pancreatic adenocarcinomaSecondary Objectives:* To…