45 results
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.…
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 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: Progression free survival.Secondary: Toxicity, overall survival, response rate, duration of response, translational research.
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.…
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 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 compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).
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.
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.
To establish the drug drug interaction of paracetamol with propranolol and the effect of this interaction on the pharmacokinetic profile and metabolites of paracetamol.
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…
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…