60 results
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…
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: 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…
To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).
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.
To determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs) and recommended dose (RD) of continuous and intermittent chronomodulated capecitabine.Secondary study objectives are:To determine plasma pharmacokinetics of capecitabine…
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…
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…
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-…
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: Progression free survival.Secondary: Toxicity, overall survival, response rate, duration of response, translational research.
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…
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: 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 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 the study is to prospectively determine whether fluoropyrimidine-induced toxicity is preventable by dose adjustment prior to start of the first administration based on the polymorphic status of the DPYD*2A polymorphism in…
* The primary objective of this study is:- the study of the response rate and the macroscopic and microscopic response charactheristics of neo-adjuvant chemotherapy of patients with peritoneal carcinomatosis (PC) of colorectal origin. * Secundary…
To establish the MaximumTolerated Dose, Dose Limiting Toxicities, and the safety profile of BMS-833923 administered in combination with cisplatin and capecitabine as first-line therapy. To describe preliminary evidence of tumor response as measured…