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1 sion in rectal cancer patients enrolled in a phase I trial.
2 ponse was determined within the context of a phase I trial.
3 carboplatin had acceptable tolerability in a phase I trial.
4 cell or adenocarcinoma were treated on this phase I trial.
5 emonstrated therapeutic potential in a prior phase I trial.
6 e systemic dose range considered safe in the Phase I trial.
7 Fifteen patients enrolled onto this phase I trial.
8 Eleven patients were entered onto this phase I trial.
9 s preclinical study, the authors performed a phase I trial.
10 by the minimal toxicity and survival in this phase I trial.
11 of a ligand fusion-protein, DAB389IL-2, in a phase I trial.
12 enicity of RG7787 is now being assessed in a phase I trial.
13 patients with sarcoma in a disease-specific phase I trial.
14 lind, placebo-controlled, within-dose cohort phase I trial.
15 e-blind, placebo-controlled, dose-escalation Phase I trial.
16 and normal CEA levels were eligible for this phase I trial.
17 e-escalation and single-stage expansion of a phase I trial.
18 bilization for three or more courses in this phase I trial.
19 n was well tolerated by CLL patients in this phase I trial.
20 tively in upcoming Children's Oncology Group phase I trials.
21 termined by Monte Carlo simulation of 60,000 phase I trials.
22 tients was more frequent than predicted from phase I trials.
23 esponse rates are increasingly reported from phase I trials.
24 is and fatigue than was anticipated from the phase I trials.
25 feasibility of a novel two-stage design for phase I trials.
26 c indications, beginning with well-conducted phase I trials.
27 participation or of the research purpose of phase I trials.
28 -Hodgkin's lymphoma (NHL) in two concomitant phase I trials.
29 clinical trials but did not progress beyond phase I trials.
30 n the low likelihood of medical benefit from phase I trials.
31 should improve the safety and efficiency of phase I trials.
32 ing such designs to guide dose escalation in phase I trials.
33 RT to better select appropriate patients for phase I trials.
34 using a large patient database from multiple phase I trials.
35 es with survival, validating RECIST's use in phase I trials.
36 itors blocking this signaling cascade are in phase I trials.
37 al initiatives to assist communication about phase I trials.
38 selected cohort of 78 patients enrolled onto phase I trials.
39 g steps is the initiation of first-in-human (phase I) trials.
41 Forty-nine children were enrolled onto this phase I trial (24 with acute nonlymphoblastic leukemia [
45 er Therapeutics Evaluation Program-sponsored phase I trials activated between 2000 and 2010 was used.
46 dren with cancer (n = 85) who were offered a phase I trial along with their parents and physicians.
49 sults of our pilot study do not suggest that phase I trials always cost payers more than standard tre
51 ength of stay in the ICU was 3.7 days in the Phase I trial and a mean of 3 days in the Phase II trial
55 nging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are d
56 s about the emergence of multi-institutional phase I trials and about using the optimal biologic dose
57 tanding of either provided information about phase I trials and alternatives to trial participation o
58 s Perspectives, we highlight key elements of phase I trials and discuss how each one of them contribu
59 ly ethical concerns regarding the conduct of phase I trials and had realistic expectations of the pot
60 rent guidelines for the conduct of pediatric phase I trials and represents a consensus between Americ
63 tastases might be appropriately entered into phase I trials, and we present our approach for their st
65 This study was undertaken to determine how phase I trials are currently conducted and to provide a
67 atives to the standard design for conducting phase I trials are proposed with increasing frequency.
68 toxicity (DLT) help to assure that pediatric phase I trials are safely conducted and reliably identif
72 py), with those choosing to participate in a phase I trial being more optimistic than those declining
73 cted from 2,182 eligible patients treated in phase I trials between 2005 and 2007 in 14 European inst
74 mic studies are frequently incorporated into phase I trials, but it is uncommon that they guide dose
78 efficacy of EGFR inhibitors, we performed a phase I trial combining dasatinib, an SFK and multikinas
79 ltiply-relapsed B-cell NHL were treated in a phase I trial combining iodine-131 tositumomab (ranging
80 eriences with the interactive subject-choice phase I trial design and consent process, was conducted
83 f the traditional 3 + 3 patients per cohort, phase I trial design with a novel, rolling six design wa
84 recombinant human endostatin (rh-Endo) in a phase I trial designed to assess safety, pharmacokinetic
85 be used in combination with BCNU in another phase I trial designed to determine the maximal-tolerate
88 Many parents of children participating in phase I trials do not understand the purpose of these tr
94 Internet information and unproven therapies, phase I trial enrollment, and working as a multidiscipli
95 likely to agree that alternate care plans to phase I trial entry had been explained (odds, 2.5; P = .
102 e rate for one cycle of this therapy in this phase I trial for patients with leukemia was 18% (95% co
104 ral solid tumor types, and the initiation of phase I trials for A2AR antagonists in oncology, this ap
105 domains of diphtheria toxin, is presently in phase I trials for patients with resistant acute myeloid
106 e clinical solution to challenges arising in phase I trials from the dose-dependent side effects of t
110 Approximately 36% of patients enrolled onto phase I trials had mild renal dysfunction by FDA criteri
118 data, coupled with the observations of a new phase I trial in human peripheral atherosclerosis, sugge
121 een shown to possess antiviral activity in a phase I trial in patients chronically infected with geno
124 growth factor, is currently the subject of a Phase I trial in patients with ischemic heart disease.
125 These preclinical studies were followed by a phase I trial in patients with neoplastic meningitis.
128 e antitumor immune responses, we conducted a phase I trial in patients with surgically resected adeno
130 hicago who were eligible to participate in a phase I trial in which they underwent a three-step infor
132 including Roneparstat, a modified heparin in phase I trials in myeloma patients, significantly inhibi
133 Distinctive characteristics of pediatric phase I trials, in comparison to adult phase I trials, i
134 atric phase I trials, in comparison to adult phase I trials, include the necessity for multiinstituti
139 and in a patient with gastric cancer on the phase I trial led to this phase II study of flavopiridol
140 ree end-of-life decisions: enrollment onto a phase I trial (n = 7), adoption of a do not resuscitate
141 escribed here is a participant in an ongoing phase I trial (NCT00902044; active, not recruiting), and
142 server-blind, randomized, placebo-controlled phase I trial (NCT03300050), safety and immunogenicity o
144 odies and have permitted the initiation of a phase I trial of (211)At-labeled chimeric 81C6 administe
145 The purpose of this study was to conduct a phase I trial of (90)Y-DOTATOC to determine the dose-tox
153 vasculature of solid tumors, we performed a phase I trial of antibody J591, targeting the extracellu
159 and young adult subjects participating in a Phase I trial of defined composition CD19CAR T cells (NC
163 ive non-Hodgkin's lymphoma were treated on a phase I trial of dose escalation using the ProMACE-CytaB
164 enrolled on a prospective single-institution phase I trial of dose-escalated hypofractionated RT with
169 IL-2 regimen for testing this hypothesis, a phase I trial of IL-2 (Roche) was performed in children
170 he measured data in 10 of 14 patients in the phase I trial of intra-Ommaya radioimmunotherapy using (
171 udy, we report the results of a first-in-man phase I trial of intranodal direct injection (IDI) of Ad
179 reported up to 90% seroconversion rates in a phase I trial of live-attenuated dengue-virus vaccines i
191 gator-initiated single-dose, dose-escalation phase I trial of RTX in chronic dialysis patients (PRA >
193 The Children's Cancer Group conducted a phase I trial of temozolomide stratified by prior cranio
197 We present the results of the first human phase I trial of the Ii-Key hybrid HER-2/neu peptide (AE
204 es from breast cancer patients enrolled on a phase I trial of trastuzumab and IL-12, and found elevat
206 in the first 5 participants enrolled in this phase I trial of virus-based gene transfer in this mitoc
208 ta that have guided the design of subsequent phase I trials of ABT-888 in combination with DNA-damagi
209 s peptide to NOD mice prevents diabetes, and phase I trials of an altered peptide ligand of B:9-23 ar
211 ncer and Leukemia Group B conducted parallel phase I trials of cytarabine, daunorubicin, and etoposid
216 reclinical glioma models, and have initiated phase I trials of these vaccines in patients with malign
217 origin are used worldwide as xenografts, and phase I trials of viable pig pancreatic islets are curre
218 y and alternative medicine (CAM) usage among phase I trial participants and to describe these patient
220 communication and information sharing about phase I trial participation are often missing from inter
222 erstanding of possible risks and benefits of phase I trial participation, through direct subject invo
223 ts may provide useful supplementary data for phase I trials, particularly with regard to toxicity and
224 against the allogeneic donor.METHODSIn this phase I trial, patients received either 1.5 x 106 MICs p
229 and EMBASE, limiting studies to single-agent phase I trials recruiting adults and published after 200
230 all molecule inhibitor MLN4924, currently in phase I trials, represents an unprecedented opportunity
233 s a good predictor of clinical response?; in phase I trials should effective biological dose, not max
235 , and has moved at an unprecedented speed: a phase I trial started in March 2020 and there are curren
238 rties of imatinib were investigated during a phase I trial that included 64 adult patients with Phila
241 d from 82 patients entered in four different phase I trials that were previously reported as separate
242 studies demonstrated that in an HIV vaccine phase I trial, the DP6-001 trial, a polyvalent Env DNA p
247 administered as primary cancer therapy in a phase I trial to determine (1) whether mixed chimerism c
250 rexate (MTX) in lymphoblasts, we developed a phase I trial to determine the maximum-tolerated dose (M
255 designed as a single-blind, escalating-dose phase I trial to evaluate the safety and immunogenicity
257 bjects were inoculated in an adaptive-design phase I trial to rapidly identify colonizing doses of NT
260 d hypersensitivity reactions (HSRs), initial phase I trials used a 90-, 60-, 30-minute initial infusi
263 Receiving cytotoxic chemotherapy as part of phase I trial was also associated with shorter median OS
266 nd paclitaxel-resistant ovarian carcinoma, a phase I trial was conducted that combined increasing day
272 This National Cancer Institute-sponsored phase I trial was designed to determine the feasibility
282 re observed in kidney cancer patients in the phase I trials, we performed a phase II trial of flavopi
284 h the aim of improving patient selection for phase I trials, we previously performed a retrospective
286 eas 83% of UKCCSG respondents indicated that phase I trials were associated with ethical difficulties
289 Advanced cancer patients enrolling onto phase I trials were surveyed regarding biologically base
290 c, castration-resistant prostate cancer in a phase I trial where sequential cohorts were treated with
291 a novel treatment can be obtained in current phase I trials, which can therefore be considered to hav
294 ha-particle-emitting (211)At, we performed a phase I trial with intraperitoneal alpha-particle therap
298 ilot study the costs of care for patients on phase I trials with those incurred for standard treatmen
300 ty-nine patient-subjects participated in the phase I trial, with 24 who agreed to and completed the s