ライフサイエンスコーパス: phase II

1 CT SFA phase I) and NCT01566461 (IN.PACT SFA phase II).

2 h nabilone or switch to placebo for 4 weeks (phase II).

3 n fall at a rate similar to the experimental phase II.

4 phase I and 1220 of 1347 features (90.6%) at phase II.

5 phase I, and to 1.4% (95% CI 0.9-2.2) after phase II.

6 at phase I and 19 of 1347 features (1.4%) at phase II.

7 phase I and 703 of 1075 features (65.4%) at phase II.

8 mg and bevacizumab 15 mg/kg were chosen for phase II.

9 significant results in phase III compared to phase II.

10 In phase II, 15 teams computed values for 1347 derived feat

11 minute resting state at baseline (room air); phase II, 6-minute maternal hyperoxia with 100% oxygen;

12 (61.5% reduction) and to 67 per 1,000 during phase II (65.6% overall reduction).

13 In phase II, a six-marker MDM panel (homeobox A1 [HOXA1], e

14 t-hoc of a double-blind, placebo-controlled, phase II-a study in patients with episodic migraine rece

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

16 r outpatient administration, the recommended phase II activity was established at 2.96 GBq/m(2).

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

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

19 views, all reported CVD events across latter-phase (II and III) trials supporting FDA approval of ant

20 A pivotal phase II and a confirmatory phase III study are ongoing.

21 In this multicenter phase II and biomarker study, we evaluated the efficacy

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

23 individual-level data from GlaxoSmithKline's Phase II and III clinical trials of the monovalent rotav

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

25 Data from 9 Phase II and III clinical trials, assessing the efficacy

26 out a systematic review and meta-analysis of phase II and III randomized controlled trials on bempedo

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

28 States has followed the European example for phase II and III studies; no formal US Food and Drug Adm

29 inconclusive, or possibly falsely negative, Phase II and III trial outcomes in neurological diseases

30 Multiple phase II and III trials are ongoing for these combinatio

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

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

33 Patients treated with ibrutinib in phase II and III trials provided the discovery data set

34 ribution of P values of primary outcomes for phase II and phase III drug trials reported to the Clini

35 tionally disordered Phase I; broken-symmetry Phase II and reentrant melt curve.

36 demonstrated that boundary Theta(2) between phases II and III predicted Psi at leaf turgor loss.

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

38 n Survey (NHANES) II, NHANES III Phase I and Phase II, and 1999-2016 continuous NHANES were used to d

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

40 Glucuronidation, a common phase II biotransformation reaction, is one of the major

41 nsus spectra, which appear to originate from Phase II biotransformation reactions.

42 In the Phase II borderline-resectable trial (NCI# 01591733) coh

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

44 to GLPG1205 identification, currently under phase II clinical investigation, are described herein.

45 Phase II clinical testing in ERBB2 exon 20-mutant non-sm

46 in 56 patients treated in the CheckMate 205 phase II clinical trial (NCT02181738).

47 for glioblastoma, we conducted a single-arm phase II clinical trial (NCT02550249) in which we tested

48 ls, with one compound currently undergoing a Phase II clinical trial and another that recently garner

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

50 NF1 Patients were recruited from a phase II clinical trial for the treatment of PN.

51 Anti-Nogo-A therapy has entered phase II clinical trial in humans and might therefore so

52 This study was a single-centre, phase II clinical trial of AHSCT for patients with activ

53 SARC024 is a phase II clinical trial of the multikinase inhibitor reg

54 A double blind, randomized, single center phase II clinical trial was conducted comparing placebo

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

56 In a 2012 Phase II clinical trial, 300 Bangladeshi children aged 2

57 In this double-masked, randomized, phase II clinical trial, 45 patients (aged 35 +/- 15 yea

58 rrier and to be safe and well tolerated in a Phase II clinical trial.

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

60 findings, we evaluated the pattern from two phase II clinical trials evaluating neoadjuvant chemothe

61 pective cohorts of patients derived from two phase II clinical trials evaluating patients treated wit

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

63 Minnelide is currently in Phase II clinical trials for treatment of advanced pancr

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

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

66 Phase II clinical trials show promising data with anakin

67 plasma Ang 1-7 and lowered Ang II levels in phase II clinical trials.

68 PC patients receiving SPA as part of ongoing Phase II clinical trials.

69 t is equivalent to the number of patients in phase II clinical trials.

70 In the subsequent Phase II, coalescence elevates the molecular complexity

71 In the preplanned phase II cohort expansion, the primary objective was obj

72 metastatic anaplastic thyroid carcinoma in a phase II cohort of the study.

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

74 Phase II consisted of an expansion cohort of 76 patients

75 early-stage breast cancer patients from the Phase-II D-BEYOND clinical trial (NCT01864798) is well t

76 transferase alpha4 (GSTA4), a member of the Phase II detoxifying enzyme superfamily, mediates reduct

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

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

79 se I study, so 3 ug/kg every 2 weeks was the phase II dosage.

80 The recommended phase II dose (RP2D) for once- or twice-weekly administr

81 AAML1421 sought to determine the recommended phase II dose (RP2D) of CPX-351 and the response rate af

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

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

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

85 ary objective was to establish a recommended phase II dose (RP2D).

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

87 cohort, establishing the MTD and recommended phase II dose at lenvatinib 20 mg/d plus pembrolizumab.

88 86S has acceptable safety at the recommended phase II dose level of 2.4 mg/kg once every 3 weeks.

89 The recommended phase II dose of AZD1775 was 150 mg/d.

90 We report the recommended phase II dose of T-DM1 3.6 mg/kg and neratinib 160 mg/d

91 lowed by cohort expansion at the recommended phase II dose or weekly (0.8 to 1.0 mg/kg).

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

93 as not established; however, the recommended phase II dose was identified as 1.25 mg/kg.

94 at week 24 (ORR(week 24)) at the recommended phase II dose.

95 er AZD1775 administration at the recommended phase II dose.

96 two patients were treated at the recommended phase II dose: venetoclax 600 mg per day orally in 28-da

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

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

99 In a phase II double-blind, placebo-controlled study, we test

100 This phase II, double-blind, randomized, placebo-controlled,

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

102 The primary phase II end point was improved ORR.

103 istic inhibition of membrane transporter and phase II enzyme function.

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

105 levels of endothelial NOS (eNOS), Nrf2, and Phase II enzymes (heme oxygenase-1, catalase, superoxide

106 led during phase Ib (n = 13) and the initial phase II expansion (n = 124).

107 rt results from the dose-finding and initial phase II expansion of a phase Ib/II study of lenvatinib

108 val benefit in breast cancer, we conducted a phase II feasibility study of trastuzumab and pertuzumab

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

110 US) enzymes cause drug toxicity by reversing Phase II glucuronidation in the gastrointestinal tract.

111 The phase II HORIZON trial evaluated the efficacy of melfluf

112 ronavirus 2 (SARS-CoV-2) and is currently in phase II/III clinical trials (NCT04405570 and NCT0440573

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

114 ndary analysis of the prospective randomized phase II/III European Organization for Research and Trea

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

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

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

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

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

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

121 Phase II: in 8 swine, right atrial lines were created in

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

123 Phase II interventions were not associated with a level

124 In this multicenter, open-label, randomized phase II investigator-sponsored neoadjuvant trial with f

125 t is in Phase I, thereby indicating that the Phase II is more mature.

126 i-CD8 tracer, which is currently in clinical phase II, is a promising monitoring tool for intratumora

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

128 t from the 2-cohort-locally advanced and R/M-phase II KEYNOTE-629 study.

129 In the Phase II locally-advanced trial (NCI# 01821729) cohort o

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

131 reduce P450 metabolite formation, impacts on phase II metabolism and hepatocyte protein expression sh

132 is study was to characterize the absorption, phase II metabolism and microbial catabolism of querceti

133 Membrane permeability, phase II metabolism, and ATP binding cassette (ABC) memb

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

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

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

137 tem for phenolic catabolites and their human phase II metabolites is proposed in this article and the

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

139 to determine whether anthocyanins and their phase II metabolites permeate the blood-cerebrospinal fl

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

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

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

143 hile predawn Psi continued to decline during phase II (moderate drought), and midday and predawn Psi

144 In this phase II multicenter trial (ClinicalTrials.gov identifie

145 This randomized phase II multicenter trial evaluated cabozantinib compar

146 r-free days in patients with ARDS.Methods: A phase II, multicenter randomized controlled trial in adu

147 nt of advanced disease were enrolled in this phase II, multicenter trial and randomly assigned to rec

148 We conducted a phase II, multicenter trial to assess the efficacy and s

149 et Transplantation consortium 01 study was a phase II, multicenter, open label, active control, rando

150 This study was a phase II, multicenter, open-label study of two dose coho

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

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

153 With the completion of phase II of the B10K ("Bird 10,000 Genomes") consortium'

154 ing 267 newly sequenced genomes produced for phase II of the Bird 10,000 Genomes (B10K) Project.

155 This supplement presents findings from Phase II of the study (2016-2019) on burden of disease,

156 nding study of mFOLFIRINOX plus PEGPH20, the phase II open-label study randomly assigned patients (1:

157 In this phase II, open-label study, patients with relapsed/refra

158 I-SPY 2 is a multicenter, phase II, open-label, adaptively randomized neoadjuvant

159 of predefined criteria were evaluated in the phase II part of the study, the primary end point of whi

160 Arms B and D were selected for the phase II part of the study.

161 ated C. burnetii Nine Mile phase I (PIV) and phase II (PIIV) vaccines derived from axenic culture 7,

162 We conducted a randomized, double-blind, Phase II placebo-controlled trial of a monoclonal antibo

163 This was a phase II placebo-controlled, double-blind, parallel-grou

164 A phase II plasma study was then performed in 95 HCC cases

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

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

167 2-arm parallel phase II randomised controlled trial with blind assessme

168 This phase II, randomised, double-blind, placebo-controlled,

169 In a phase II randomized clinical trial, to assess whether 6

170 This combination will be evaluated in a phase II randomized controlled trial for locally advance

171 We conducted a phase II randomized trial of romiplostim versus untreate

172 PALLET is a phase II randomized trial that evaluated the effects of

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

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

175 We report the results of a phase II, randomized, open-label, single-center trial in

176 A Phase II, randomized, placebo-controlled, dose-finding t

177 We used a randomized phase II screening design with a primary end point of ov

178 The study had a phase II selection that was design to detect a 15% diffe

179 ve focal mass drug administrations (rfMDAs) (phase II, September 2017-June 2018) were deployed with a

180 owed that the balance between Phase I versus Phase II SHM activities impacts the resulting Ig phenoty

181 ved a lower frequency in mutations involving Phase II SHM DNA repair activities in older males, but n

182 The phase II single-arm KEYNOTE-052 study evaluated the effi

183 A phase II single-arm multicenter cooperative-group trial

184 EV-201 is a global, phase II, single-arm study of enfortumab vedotin 1.25 mg

185 ned patients to targeted therapy in parallel phase II studies based on tumor molecular alterations.

186 yses, randomized controlled trials, and some phase II studies published from 2005 through 2018.

187 Phase II studies with biomarker evaluation are ongoing.

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

189 tient populations for anetumab ravtansine in phase II studies.

190 ting that the antigens are eligible to enter Phase-II studies.

191 ixty-one patients treated in a nonrandomized phase II study (BRANCH) with concomitant or sequential (

192 g favorable trial endpoints in a prospective Phase II study (NCT01402284).

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

194 In a previous phase II study an immunonutrient supplement was found to

195 This randomized phase II study defines safety and response rate of epige

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

197 This phase II study evaluated the PD-L1 inhibitor avelumab in

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

199 The phase II study GO27819 investigated the monovalent MET i

200 cted an international multicenter randomized phase II study in 60 centers between December 2013 and N

201 European clinical trial authorization for a phase II study in a homogeneous patient cohort, with rep

202 uble-blind, placebo-controlled, dose-ranging phase II study in adults with symptomatic nHCM (New York

203 1beta, has also shown promising results in a phase II study in recurrent/refractory pericarditis.

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

205 S1505 (NCT02562716) was a randomized phase II study of perioperative chemotherapy with mFOLFI

206 studies (a phase I risankizumab study and a phase II study of risankizumab vs ustekinumab) were anal

207 We conducted a phase II study of ruxolitinib in 44 patients (21 CNL and

208 Encouraging data from the phase II study resulted in the FDA granting accelerated

209 These data provide the basis for an ongoing phase II study to better define the activity of this reg

210 atients with advanced ACC were enrolled in a phase II study to evaluate the clinical activity of pemb

211 ials and Methods This prospective single-arm phase II study was conducted between January 2015 and Ja

212 A randomized, phase II study was performed in patients with AEGC to ex

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

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

215 laparib Expanded, an investigator-initiated, phase II study, assessed olaparib response in patients w

216 In this phase II study, FFR-guided rate-response programming det

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

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

219 ge, 61 years; 33 males) were accrued for the phase II study.

220 hich depletes antibodies, was effective in a phase II study.

221 ic castration-resistant prostate cancer in a phase II study.

222 were enrolled in a multicenter, open-label, phase II study.

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

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

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

226 1 of 30 treatments in parallel, single-arm, phase II subprotocols.

227 The correlation is more regulated in Phase II than it is in Phase I, thereby indicating that

228 ted, and the correlation becomes stronger in Phase II than Phase I.

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

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

231 Only 15% of drugs advance from Phase II to approval, with ineffective targets accountin

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

233 tamol PET and corresponding MR images from a phase II trial (<em>n</em> = 70), including subjects ran

234 randomized, placebo-controlled, double-blind phase II trial (SORMAIN; German Clinical Trials Register

235 and Methods Enrollment for this prospective phase II trial began November 2011 and concluded January

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

237 INFORM is a randomized, multicenter, phase II trial comparing pathologic complete response (p

238 A Simon two-stage phase II trial design was used to distinguish between Re

239 This open-label, global phase II trial enrolled 129 patients (median age, 65 yea

240 This phase II trial evaluated whether complete clinical respo

241 Objectives: To conduct a phase II trial evaluating the hypothesis that early low-

242 We conducted a phase II trial evaluating the multitargeted tyrosine kin

243 We evaluated a phase II trial for efficacy.

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

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

246 , was found to be safe, yet ineffective in a phase II trial for type 2 diabetes.

247 We conducted a Phase II trial in 30 children with visceral leishmaniasi

248 ProCAID was a placebo controlled randomized phase II trial in mCRPC.

249 dy was a multicenter, open-label, multi-arm, phase II trial in patients with PI3K pathway-activated g

250 This is a French multicenter randomized phase II trial in patients with resectable high-risk T3,

251 o-to-one randomized, controlled, open-label, phase II trial in patients with untreated RAS wild-type

252 activity with low toxicity in a prospective phase II trial involving 30 men with metastatic castrate

253 activity with low toxicity in a prospective phase II trial involving 30 men with metastatic castrati

254 CITN-10 is a single-arm, multicenter phase II trial of 24 patients with advanced MF or SS.

255 To this end, we conducted a phase II trial of enzalutamide treatment (160 mg/d) in 3

256 A phase II trial of iadademstat in combination with azacit

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

258 A randomized, controlled, Phase II trial of Vi-TCV co-administration with the vacc

259 MC1273 was a single-arm phase II trial testing an aggressive course of RT de-esc

260 CLARITY is a phase II trial that combined ibrutinib with venetoclax i

261 CheckMate 568 is an open-label phase II trial that evaluated the efficacy and safety of

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

263 open-label, randomized, multicenter, two-arm phase II trial to investigate cisplatin and gemcitabine

264 A Fleming phase II trial was designed.

265 A randomized, phase II trial with a 2 x 2 factorial design was conduct

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

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

268 phase III randomized controlled trials, one phase II trial, and 16 retrospective studies met the inc

269 In this phase II trial, patients with LACC (International Federa

270 In this open-label phase II trial, patients with resected stage IA to IIIA

271 In this phase II trial, treatment volumes were reduced by omitti

272 In this phase II trial, we evaluate neoadjuvant enzalutamide and

273 In this multicenter phase II trial, we evaluated atezolizumab combined with

274 ients enrolled in our investigator-initiated phase II trial.

275 90)Y-DOTATOC in the setting of a prospective phase II trial.

276 ohort D of this multicenter, noncomparative, phase II trial.

277 s was intention to treat in a noncomparative phase II trial.

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

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

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

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

282 90)Y-DOTATOC in the setting of a prospective phase II trial.

283 recurring pancreatic cancer in a prospective phase II trial.

284 Data from phase I and phase II trials are already available for several vaccin

285 Phase II trials assessing repurposed agents must conside

286 from three Indonesian randomized controlled phase II trials comparing oral rifampicin 450mg (~10mg/k

287 se-developed biologics, have been studied in phase II trials in patients with EoE; and (3) novel diet

288 he long-term follow up data of 2 prospective phase II trials is reported (NCT00072033, NCT00445861),

289 of efficacy between proof-of-concept (i.e., Phase II trials) and pivotal, confirmatory (Phase III tr

290 ted with rucaparib 600 mg twice daily in the phase II TRITON2 study.

291 In phase II, using a rapid cycle improvement approach, we t

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

293 The primary end point for phase II was overall response rate (ORR).

294 termine the OBD of methotrexate, and that of phase II was to determine the 3-month progression-free s

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

296 In phase II, we implemented a set of pilots to simulate a m

297 therapy (phase Ib) or were treatment naive (phase II) were enrolled.

298 Arylamine N-acetyltransferase 1 (NAT1) is a phase II xenobiotic-metabolizing enzyme that also has a

299 n all tissues, is classically described as a phase-II xenobiotic metabolizing enzyme but can also cat

300 mphoma (LBCL) on the basis of the single-arm phase II ZUMA-1 trial, which showed best overall and com