ライフサイエンスコーパス: phase II

1 remission rate within the first two cycles (phase II).

2 ed 49 patients in phase I and 44 patients in phase II.

3 phase I or II and none has progressed beyond phase II.

4 required step for the peptide to progress to phase II.

5 nals are required to signal the beginning of phase II.

6 In phase II, 19 additional patients were treated at the max

7 phase I (1987 to 1990), over 18 months, and phase II (1990 to 1995), over 36 months, were undertaken

8 In phase II, 53 patients were treated.

9 d, placebo-controlled, crossover, randomized phase II-a trial of nonischemic cardiomyopathy patients

10 d, placebo-controlled, crossover, randomized phase II-a trial of nonischemic cardiomyopathy patients

11 in preclinical animal models for MS and in a phase II acute optic neuritis clinical trial (RENEW).

12 d by the vaccine regimen.IMPORTANCE A failed phase II AIDS vaccine trial led to the hypothesis that C

13 mbles the atomic arrangement of both gallium phase II and III (the high pressure crystalline phase).

14 Recent results from phase II and III clinical trials in mCRC demonstrate tha

15 encouraging and support the setup of larger phase II and III clinical trials to assess the efficacy

16 eeks, which is the dose and schedule used in phase II and III studies and now approved for patients w

17 ultiple sclerosis (RRMS) in Europe, which in phase II and III studies demonstrated superior efficacy

18 iled and reviewed publications of subsequent phase II and III trials citing the original phase I biom

19 tment and has been successfully evaluated in phase II and III trials for patients with Crohn's diseas

20 Methods Data were pooled from phase II and III trials of patients who received nivolum

21 ) who did not achieve SVR after treatment in phase II and III trials of SOF regimens.

22 ulsion(R); NeuroSTAT(R)) are being tested in phase II and III trials respectively and NeuroSTAT(R) re

23 outhwest Oncology Group database to identify phase II and III trials that included taxane therapy fro

24 likely to pass successfully through clinical phases II and III trials (and preclinical work) and not

25 LiMn1.5Ni0.5O4 (Phase I), Li0.5Mn1.5Ni0.5O4 (Phase II) and Mn1.5Ni0.5O4 (Phase III).

26 days (acute phase I) and 8 to 10 days (acute phase II), and some of them at 4 to 6 months (chronic ph

27 able to inhibit GSK3beta and induce the Nrf2 phase II antioxidant and anti-inflammatory pathway at mi

28 spin transition stabilizes the high-pressure phase II at much lower pressure conditions than its Mg-r

29 f linear OCS (R3m, Phase I) to bent OCS (Cm, Phase II) at 9 GPa; an amorphous, one-dimensional (1D) p

30 conceivable that the low-spin ferromagnesite phase II becomes a major deep-carbon carrier at the deep

31 The results from the randomized phase II BELOB trial provided evidence for a potential b

32 erapy versus D monotherapy in the randomized phase II BRF113220 study part C.

33 exes and have both undergone preclinical and Phase II clinical development for the treatment of AD.

34 galeterone, which has successfully completed phase II clinical development in men with castration res

35 istant parasitic strains, as attested by the phase II clinical development of ferroquine, with a new

36 with 1 (BMS-582949), a previously disclosed phase II clinical p38alpha MAP kinase inhibitor, a struc

37 eclinical safety profile and is currently in phase II clinical studies for the treatment of depressio

38 GDC-0810 is currently being evaluated in Phase II clinical studies in women with ER+ breast cance

39 A phase II clinical trial evaluating the effects of good m

40 A phase II clinical trial evaluating the effects of good m

41 radiotracer, Flurpiridaz F 18, has undergone phase II clinical trial evaluation as a high-resolution

42 Chinese herb gamboges, has been approved for Phase II clinical trial for cancer therapy by Chinese FD

43 We conducted a single-arm phase II clinical trial of single-agent platinum for mTN

44 In a phase II clinical trial that treated 27 patients with me

45 ) burn were prospectively randomized in this Phase II clinical trial to either metformin or insulin (

46 We performed an open-label, single-arm phase II clinical trial to investigate the efficacy and

47 lpha-(18)F-fluoroestradiol ((18)F-4FMFES), a phase II clinical trial was initiated to compare the PET

48 Forty-four patients were enrolled in this Phase II clinical trial, 18 metformin and 26 insulin pat

49 (131)I-MIBG) and tested the combination in a phase II clinical trial.

50 with inflammatory breast cancer treated in a Phase II clinical trial.

51 ive metastatic breast cancer in a randomized phase II clinical trial.

52 tibody yielded little efficacy in a previous phase II clinical trial.

53 tered to 38 patients with 45 infections in a phase II clinical trial.

54 th resin (90)Y-microspheres in a prospective phase II clinical trial.

55 y difficult to gather enough children into a phase II clinical trial.

56 Compound 1 is currently in phase II clinical trials for advanced solid tumors and r

57 from phase III clinical trials in adults and phase II clinical trials in children and adolescents dem

58 We also describe preliminary findings from phase II clinical trials in patients treated with miR-12

59 ized in the 1990s and has recently completed Phase II clinical trials in patients with leukaemia and

60 Phase II clinical trials inform go/no-go decisions for p

61 Larger and longer phase II clinical trials of anastrozole may be warranted

62 phosphate and serine pro-drug forms is under phase II clinical trials.

63 Here, we present the results of the phase II component of a phase I/II study that evaluated

64 , basal cytochrome P450 (CYP450) activities, phase II conjugation, drug-mediated CYP450 induction, an

65 sionally make therapeutic decisions based on phase II data.

66 utathione S-transferase alpha 4 (GSTA4) is a phase II detoxifying enzyme that metabolizes electrophil

67 ibited one: (i) more removal from the liquid phase; (ii) deviation from first-order kinetics for the

68 h stable-isotope labeled DNAN to confirm ten phase II DNAN metabolites in Arabidopsis.

69 nd efficacy, and to identify the recommended phase II dose (RP2D) of PT2385.

70 The recommended phase II dose (RP2D) was determined on the basis of safe

71 aximum tolerated dose (MTD), the recommended phase II dose (RP2D), and the schedule, safety, pharmaco

72 The primary end point was the recommended phase II dose (RP2D).

73 ntly reached, and therefore, the recommended phase II dose for subsequent clinical trials was only te

74 4 days is being evaluated as the recommended phase II dose in dose-expansion cohorts for patients wit

75 The recommended phase II dose is MK-8776 200 mg plus gemcitabine 1,000 m

76 The recommended phase II dose of 35 mg/m(2) given twice a week was chose

77 okinetics, pharmacodynamics, and recommended phase II dose of MK-8776 (SCH 900776), a potent, selecti

78 etermine safety, toxicity, and a recommended phase II dose regimen of LY2606368, an inhibitor of chec

79 The recommended phase II dose was established as abexinostat 45 mg/m(2)

80 The recommended phase II dose was indicated in 34 studies (41%), but in

81 In the phase II dose-ranging study, each dose of netupitant (co

82 o phase III clinical trials and a randomized phase II dose-ranging study.

83 (XPO1/CRM1), and determined the recommended phase II dose.

84 ed; DL2 was determined to be the recommended phase II dose.

85 with robust preclinical evidence, have solid phase II dosing and timing data, and recruit patients wh

86 Of greatest concern is the lack of adequate phase II dosing and timing studies when rushing from pro

87 At phase II, down-regulation of numerous iron-containing pr

88 ography (LC) and MS, to generate phase I and phase II drug metabolites and to demonstrate protein mod

89 sferases (GSTs) comprise a diverse family of phase II drug metabolizing enzymes whose shared function

90 The primary phase II end point was improved ORR.

91 The primary phase II end point was the 2-year overall survival (OS)

92 needed to clarify the potential of TTG as a phase II end point.

93 factor erythroid-related factor 2 (NRF2) and phase II enzyme pathway components were found to act as

94 n multifunctional stress protein acting as a Phase II enzyme, activating cancer pro-drugs and stabili

95 s increased elimination of plasma T4 through Phase II enzymes.

96 ndomized, double-blinded, placebo-controlled phase II evaluation of the pharmacokinetics of ABZ (15 m

97 A phase II expansion is ongoing.

98 During acute phase II, favorable recovery from neglect was associated

99 Phase II flavonol metabolites (0.2%) derived mainly from

100 ganglia, locus coeruleus, and raphe nuclei (phase II), followed by primary motor cortex and precereb

101 This phase II/III clinical trial compared talactoferrin with

102 h factor receptors 1, 2, and 3, currently in phase II/III clinical trials.

103 mineralocorticoid receptor antagonist are in phase II/III of development, while inhibitors of aminope

104 Purpose LUME-Meso is a phase II/III randomized, double-blind trial designed to

105 Future phase II/III studies are warranted to elucidate the surv

106 Across the phase II/III studies of SOF, HCV samples were genotyped

107 andomized, double-blind, placebo-controlled, phase II/III study with 12 months of follow-up.

108 s North American Intergroup Study S1117 is a phase II/III trial that randomly assigned patients with

109 ical trials, a quarter of which have reached phase II/III.

110 In the phase II IM103-100 study, kidney transplant recipients w

111 This is the beginning of phase II, in which oil microdroplets quickly nucleate in

112 ggesting that a significant component of the phase II increase in ventilation is mediated by ATP acti

113 the AIDS Malignancy Consortium) conducted a phase II Intergroup clinical trial that used early inter

114 Asthma Genetics in Childhood Study (MAGICS)/Phase II International Study of Asthma and Allergies in

115 oxidized the reduced glutathione (GSH) pool, phase II iron limitation exhibited transient resistance

116 hort-term (<3 d, phase I) and chronic (>5 d, phase II) iron limitation.

117 Phase II is OR-dependent and concludes as OSN axons coal

118 In the single-arm, phase II KEYNOTE-055 study, we evaluated pembrolizumab,

119 Across both the Phase I and Phase II libraries, 62% of the chemicals were classified

120 tection Agency's (EPA's) ToxCast Phase I and Phase II libraries, which contain 292 and 676 chemicals,

121 ells in the natural environment resemble the phase II metabolic state.

122 s are extensively metabolized by phase I and phase II metabolism (which occur predominantly in the ga

123 ng sulforaphane identified the modulation of phase II metabolism, reactive oxygen species clearance,

124 Acting during phase II metabolism, sulfotransferases (SULTs) serve det

125 nolol and its hydroxypropranolol glucuronide phase II metabolites from a rat thin tissue section was

126 The untargeted detection of phase II metabolites is a key issue for the study of dru

127 Different phase I and phase II metabolites of the pesticides were identified i

128 oferulic and dihydrocoumaric acids and their phase II metabolites, in addition to feruloylglycine, po

129 lso critical in elimination of liver-derived phase II metabolites, particularly those undergoing gluc

130 se animals presented higher levels of plasma phase-II metabolites as well as altered microbial metabo

131 itivity; however, inherent expression of the phase II-metabolizing enzyme sulfur transferase 1A1 does

132 In this single-arm, phase II, multi-institutional study, 92 patients with bi

133 This randomized phase II multicenter trial evaluated cabozantinib compar

134 l Study of Asthma and Allergies in Childhood Phase II, n = 1446 total subjects, n = 763 asthmatic pat

135 l Study of Asthma and Allergies in Childhood Phase II, n = 3557 total subjects, n = 281 asthmatic pat

136 We conducted a multicenter randomized phase II neoadjuvant trial of carboplatin and nanopartic

137 r, it remains unknown if avirulent Nine Mile phase II (NMII) can infect and replicate in B1a cells an

138 with the biosafety level 2 (BSL2) Nine Mile phase II (NMII) clone 4 strain of C. burnetii, as a mode

139 Nine Mile phase II (NMII) strain.

140 vasive fungal infection (IFI), a prospective phase II noncomparative trial was performed at our cente

141 ntified 33 AMI metabolites (both Phase I and Phase II), occurring mostly in bile, liver and plasma.

142 In a phase II open label single center noncomparative clinica

143 In a phase II open label single center noncomparative clinica

144 This phase II open-label trial was conducted to evaluate safe

145 st cancer brain metastases in a multicenter, phase II open-label trial.

146 graphic response as the primary end point in phase II osteosarcoma trials may limit optimal detection

147 LL in a phase I dosage-escalation part and a phase II part, using 6-week treatment cycles.

148 Among 744 phase I and 2,382 phase II participants randomized to sodium reduction or

149 dal efficacy data obtained during a previous phase II pharmacokinetic study that compared combined AB

150 Materials and Methods A phase II prospective clinical trial of the poly-(adenosi

151 Conclusion To our knowledge, our phase II prospective study offers one of the shortest co

152 We conducted a multicenter, phase II, prospective, cooperative group study (coordina

153 We performed a phase II randomised controlled crossover trial of low-do

154 2-arm parallel phase II randomised controlled trial with blind assessme

155 In this phase II randomised crossover trial, low-dose fish oil w

156 Phase II randomized clinical trials of CRS-207 as a boos

157 A phase II randomized, double-blind, placebo-controlled, a

158 We performed a phase II randomized, placebo-controlled, double-blinded

159 In this phase II, randomized placebo-controlled multicenter stud

160 Phase II, randomized, open-label study in which particip

161 Comparing Endocrine Treatments (FIRST) was a phase II, randomized, open-label, multicenter trial.

162 phase III study was conducted to confirm the phase II results and to detect an overall survival (OS)

163 Phase II results are reported here.

164 st clinical trial enterprise and encouraging phase II results, the vast minority of oncologic drugs i

165 In phase II, Ser/Thr dehydration (TclKL) and peptide macroc

166 We reviewed phase II single-agent studies (570 studies; 32,149 patie

167 le-blind, placebo-controlled, parallel-group phase II single-center study.

168 Comprehensive analysis of phase II, single-agent arms revealed that, across malign

169 er Informed Treatment of Atrial Fibrillation phase II) sites.

170 Phase II solid tumor trials have traditionally used end

171 Two phase II studies assessed the efficacy of vismodegib, a

172 We conducted a systematic search of phase II studies conducted between 1999 and 2004 and com

173 Adequate dose-finding phase II studies do not exist.

174 Phase II studies with biomarker evaluation are ongoing.

175 Purpose Considering promising results in phase II studies, a randomized phase III trial was desig

176 al ramifications for the predictive value of phase II studies.

177 nderstanding of the implications of positive phase II studies.

178 more effective design and interpretation of phase II studies.

179 We used data from a phase II study (AOST0221) of patients with osteosarcoma

180 In this phase II study (NCT00942747), temsirolimus was tested in

181 n-label, multicenter (n = 13), parallel-arm, phase II study , 43 patients with HG BCG-refractory or r

182 This phase II study demonstrates that BeGEV is an effective s

183 This prospective, multicenter phase II study did not specify the therapeutic regimen,

184 ied in the phase Ib portion (n = 7), and the phase II study enrolled 106 evaluable patients (n = 53 i

185 Patients and Methods This open-label phase II study enrolled adults with Ph(+) ALL who had re

186 This open-label randomized phase II study evaluated progression-free survival (PFS)

187 This multicenter, open-label, phase II study evaluated the combination of bendamustine

188 report results of a single-arm, multicenter, phase II study evaluating the safety and efficacy of sav

189 A single-agent phase II study examining a 200-mg dose given once every

190 The phase II study GO27819 investigated the monovalent MET i

191 Our previous phase II study had shown the efficacy of induction chemo

192 This was a prospective phase II study in adults 18 to 59 years old with previou

193 We conducted a proof-of-principle phase II study in patients with p53 tumor suppressor gen

194 eliminary diagnostic efficacy data from this phase II study indicate that (68)Ga-OPS202 has high sens

195 n this article on page 1043.This multicenter phase II study investigated a selective radiotherapy dos

196 This phase II study investigated the activity of glembatumuma

197 This phase II study investigated the combination of TriMixDC-

198 A phase II study of ATG+G-CSF in patients with new-onset t

199 This phase II study of AUY922 and erlotinib did not meet its

200 e compared in this randomized, double-blind, phase II study of men with CRPC.

201 l mechanisms of this benefit, we conducted a phase II study of neoadjuvant bevacizumab (single dose)

202 A phase II study testing ASK1240, that is, anti-CD40 antib

203 trial was a randomized, placebo-controlled, phase II study that enrolled patients before chemotherap

204 hological findings of the sentinel case in a phase II study that led to clinical development disconti

205 We conducted a two-center phase II study to determine the safety of hemithoracic i

206 We performed a phase II study to evaluate the efficacy and safety of pe

207 This phase II study was conducted to further investigate the

208 The goal of this phase II study was to evaluate the efficacy of this comb

209 patients who received cetuximab as part of a phase II study were associated with high expression of t

210 This phase II study with ER+ breast cancer patients showed th

211 In a randomized Phase II study, adding olaratumab to doxorubicin chemoth

212 In this phase II study, intracoronary nitrite infusion did not a

213 and Methods In this multicenter, randomized, phase II study, patients with asymptomatic PCa were elig

214 In this double-blind, phase II study, patients with metastatic pancreatic canc

215 In this phase II study, patients with MF or SS with negligible t

216 In this phase II study, we investigated the efficacy and safety

217 ment resolution in a randomized, multicenter phase II study.

218 ly reported efficacy and safety data for the Phase II study.

219 F (mDCF) regimen in a randomized multicenter phase II study.

220 and therapeutic efficacy were evaluated in a phase II study.

221 ted therapy were enrolled in this single-arm phase II study.

222 lone in patients with advanced melanoma in a phase II study.

223 patients with recurrent glioblastoma in this phase II study; however, further investigation into biom

224 by a secondary depression (to a steady-state phase II) that can be life-threatening in premature infa

225 accurately allow defining (i) the infection phase, (ii) the infecting parasite strains, and (iii) or

226 In phase II, the objective response rate was 85.7%.

227 a, suggesting that comparison of phase I and phase II titers could be reexamined as a surveillance cr

228 Methods We searched ClinicalTrials.gov for phase II to IV cancer trials of Food and Drug Administra

229 uing via low-intensity shifting cultivation (phase II), to today's global integration, dominated by i

230 l Study of Asthma and Allergies in Children) Phase II tools.

231 A pivotal phase II trial (METRIC [Metastatic Triple-Negative Breas

232 we report the final results of a multicenter phase II trial addressing a new treatment for secondary

233 bo (GP) in a multicenter phase Ib/randomized phase II trial and preclinical PC models.

234 This phase II trial assessed the antitumor activity, dose-res

235 and Methods This randomized (1:1) open-label phase II trial compared the efficacy of pazopanib 800 mg

236 A randomized phase II trial comparing the PD-L1 inhibitor atezolizuma

237 This phase II trial evaluated the effect of neoadjuvant chemo

238 This phase II trial evaluated volasertib or single-agent chem

239 This phase II trial evaluated whether complete clinical respo

240 ity-modulated RT as part of an institutional phase II trial for localized primary brain tumors, inclu

241 nd other neurodegenerative disorders, with a phase II trial for RP under way.

242 valproic acid (VPA), currently undergoing a phase II trial for RP, has both beneficial and detriment

243 al (PFS) in a randomized, placebo-controlled phase II trial in men with metastatic castration-resista

244 drug that was well tolerated in a 6 wk-long phase II trial in patients with epilepsy, is a promising

245 We conducted a prospective phase II trial in patients with pPCL to assess the effic

246 We conducted a two-institution phase II trial of everolimus and letrozole in women with

247 adiation Therapy Oncology Group RTOG-0630 (A Phase II Trial of Image-Guided Preoperative Radiotherapy

248 -hydroxycamptothecin (SN-38), in an expanded phase II trial of patients with relapsed or refractory m

249 chemotherapy-refractory mCRC in a randomized phase II trial of this rare molecular subtype.

250 A phase II trial of this regimen is ongoing.

251 kar et al. (2014) report findings of a small phase II trial performed in Indian patients with chronic

252 s, the probability of a positive or negative phase II trial predicting an effective or ineffective ph

253 oup B (Alliance) 50401 trial is a randomized phase II trial studying rituximab (375 mg/m(2) weekly fo

254 performed a multi-institutional prospective phase II trial to assess late toxicities in patients wit

255 We designed a Phase II trial to assess whether a neurocritical care ma

256 The primary end point of the phase II trial was complete plus partial response rate.

257 A Fleming phase II trial was designed.

258 The aim of this randomized, phase II trial was to explore the activity and safety of

259 The purpose of this randomized phase II trial was to investigate the efficacy and toxic

260 4 costimulatory pathway has just completed a phase II trial with a CNI-free arm.

261 this prospective, international, multicenter phase II trial, 152 treatment-naive adult solid organ tr

262 nd Methods In this prospective, neoadjuvant, phase II trial, 375 patients with early breast cancer wi

263 ), a 2 x 2 factorial, open-label, randomized phase II trial, evaluated the impact of adding carboplat

264 In this randomized, open-label phase II trial, postmenopausal women with newly diagnose

265 In this open-label randomized phase II trial, the main end point was progression-free

266 Patients and Methods In this single-center phase II trial, treatment-naive patients received everol

267 ponses in two subjects that were part of the phase II trial.

268 promising and will be further explored in a phase II trial.

269 issues, and warrants further assessment in a phase II trial.

270 to assess the benefit of MDT in a randomized phase II trial.

271 (CRLM) were included in a single-institution phase II trial.

272 -arm, single-stage, open-label, multicenter, phase II trial.

273 s evaluated in 43 patients in a prospective, phase II trial.

274 for baseline tumor burden were fit for each phase II trial: absolute changes, relative changes, and

275 se III trials, and appropriate end points in phase II trials are critical for facilitating this decis

276 We simulated phase II trials by resampling patients from N9741, a ran

277 Herein, we report data from 2 phase II trials evaluating the effect of repeated cycles

278 are based on doxycycline (doxy), already in phase II trials for Alzheimer's disease, covalently link

279 that can be used as a comparison for future phase II trials for recurrent osteosarcoma.

280 pectrum of HF, preliminary results from many phase II trials have been promising but are frequently f

281 Phase II trials in different GI malignancies have distin

282 The optimal end point for randomized phase II trials of anticancer therapies remains controve

283 TTG is a powerful end point for randomized phase II trials of cytotoxic therapies in metastatic col

284 Single-arm phase II trials required an 8%-115% greater sample size

285 However, hypothesis-generating data from phase II trials that reveal an association between incre

286 In all, 317 phase II trials were identified and followed for a media

287 In all, 2,000 phase II trials were simulated from four actual phase II

288 replicates) to simulate two-arm, randomized phase II trials with alpha = 0.10 (one sided) and 20 to

289 feasible surrogate end points are needed for phase II trials.

290 /refractory osteosarcoma in these single-arm phase II trials.

291 s of combinations have not progressed beyond phase II trials.

292 to predict phase III outcomes from simulated phase II trials.

293 In this phase II, unblinded trial 182 patients in 22 centers wer

294 TARGET: Stroke phase II was launched in April 2014 with a goal of promo

295 abel, dose-ranging, crossover study (COMPACT Phase II) was conducted in 18 patients with type I or II

296 cal dormancy is conferred by preventing full phase-II water uptake of the encased non-dormant seed.

297 In phase II, we combine targeted sequencing on another 28 t

298 tacts with dendritic cells before entering a phase II, where they exist in stable clusters with dendr

299 use of the most active agents determined in phase II window studies, and use of irinotecan as a radi

300 hase I) transforms to an orthorhombic phase (Phase II with Pmm2 space group) at approximately 50 GPa