phase i clinical trials with anticancer agents

... Immunohistochemical analysis of vitiligo Biopsy specimens of the area with vitiligo in P2 were stained with H&E to identify infiltrating cells This focus was a match for vitiligo To characterize ... specific lysis of inhibition by isotype control) - (% specific lysis of inhibition by MAb)]/(% specific lysis of inhibition by isotype control) × 100 All mAb was purchased from Dako Japan Inc Immuno-histochemical ... primary endpoint and clinical and immunological responses as secondary endpoints Six patients with stage IV melanoma were immunized with a vaccine consisting of the epitope peptide emulsified with...

Ngày tải lên: 18/06/2014, 16:20

... clinical efficacy Therefore, it will be desirable to examine the clinical efficacy of rh-HGF in additional clinical trials involving patients with less severe conditions Systemic administration ... Registration of Pharmaceuticals for Human Use (ICH)-Good Clinical Practice (GCP)-registered phase I/ II clinical trial of rh-HGF As this application is the first clinical trial to administer rh-HGF to humans, ... patients with less severe conditions, will be valuable in determining the clinical efficacy of rh-HGF Additional material Additional file 1: Clinical course of patient with FHSA, the first patient...

Ngày tải lên: 18/06/2014, 19:20

... dose in most phase I trials Finally, although evaluation of clinical efficacy is not the purpose of phase I trials, the clinical outcomes for patients enrolled in these trials is of major interest ... http://www.jhoonline.org/content/1/1/20 A phase II clinical trial using CT-322 alone or in combination with irinotecan has opened for patients with recurrent gliobastome multiforme; the dose used in this trial ... study drug, occurring within a specified time period after drug delivery, although variations of DLT definitions may exist based on anticipated toxicity from preclinical data Maximum tolerated dose...

Ngày tải lên: 10/08/2014, 22:20

... OprF-OprI vaccine can be effective in patients with CF and other conditions Recent data of a phase III clinical trial with CF patients evaluating a bivalent flagella vaccine of P aeruginosa suggest ... consistent with this dual origin of bronchial IgG antibodies IgA antibody levels in IS showed no correlation to systemic and BALF antibody levels of this isotype These findings are consistent with a ... composition of first BAL fractions Studies comparing cellular components obtained with BAL and IS support a differential origin of the samples with IS deriving from the central airways [14,20] This...

Ngày tải lên: 12/08/2014, 15:21

... http://www.translational-medicine.com/content/7/1/68 administration of equivalent mixtures of antibody and IL2 [6] EMD 273063 was tested in a phase I clinical trial aimed at evaluating its safety, toxicity and in vivo immunological ... increased with higher doses in the prior phase I/ II clinical trials, whereas there was evidence of reproducible immune activation at this dose level [7,8] Methods Study design and endpoints Study ... Treatment with this agent is associated with immunologic effects as reflected by an increase in immune-related cytokines in serum and intratumoral changes in some patients consistent with increased intratumoral...

Ngày tải lên: 18/06/2014, 15:20

... 2D-docking images of compound 6a, depicting its vicinity with DNA phobic interactions.42,43 This fact is well established by DNA titration experiments and docking studies and can be seen in Figure ... series) The critical evaluation and 3D visualization of compound 4a model (Figure 6a) indicated that 4-nitro-phenyl moiety is inside the minor groove while the remaining part is outside Nitro ... occasionally with some hyperchromicity Contrarily, outside binding with self-stacking shows quite similar characteristics as the intercalative binding mode but to a lesser extent.35–37 The absorption...

Ngày tải lên: 01/07/2014, 13:23

... 402 414 IR IR IR IR IR IR and ER ER ER IR IR IR IR IR IR IR IR ER ER IR ER ER ER Fixed Fixed Flexible Fixed ranges Flexible Flexible Flexible Flexible Flexible Flexible Flexible Flexible Fixed ranges ... serotonin reuptake inhibitors, and serotonin-norepinephrine reuptake inhibitors [5,6] The trials in this analysis all included patients with MDD However, the diagnostic criteria differed according ... Psychiatric Association; 1981 American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders (DSM-III-R) Washington, DC, USA: American Psychiatric Association; 1987 American...

Ngày tải lên: 08/08/2014, 23:21

... diluting 1:5 with 0.375 M perchloric acid to inactivate PEG-uricase Uric acid in the acidified plasma was quantified by HPLC as described above for the pUox assay To be consistent with clinical ... competition experiment shown in Figure 6a, preincubating antibody-positive day 14 plasma from subject 013 with up to 200 µg/ml unnmodified recombinant uricase did not inhibit the ELISA, indicating ... preliminary experiments, specific signals could be obtained with NPC-activated mPEG and mPEG-glycine, but not with mPEG itself Because mPEGs, when in solution, did inhibit in competition experiments...

Ngày tải lên: 09/08/2014, 07:20

... nelfinavir [24] or erlotinib, gefitinib and bevacizumab [25-27] with a CRT regimen, although further confirmation of initial positive results in phase I studies is warranted by randomised trials ... late toxicity As in our study, the acute toxicity consisted of dose-limiting GI toxicity Application of the linear quadratic model indicates that 42 Gy in 2.8 Gy-fractions is biologically equivalent ... indication of anti-tumour activity [13,15,16] In a phase I study by McGinn et al to find the MTD of gemcitabine in association with RT to 50.4 Gy in 1.8 Gy daily fractions in patients with locally...

Ngày tải lên: 09/08/2014, 09:22

... encouraging preliminary outcome results An additional phase I/ II trial concerning 27 patients with brain metastases treated with radiation and celecoxib [77] confirmed the feasibility and safety Govindan ... cancer is not increased Further phase II and III testing is required for efficacy testing IGF-R Insulin-like growth factor receptor mg Milligram MRI Magnetic resonance imaging Abbreviations AP ... phase I/ II trials combining celecoxib with either radiation or radiation plus chemotherapy have to be expected Although initially announced to be pain medications with an low and optimal toxicity...

Ngày tải lên: 09/08/2014, 10:20

... belimumab was biologically active in vivo and was safely administered to patients with SLE These findings supported the initiation of phase II studies investigating the safety and clinical activity ... or two doses of belimumab compared with placebo This is consistent with the ability of belimumab to inhibit BLyS biologic activity Significant reductions in anti-dsDNA antibody were observed ... urticaria with chest pain was reported in one patient with a prior history of drug-induced urticaria during the administration of a 20 mg/kg single dose The infusion was discontinued approximately...

Ngày tải lên: 09/08/2014, 13:21

... levels of illumination and/or fixed timing of behavior had significant circadian phase- shifting effects The large phase- shifts resulted in a significant increase in circadian malsynchronization, rather ... employed in the majority of clinical trials of bright light treatment [24], so an insufficient duration might explain the lack of significant effect An insufficient duration or intensity of light ... Social interaction may have significant independent zeitgeber effects, and can act synergistically with light exposure Clinically, it is relevant to examine light effects in the presence of social...

Ngày tải lên: 10/08/2014, 09:20

... 30:38-43 Neri M, Cerretani D, Fiaschi AI, Laghi PF, Lazzerini PE, Maffione AB, Micheli L, Bruni G, Nencini C, Giorgi G, D’Errico S, Fiore C, Pomara C, Riezzo I, Turillazzi E, Fineschi V: Correlation ... pharmacokinetic information was available With the second dose we wished to investigate the possible benefit of postoperative inhibition of fibrinolysis on IR The patients were randomly assigned, ... median and percentiles b Inter-atrial communication D-dimer [3,20,21] This amplified IR is especially relevant in CPB In a previous study, we observed significantly higher levels of IL-6 in patients...

Ngày tải lên: 10/08/2014, 09:22

... pancreatic) The combination may have clinical activity in patients with solid tumors in general and pancreatic cancer in particular Phase II at the dose of 90 mg of MGCD0103 is ongoing in patients with ... decitabine at a five day schedule in combination with HDAC inhibitors is ongoing [139,140] A phase II study of hydralazine and VPA in treating patients with advanced solid tumors revealed clinical ... Schmitt M, Lee JH, DeConti R, et al: Phase I trial of histone deacetylase inhibition by valproic acid followed by the topoisomerase II inhibitor epirubicin in advanced solid tumors: a clinical...

Ngày tải lên: 10/08/2014, 22:20

... from within the Eli Lilly and Company Clinical Trial Database, met inclusion criteria, including trial each comparing olanzapine to risperidone [13], quetiapine [14], and aripiprazole [15], and trials ... risperidone, quetiapine, or ziprasidone to prevent additional loss of response in patients who initially achieved response Poor adherence to antipsychotic therapy is a clinically significant issue ... response for significantly longer than patients treated with ziprasidone (p = 08) risperidone and quetiapine in large, randomized clinical trials measuring time to discontinuation for any cause...

Ngày tải lên: 11/08/2014, 16:23

... the variation in hemodynamic goals in clinical trials and whether this variation is associated with patient outcomes To better understand the hemodynamic goals in clinical trials in the sepsis research, ... shown) Discussion The present systematic review of hemodynamic goals in sepsis clinical trials has two major findings First, of the 126 clinical studies that were reviewed in full, 73% did not include ... clinical trials evaluating novel therapies in patients with sepsis did not specify hemodynamic goals of treatment • For those 13 studies identified in our systematic review, there was wide variation...

Ngày tải lên: 13/08/2014, 03:21

... balancing the children's rights to decision making with their ability to deal with the responsibilities that come with it and with the responsibilities of parents for the decision making of their ... information related to clinical trials The appreciation of children and adolescents and their parents of what a clinical trial involved and their reasoning about participation in a clinical trial ... deficit/hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) ADHD is characterized by impulsivity and inattention The main characteristic of ODD is noncompliance with the instructions...

Ngày tải lên: 13/08/2014, 18:21

... applied standard exclusion criteria in many antidepressant clinical trials (mainly psychiatric and substance abuse comorbidities or current suicidal ideation) to 293 patients who they had diagnosed ... clinicians Thus, it is typical for a clinical treatment study in psychiatry to be designed mainly 46 Chapter 8: Clinical trials to describe a change in depressive symptoms as a number (a continuous ... this specific patient who is African-American, male, 90 years old, with comorbid liver disease? Or, alternatively, is antidepressant X better than placebo in this specific patient who is white,...

Ngày tải lên: 01/11/2013, 11:20

... relative rarity of vulvar cancer, however, phase III trials are not practical Even phase II trials may often require Intergroup participation to permit accrual in timely fashion Five randomized phase ... mechanisms or the facilities to oversee trials in different countries The complexities associated with the EU directive on clinical trials poses a particular threat to exploratory or phase II studies; ... regulations Financial support for clinical trials The effective conduct of clinical trials requires a major commitment of time and other resources An ongoing commitment to clinical trials in gynecological...

Ngày tải lên: 13/02/2014, 07:20