13 results
Primary objectives:1) Describe the PD effects on plasma ACTH and serum cortisol upon 100 µg hCRH injection with or without a preceding injection of 10 µg dDAVP 2 hours earlier and study the PK-PD relationship (*Block B*). In particular, the outcome…
PrimaryTo assess the extended overall response rates of orally administered TKI258, at 500 mg/day, on a five days on and two days off dosing schedule, in groups of patients with relapsed or refractory multiple myeloma who are* with t(4;14)…
Uspio enhanced MRI (MRL) potentially has the ability to show all lymph nodes and hence provide information on metastasis in all nodes, this is in contrast with SLNB which only provides information on 1 (or a few) lymph node(s). With MRL metastases…
Primary objectives* To determine the Overall Response Rate (ORR) in patients with (FGFR3MUT) advanced urothelial carcinoma treated with TKI258* To determine the Overall Response Rate (ORR) in patients with (FGFR3WT) advanced urothelial carcinoma…
To validate nano-MRI on 7 Tesla with pathological findings.
Primary Objectives1. To confirm superiority of Ferrotran®-enhanced MRI over unenhanced MRI in sensitivity to detect metastases in normal size pelvic lymph nodes in using histopathology after lymph node dissection as established reference method (…
Primary: treatment effect of TKI258 in combination with fulvestrant vs. fulvestrant plus placebo on Progression-Free Survival (voor for each of the 2 groups, namely FGF pathway amplified and regardless of FGF pathway amplification status).Secondary…
Primary objectivesTo evaluate the effect of the CYP1A2 inhibitor, fluvoxamine, on steady state pharmacokinetics of TKI258 in patients with advanced solid tumors, excluding breast cancerSecondary objectives• To characterize the safety and…
To collect long term data on safety and tolerability of dovitinib monotherapy.
To evaluate the effects of mild, moderate or severe hepatic impairment versus normal hepatic function on the pharmacokinetics of TKI258 in patients with advanced solid tumor
1. To compare the following imaging technologies to the current practice of histology of pelvic lymph node dissection: a. PSMAGa68 PET b. Nano MR Lymphography and an enhanced arterial map (Nano MRL / EAM) to locate the position of the lymph nodes2.…
To validate the use of 3 and 7 Tesla nano-MRI in restaging locally advanced rectal cancer by node-to-node matching of the results of nano-MRI with pathology as the gold standard.
The first objective is to improve preoperative staging with 3T NANO-MRI regarding the detection of lymph node metastases in patients with a pancreatic or periampullary carcinoma when compared to a conventional contrast-enhanced CT or MRI. Other…