59 results
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 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…
PrimairTo determine the MTD and/or RP2D of oral twice daily (BID) BEZ235 in combination with trastuzumab in patients with HER2-positive breast cancerSecondairTo assess the preliminary activity of the combinationTo assess the safety and tolerability…
* 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…
The primary objective of the study is assessment of the dose limiting toxicity (DLT) and maximal tolerated dose (MTD) of docetaxel, oxaliplatin and capecitabine given in combination in patients with advanced cancer of the stomach or the gastro-…
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…
MK-1439 is a promising NNRTI to be used in combination with other antiretrovirals (ARTs) for the treatment of HIV infection. It is a potent inhibitor of HIV-1 replication in vitro and is active against both wild type virus and most common NNRTI…
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 compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).
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 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…
The purpose of the study is to delineate the upstaging percentage of pN0 patients by detection of micrometastases (pN0micro+) and evaluate the benefits from adjuvant chemotherapy on disease recurrence in pN0micro+ CC patients.
Primary: To assess the effect of multiple oral doses of 600 mg efavirenz once daily on the PK of BMS-790052 at steady state in healthy subjects.Secondary: To assess the safety of multiple oral doses of BMS-790052 given alone and together with…
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…
To determine the efficacy of the combination of everolimus and capecitabine in a group of patients with metastatic or locally advanced HCC with Child-Pugh class B liver cirrhosis. In addition, to investigate biomarkers of HCC before and during the…
This trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. It is anticipated that the time on study (which is the time…
This study investigates the feasibility role of neoadjuvant chemotherapy, consisting of docetaxel (Taxotere), cisplatin and capecitabine (Xeloda) (TCX), and protocolized surgery in localized and/or locally advanced resectable gastric cancer (D1extra…
The primary objective of the trial is to demonstrate non-inferiority of treatment with TMC278 when administered as 75 mg q.d. compared to the control group (EFV) in regard to the proportion of virologic responders (plasma viral load < 50 HIV-…