14 results
The main objective is to assess the efficacy of the closed loop system at the home of the patient. Secondary objectives are to assess the safety of the new prototype while the telemonitoring intensity is being reduced during the trial; to…
The purpose of the study is to investigate how quickly and to what extent radiprodil is absorbed and eliminated from the body (this is called pharmacokinetics). It will also be investigated to what extent radiprodil is tolerated. In addition, 2 new…
Primary:In 1L subjects with metastatic squamous non-small cell lung cancer (NSCLC) receiving investigator*s choice of standard of care chemotherapy (i.e. carboplatin and a taxane):1. Evaluate progression free survival (PFS) per RECIST 1.1 as…
To investigate disease control after nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer.
Unless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + nab-paclitaxel (Arm B) versus carboplatin + nab- paclitaxel (Arm C)• Atezolizumab + carboplatin + paclitaxel…
The main objective of this study is to assess efficacy of the closed loop system in patients after total pancreatectomy. Secondary objectives are to assess the safety of the closed loop system; to determine the time that the control algorithm is…
The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, Pembrolizumab (MK-3475) in combination with chemotherapy drugs of physician's choice (which includes Nab-paclitaxel, Paclitaxel or…
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…
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…
To compare overall survival (OS) of patients with metastatic (Stage IV) PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine.
Primary Objective:- To compare progression-free survival (PFS) as assessed by blinded independent central review (BICR) between sacituzumab govitecan (SG) and pembrolizumab versus treatment of physician*s choice (TPC) and pembrolizumab. Secondary…
The primary objectives are to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D) of ABBV-621 and to evaluate pharmacokinetics (PK) of (A) single agent ABBV-621; and (B) the combination of ABBV-621 and venetoclax in…
The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line mPDAC.This study aims to explore whether blockade of Transforming…
Primary Objective:-To determine the long-term safety and tolerability of multiple individually titrated doses of radiprodil as an addon therapy to standard of care (SOC)in pediatric participants-To establish a safe and well tolerated dose after 8…