60 results
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…
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-…
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…
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 Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
Main objective: The main objective of this open-label, single arm study is to further characterize the safety, tolerability and effectiveness profile of olesoxime in SMAThe primary safety objective for this study is as follows:To evaluate the safety…
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…
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…
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 hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…
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…
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…
The primary objective is to quantify the LIN AUC0-12h increase after addition of 250 mg, or 500 mg CLA compared to baseline (0 mg CLA). The secondary objectives are to describe the LIN and CLA pharmacokinetic parameters and to assess short-term…
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.
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…