22 results
Objective is to show equivalence with respect to the efficacy of sugammadex in subjects with normal or severely impaired renal function, to evaluate the safety of sugammadex in these subject groups and to compare the pharmacokinetic profiles.
The main goal of neoadjuvant therapy should be a pathological complete response (pCR), because pCR more accurately predicts improved patient outcome and prolonged survival. In the present study, pathological response will be evaluated by The Miller…
To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine iv chemotherapy as treatment in patients with HER2-overexpressing, metastatic breastcancer, who failed one prior trastuzumab treatment.
Primary:Dual-agent dose escalation part (Part 1):• To determine the maximum tolerated dose of oral, daily (qd) BEZ235 in combination with paclitaxel, qw in patients with advanced solid tumors(MTD1, Arm 1).• To determine the maximum tolerated dose of…
MAIN OBJECTIVESDose escalation study:To establish the safe use of trastuzumab (Synthon BV, the Netherlands) in healthy volunteers at different dose levels up to 6 mg/kg.Bioequivalence study:Demonstrate bioequivalence between trastuzumab (Synthon BV…
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…
Primary Trial Objective:To assess the effect of reversal of neuromuscular blockade with sugammadex 4 mg.kg-1 compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of adjudicated postsurgical events of…
Pertuzumab is an investigational agent being studied for the treatment of HER2-positive gastric cancer. This study intends to provide a dose of pertuzumab to find an acceptable minimum pertuzumabconcentratie pertuzumab effective when administered in…
Primary objective: To establish whether concomitant therapy of trastuzumab, bevacizumab with paclitaxel (regimen A) and/or trastuzumab and bevacizumab followed by the combination of trastuzumab, bevacizumab, and paclitaxel at progression (regimen B…
Primary objective(s)Phase Ib:-Define the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD) of AUY922 in combination with Trastuzumab in patients with advanced or metastatic HER2-positive breast cancers.Phase II:-Evaluate…
The main aim of the present study is i)To assess whether sugammadex has a positive effect on the post-operative alertness of the patients, and ii) to assess the nature, magnitude and the time of onset of this effect (if any).
Primary: To estimate the MTD or RDE and preferred dosing schedule of LJM716 when administered in combination with trastuzumab in patients with HER2 overexpressing metastatic breast cancer or gastric cancer.Secondary: Safety and tolerability, PK, PD…
To investigate the potential of an interaction between 4 mg/kg and 16 mg/kg sugammadex and enoxaparin or UFH on anticoagulant activity in young healthy male volunteers.
Primary: To determine the response of 2B3-101 treatment as single agent or in combination with trastuzumab in patients with LM from breast cancer using the LM response scoreSecundary: - To determine the safety profile in patients with LM treated…
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: Progression free survival.Secondary: Toxicity, overall survival, response rate, duration of response, translational research.
Primary Objective:• To assess the safety and tolerability of 2B3-101 when administered intravenously (IV) as single agent in patients with solid tumors and brain metastases or recurrent malignant glioma in order to determine the Maximum Tolerated…
Primary objective is to evaluate the use of deep muscle relaxation versus on indication only on surgical and anesthesia conditions in patients for endoscopic esophageal resection.Secondary objective is to evaluate the (hypothetical) dose of…
To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).
The main objectives are to evaluate the efficacy (as measured byprogression free survival at 6 months) of pertuzumab combined withtrastuzumab (PH) or PH plus metronomic chemotherapy (PHM) in anelderly metastatic breast cancer population, and to…