27 results
Primary Objective• For Arms A, B, and C: Determine the overall response rate (RR) of EZN-2208 for two distinct cohorts of patients with mCRC- Patients with mutated K-RAS tumors (Arm A)- Patients with wild-type K-RAS tumors (Arms B and C)• For Arms B…
To study the role of central insulin on glucose metabolism.
Primary:1) To compare OS in subjects with squamous cell carcinoma of the Esophagus.2) To compare OS in subjects with PD-L1 Combined Positive Score (CPS)*10%3) To compare OS in all subjectsSecondary:1) To evaluate the progression free survival (PFS)…
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:…
To evaluate the inter- and intra-subject variability in pharmacokinetics (PK) and pharmacodynamics (PD) of study drug following a two-period repeated single dose of 2 mg delivered by subcutaneous (SC) injection in healthy volunteers.
Primary: To provide metastatic colorectal cancer patients with access to aflibercept and todocument the overall safety in these patientsSecondary: To document the Health-Related Quality of Life of aflibercept in this patientpopulation
Evaluate the outcomes of a relatively brief but intensive IV insulin therapy compared to conventional therapy in patients admitted for ACS and observe different biomarker washout patterns these treatment groups.Furthermore we wish to determine…
To determine whether glucose, lipid and protein metabolism can be accurately measured using stable isotopes in the same patient on two occasions in a 48 hour interval.
1) To assess insulin sensitivity and response in critically ill septic neonates and children. 2) To determine protein balance in septic, critically ill children at baseline and during a Hyperinsulinemic Euglycemic Clamp, while receiving standard or…
To study the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively on the occurrence of cardiovascular complications and death from all causes at 30 days and at 1 year after non-cardiac surgery in diabetics.
This protocol is designed to determine the safety, tolerability, and efficacy of SGI-110 in combination with irinotecan in previously treated patients with metastatic colorectal cancer who progressed on irinotecan.
Primary objective: To evaluate the effect of treatment with oral hypoglycemic agents (OHA) on the incidence of large-for-gestational-age (LGA) infants in women with GDM requiring medication, compared to insulin (INS) treatment.Secondary objectives:…
PRIMARY OBJECTIVES*Phase 1 Dose Finding Studies:-To determine the recommended phase II dose (RP2D) of new systemic therapy regimens. *Frontline chemotherapy questions:-To compare systemic therapy regimens for patients with VHR disease at diagnosis (…
The aim of this study is to assess the effectiveness of the addition of neoadjuvant induction FOLFOXIRI systemic therapy to chemoradiotherapy in patients with high-risk locally advanced rectal cancer on short- and long-term outcome. The objective is…
Main objective of this project is to establish the maximum tolerable dose (MTD) and recommended phase II dose of intraperitoneal irinotecan in patients with PC of colorectal origin, added to standard of care systemic chemotherapy. Other endpoints…
The primary goal of the study is to establish the maximum tolerated dose (MTD) of intraperitoneal administration of irinotecan, added to systemic capecitabine/oxaliplatin (CAPOX) in patients with peritoneal carcinomatosis of gastric origin.…
To find the maximum tolerated dose of glass yttrium-90 (90Y) microspheres (TheraSphere®), when combined with DEBIRI in patients with liver-dominant colorectal liver metastases (CRLM).
Main objective:The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. Thisevaluation will follow a…
The primary objective of this study is to determine whether the addition of induction chemotherapy to the neoadjuvant treatment of patients with locally recurrent rectal cancer results in more R0 resections compared to treatment with neoadjuvant…
To determine the median progression-free survival (PFS) and R0/1 secondary resection rate upon induction systemic treatment in colorectal cancer patients with initially unresectable liver-only metastases, stratified by RAS and BRAF tumor mutation…