58 results
Phase IThe primary aim of the phase I part of this study is to establish the safety profile and to determine the maximum tolerated dose of Re-188-HEDP combined with Capecitabine.Phase IIThe primary aim of the phase II part of this study is to obtain…
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.
The primary aim of the phase I part of this study is to establish the safety profile and to determine the maximum tolerated dose of capecitabine combined with Re-188-HEDP.The primary aim of the phase II part of this study is to obtain insight in the…
The primary objective of this study is to determine the efficacy and feasibility of the combination of everolimus and capecitabine in a group of patients with metastatic or locally advanced pancreatic cancer.
The primary objective of this feasibility/pilot study is to find the correct scanning protocol to assess 5FU drug trapping in colorectal cancer liver metastases using 7T MRS (phase 1). Secondary objectives will be assessed during phase 2 of this…
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…
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 objective is to determine whether the rate of severe toxicity (CTC grade 3 to 5) associated with fluoropyrimidine treatment can be significantly diminished by individualized dosing of fluoropyrimidines based on upfront genotypic…
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 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+)…
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…
Part I of this study is designed to identify the recommended phase 2 dose of the combination regimen of galunisertib/capecitabine as second line treatment in patients with 5-FU or capecitabine resistant colorectal carcinoma. Part II is designed to…
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.…
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…
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: To explore the safety and feasibility of neoadjuvant capecitabine, oxaliplatin, docetaxel, and atezolizumab in GE-junction and gastric adenocarcinoma Secondary objectives: • To assess pathological tumor regression and rates of…
This study investigates whether chemoradiotherapy (45 Gy in 5 weeks with daily cisplatin and capecitabine) after preoperative chemotherapy (3x ECC (epirubicin, cisplatin, capecitabine)) and adequate (D1+) surgery leads to improved survival in…
Primary Objectives:- To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in all randomized patients based on PFS (per RECIST 1.1 as assessed by BICR)- To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in…