52 results
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 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 determine the tacrolimus bioavailability after tacrolimus administration via a rectiole.
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 compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).
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-…
Primary Efficacy Objective* The primary objective of this study is to evaluate the efficacy of two dose levels of pregabalin compared to placebo as an adjunctive treatment in reducing the frequency of partial onset seizures in pediatric subjects 1…
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…
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…
The effect of pregabalin treatment on patients with chronic pancreatitis
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…
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…
Aim of the study is to evaluate RPL554*s safety in healthy, non-asthmatic subjects and consequently to assess RPL 554 safety and efficacy in allergic asthmatics and in allergic rhinitics.
In this study we want to determine the activity and safety of concurrent interruption of the MAPK and PI3K pathways by EGFR and mTOR inhibition in patients with metatastatic pancreatic cancer
Primary objective of the study is the assessment of the dose limiting toxicity (DLT) and the maximal tolerated dose (MTD) of capecitabine and mitomycin-C with concomitant SIBRT in patients with locally advanced anal carcinoma.Secondary objectives…
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 objective:To assess the safety of nebulised RPL554 at 2 single, ascending, inhaled doses of 0.036 mg/kg (12X) and 0.072 mg/kg (24X) in allergic asthmatics using standard safety measures with intensive monitoring of any potential…