27 results
Primary: The co-primary objectives of this study are* to compare independently adjudicated progression-free survival (PFS) following treatment with neratinib pluscapecitabine versus lapatinib plus capecitabine in patients with HER2-positive (HER2+)…
Primary objectives:Part A: To determine the recommended phase 2 dose and schedule (RP2D) of the selumetinib/afatinib combination in patients with KRASm and PIK3CAwt NSCLC and CRCPart B: To determine the progression free survival (PFS) of the…
Primary Objective: disease related treatment failure.Secondary Objectives: Overall survival, CRM negative (margin > 1 mm) rate, Pathological complete response (pCR) rate, Short and long-term toxicity, Surgical complications, Quality of life.…
Primary objective is to evaluate the area under the plasma concentration-time curve (AUC) of capecitabine alone, compared to capecitabine used with esomeprazole and compared to capacitabine used with esomeprazole and the acid beverage Coca-Cola in…
The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, Pembrolizumab (MK-3475) compared to other chemotherapy drugs of physician*s choice (which includes Capecitabine, Eribulin, Gemcitabine…
Primary objective is to determine the plasma pharmacokinetics of ModraCape001 and compare these to the pharmacokinetic profile of Xeloda®.Secondary objectives are:• To determine the AUC in blood plasma of capecitabine and its metabolites 5-dFCR, 5-…
Pertuzumab is the investigational agent being studied for the treatment of HER2-positive gastric cancer. This study is to compare the overall survival (OS) in patients treated with pertuzumab in addition to trastuzumab (Herceptin®) plus cisplatin…
To investigate wether neo-adjuvant chemotherapy followed by cytoreductive syurgery and hyperthermic chemotherapy is feasible and reduces the number of irresectable patients with acceptable morbidity and mortality rates.
Primary objective: To compare progression-free survival (PFS) as assessed by blinded, central review between patients randomized to niraparib versus physician*s choice. Key secondary objective: To compare overall survival between patients randomized…
Primary:The primary objective of this study is to demonstrate that the overall progression-free survival (PFS) of 8 cycles of intermittent (2 times 4 cycles) chemotherapy (paclitaxel) is not inferior in efficacy, compared to 8 continuous cycles of…
The primary study objective is to compare the efficacy, as assessed by overall survival, of surgery and neo-adjuvant chemotherapy to surgery alone in patients with resectable liver metastases of colorectal cancer and a high clinical risk score.…
To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).
Primary Objective: To establish a prediction model for the probability of vaginal delivery and successful vacuum extraction at the second stage of labor, using the angle of progression by transperineal ultrasound. Secondary Objective(s): To evaluate…
This study will evaluate 2 different treatment strategies : a combination of S 95005 and bevacizumab (experimental combination) and a combination of capecitabine and bevacizumab (control arm) as first-line treatment for metastatic colorectal cancer…
The primary objective is to determine the incidence of HFS in first line treatment with S-1 compared to capecitabine in patients with metastatic colorectal cancer. Secondary objectives include a comparison of efficacy.
Primary Objectives:- To evaluate and compare the overall survival (OS) of subjects with advanced or metastatic adenocarcinoma of the pancreas when treated with JAK 1/2 Inhibitor in combination with capecitabine versus capecitabine alone.Secondary…
The primary objective of this study is to evaluate the effect of dalcetrapib on HDL-C levels after 4 weeks of treatment whentreatment is initiated within 1 week after an ACS. The secondary objectives of this study are:- To compare the effect of…
Primary:- to characterize the metabolic profile of dalcetrapib and identify circulating and excreted metabolitesSecundary:- to explore the influence of drug metabolizing enzyme and drug transporter genotype on the metabolic profile of dalcetrapib.-…
Primary:• Arm 1: To determine the maximum-tolerated dose (MTD) and doselimitingtoxicity (DLT) of single agent LBY135 and LBY135 when administered in combinationwith capecitabine to adult patients with advanced solid tumorsSecondary:• To characterize…
The primary objective is to gain experience with primary radiochemotherapy and to determine the locoregional response rate at 12 weeks after radiochemotherapy and after groin dissection for cN1,2 patients.