18 results
Primary objective: Safety.Secondary objective: Efficacy.
Therefore, we aim to investigate in a pilot trial the effect of SOM230 on predefined endpoints in patients with moderate to severe GO whom have contraindications for prednisolone therapy or decline from prednisolone therapy for other reasons.
PrimaryAssess the safety profile of pasireotide s.c. during the first 8 weeks of treatment with pasireotide s.c.SecondaryAssess the safety profile of pasireotide s.c.at study completionAssess tumor response as measured by disease control rate (DCR)…
Primary To evaluate the treatment effect of pasireotide s.c. on plasma glucose levels during GTT at the end of s.c. dose escalation phase.Secondary: Pulse rate, hematocrit, insulin, glucagon, GLP-1 and GIP secretion during GTT at the end of s.c.…
To compare the long term efficacy of pasireotide LAR vs. octreotide LAR at month 6 in controlling diarrhea and/or flushing in patients with metastatic carcinoid tumors whose disease-related symptoms are inadequately controlled by the maximum…
The objective of the study is to improve medical treatment of Cushing's disease by combining partially independent medical therapies which act through differential mechanisms. Given the high affinity of SOM230 to sst5 and considering the facts…
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…
The purpose of this study, is to evaluate the efficacy and safety of pasireotide alone or in combination with cabergoline in patients with Cushing*s disease as measured by the proportion of patients achieving normal UFC at the end of the study…
To investigate disease control after nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer.
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…
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…
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…
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…
This study aims to investigate the retina, macula and optic nerve head with Optical Coherence Tomography (OCT) in a cohort of AD patients in order to identify a neurodegenerative signature of AD consisting of neuroretinal degeneration, vascular…
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…
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 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…
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.