ライフサイエンスコーパス: phase II trial

1 recurring pancreatic cancer in a prospective phase II trial.

2 acizumab therapy in a randomized prospective phase II trial.

3 the bias on the estimated quantities from a phase II trial.

4 plasma samples collected from patients in a phase II trial.

5 provide intermediate-term follow-up on this phase II trial.

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

7 ith or without sorafenib in this multicenter phase II trial.

8 in this prospective, single-arm, multicenter phase II trial.

9 ly-stage NSCLC participating in a single-arm phase II trial.

10 to human IL2) in a Children's Oncology Group phase II trial.

11 mab treatment-in an open-label, multicenter, phase II trial.

12 eactivity to dnaJP1 were enrolled in a pilot phase II trial.

13 ative censoring using data from a randomized phase II trial.

14 of prognostic factors of the patients in the phase II trial.

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

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

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

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

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

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

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

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

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

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

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

26 oprotein (Lp)(a) from a pooled analysis of 4 phase II trials.

27 activity in small-cell lung cancer (SCLC) in phase II trials.

28 pe 9 (PCSK9), significantly reduced LDL-C in phase II trials.

29 ehyde thiosemicarbazone (3-AP)) is a drug in Phase II trials.

30 data from meta-analysis of Cooperative Group phase II trials.

31 afety and possible improved efficacy support phase II trials.

32 ics, and a PBD dimer (SJG-136, SG2000) is in phase II trials.

33 Such agents are currently in phase II trials.

34 studies from longitudinal tumor size data in phase II trials.

35 or OS and PFS as reference points for future phase II trials.

36 s compared with outcomes from two historical phase II trials.

37 h vaccine and high-dose IL-2 in any of three phase II trials.

38 s, a dose of 12.5 mg/d is being evaluated in phase II trials.

39 t product, Hemospan, is currently undergoing phase II trials.

40 in as potential agents to be investigated in phase II trials.

41 Alzheimer's, and anti-Abeta mAbs are now in phase II trials.

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

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

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

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

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

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

48 In a phase II trial, 60 patients with recurrent malignant ast

49 were obtained for patients enrolled onto 42 phase II trials (70 trial arms) that completed accrual i

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

51 A phase II trial adding rituximab to a low-dose cyclophosp

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

53 r knowledge, this is the first international phase II trial aimed at clarifying Cp prevalence and act

54 retastatin has shown activity in phase 1 and phase II trials; although the registration phase III stu

55 Given the desire for control arms in phase II trials, an increasing number of experimental th

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

57 r patients were enrolled onto this two-stage phase II trial and were stratified by whether they had r

58 Several phase II trials and a single, large phase III trial have

59 veral drugs that received AA on the basis of phase II trials and for which confirmatory trials were i

60 er, summarizes efficacy and safety data from phase II trials and historical studies of bevacizumab in

61 combination regimens have shown efficacy in phase II trials and there is no comparative study betwee

62 negative rates (beta errors) in up to 25% of phase II trials and up to 42% of phase III trials.

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

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

65 , while in the randomized placebo-controlled phase II trial, annualized relapse rates were 0.37 in th

66 The treatments prioritized in a phase II trial are then tested definitively against a co

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

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

69 Before proceeding to phase III, randomized phase II trials are often used to decide whether the new

70 Phase II trials are used to show sufficient preliminary

71 the efficacy of KIR-mismatched NK cells in a phase II trial as consolidation therapy to decrease rela

72 e describes the issues by using two oncology phase II trials as examples, evaluates the impact of the

73 This open-label, randomized phase II trial assessed efficacy and tolerability of two

74 This phase II trial assessed the activity and tolerability of

75 This international phase II trial assessed the activity of ixabepilone in p

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

77 This phase II trial assessed the efficacy and safety of a com

78 ed analysis of data from 1,359 patients in 4 phase II trials assessed the effects of evolocumab, a fu

79 In a phase II trial assessing response to everolimus, 31 men

80 Phase II trials assessing repurposed agents must conside

81 This phase II trial, AVF3752g (PASSPORT), specifically addres

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

83 irect factor Xa inhibitors are emerging from phase II trials (betrixaban and YM150) and three are bei

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

85 Randomized or single-arm phase II trials can provide insight into the range of ef

86 Phase II trials clearly demonstrate the activity of sing

87 Preliminary results of a phase II trial combining an anti-IGF-1R monoclonal antib

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

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

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

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

92 based on small pilot studies with inadequate phase II trial data and limited mechanistic data to prov

93 These phase II trial data support the use of canakinumab as a

94 This phase II trial demonstrated increased patient survival c

95 A previous phase II trial demonstrated that the fully human anti-IL

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

97 preclinical models, in addition to improving phase II trial design.

98 This was a two-stage phase II trial design.

99 ing time suggests that a multi-institutional phase II trial designed to evaluate clinical efficacy is

100 A return to endorsing phase II trial designs for AA for oncology NMEs, particu

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

102 randomized, double-blind, placebo-controlled phase II trial enrolled 178 patients with cirrhosis, inc

103 The study was a single-center, open-label phase II trial, enrolling 10 participants with bilateral

104 The study was a single-center, open-label phase II trial, enrolling 11 participants with bilateral

105 To allow comparisons across phase II trials, enrollment criteria may need to be rest

106 This open-label, randomized phase II trial evaluated CI-1033 in patients with advanc

107 This single-center, open-label, phase II trial evaluated the bortezomib, pegylated lipos

108 This phase II trial evaluated the effect of neoadjuvant chemo

109 This phase II trial evaluated the safety and efficacy of comb

110 This phase II trial evaluated the safety and efficacy of yttr

111 A multicenter, randomized phase II trial evaluated the safety of combining bevaciz

112 This randomized phase II trial evaluated two different immunostimulants

113 This randomized phase II trial evaluated vintafolide combined with pegyl

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

115 This phase II trial evaluated whether complete clinical respo

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

117 ctal cancer were prospectively included in a phase II trial evaluating the combination of irinotecan

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

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

120 Multiple phase II trials evaluating ixabepilone in different popu

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

122 This global, randomized phase II trial examined erlotinib plus tivantinib (ARQ 1

123 We evaluated a phase II trial for efficacy.

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

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

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

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

128 In a small, prospective phase II trial for women with completely resected stage

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

130 Objective tumor response rates observed in phase II trials for metastatic melanoma have historicall

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

132 In a prospective phase II trial, four of 10 pediatric patients with sarco

133 ear and important role for PRO assessment in phase II trials going forward.

134 In a randomized phase II trial, granulocyte-macrophage colony stimulatin

135 If our phase II trials had been a single, multiarm trial using

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

137 gnant mesothelioma (MM), although single-arm phase II trials have reported variable outcomes.

138 ligible for enrollment onto this multicenter phase II trial if they had not received prior chemothera

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

140 and efficacy of pentostatin in a prospective phase II trial in corticosteroid-refractory cGVHD.

141 cific efficacy against clinical malaria in a phase II trial in Malian children.

142 other cancers and demonstrated activity in a phase II trial in MBC.

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

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

145 inotecan, and bevacizumab (FOLFIRI + B) in a phase II trial in patients previously untreated for meta

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

147 umab (GA101) were explored in our randomized phase II trial in patients with heavily pretreated DBLCL

148 dian survival of 8.8 months in a multicenter phase II trial in patients with metastatic pancreatic ca

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

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

151 double-blind, placebo-controlled randomized phase II trial in patients with previously untreated, un

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

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

154 Following a phase II trial in which pemetrexed-platinum demonstrated

155 Several phase II trials in advanced soft tissue sarcoma patients

156 Phase II trials in different GI malignancies have distin

157 oration of efficacy and safety is ongoing in phase II trials in newly diagnosed and first-relapse pat

158 ibitor saracatinib (AZD0530) is currently in phase II trials in patients including those with colorec

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

160 promising clinical efficacy in nonrandomized phase II trials in patients with ovarian cancer with BRC

161 Two phase II trials in patients with previously-treated adva

162 development in EOC, emphasizing the role of phase II trials in patients with recurrent disease and i

163 The recommended dose of ixabepilone for phase II trials in solid tumors is 8 mg/m(2)/d daily for

164 This randomized phase II trial investigated two dosing schedules of etir

165 We performed a multi-center phase II trial investigating the safety and efficacy of

166 Additional phase II trials investigating the dose and timing of cal

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

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

169 r progression-free survival observed in this phase II trial is comparable to results observed with fi

170 uate the efficacy of a cytostatic agent in a phase II trial is more relevant than clinical response b

171 A phase II trial is ongoing.

172 To the best of our knowledge, this phase II trial is the first prospective multicenter ILI

173 A multicenter phase II trial is underway treating patients to 50 Gy in

174 The recommended dose/schedule for phase II trials is decitabine 90 mg/m2 (day 1) followed

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

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

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

178 hs after adjuvant chemoradioimmunotherapy in phase II trials motivated the present study.

179 of hematologic malignancies, we conducted a phase II trial (NHL-001) of single-agent lenalidomide in

180 We report on a multicenter phase II trial of (90)yttrium-ibritumomab-tiuxetan ((90)

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

182 We performed a phase II trial of bevacizumab, a monoclonal antibody to

183 ecurrent glioblastoma patients enrolled in a phase II trial of cediranib, an oral pan-VEGF receptor t

184 We conducted a phase II trial of conformal radiation therapy (CRT) to e

185 Following completion of a phase II trial of elesclomol in combination with paclita

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

187 This phase II trial of enzastaurin was conducted to determine

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

189 We conducted a phase II trial of extended-dose temozolomide (TMZ) in pa

190 We conducted a phase II trial of high-dose bolus (HDB) interleukin-2 (I

191 A phase II trial of iadademstat in combination with azacit

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

193 A previous report of a randomized phase II trial of imatinib mesylate in patients with inc

194 A neoadjuvant randomized phase II trial of LHRHa with AA was conducted in patient

195 In an investigator-initiated phase II trial of OFA plus chemotherapy for chronic lymp

196 An open-label, multicenter, randomized, phase II trial of oral ridaforolimus compared with proge

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

198 ent of patients with synovial sarcoma on the phase II trial of pazopanib had no evidence of disease p

199 We report, to our knowledge, the first phase II trial of pomalidomide administered in combinati

200 We conducted a phase II trial of preoperative gemcitabine and cisplatin

201 This is a noncomparative, randomized, phase II trial of preoperative taxane-anthracycline in c

202 nib, we performed a multicenter single-stage phase II trial of regorafenib in patients with advanced

203 Preliminary results of a phase II trial of rituximab in multiple sclerosis sugges

204 of observed responses in a phase I trial, a phase II trial of romidepsin in patients with T-cell lym

205 In this phase II trial of sorafenib in patients with advanced MT

206 utes to radiation resistance, we undertook a phase II trial of the EGFR inhibitor erlotinib with whol

207 We conducted a phase II trial of the EGFR TKI erlotinib in previously u

208 We conducted a phase II trial of the SFK inhibitor dasatinib for advanc

209 We previously reported a dose-finding and phase II trial of the TI-CE regimen (paclitaxel [T] plus

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

211 A phase II trial of this regimen is ongoing.

212 A randomized phase II trial of two novel treatment strategies in the

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

214 Here, we describe a randomized, phase II trial of weekly topotecan with or without ziv-a

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

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

217 erged as an important inclusion criterion in phase II trials of targeted anticancer agents.

218 In this single-arm, phase II trial, patients received bevacizumab plus erlot

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

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

221 This study was designed as an open-label phase II trial performed in 4 hospitals in The Netherlan

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

223 This study was designed as an open-label phase II trial, performed in four hospitals in the Nethe

224 s single-institution participation, positive phase II trial, pharmaceutical company-based trials, and

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

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

227 y OGX-427, an antisense therapy currently in phase II trials, reduced tumor metastasis in a murine mo

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

229 ceded by encouraging preclinical studies and phase II trial results of the same therapy.

230 Phase II trial S0204 was designed to improve survival re

231 observed in single-arm studies (scenario 1), phase II trials (scenario 2A/2B), and phase III trials (

232 In the presence of a putative biomarker, the phase II trial should also provide information as to wha

233 A randomized phase II trial showed significant benefit for gemcitabin

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

235 In a phase II trial, standard radiotherapy was delivered in d

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

237 A recent pilot study and subsequent phase II trial suggest that tumor necrosis factor (TNF)

238 Phase II trials suggested that weekly paclitaxel might b

239 Our phase II trial tested the efficacy and safety of enzasta

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

241 We report a phase II trial testing the combination of cetuximab with

242 is more likely to be a better endpoint for a phase II trial than a culture result at a single time po

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

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

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

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

247 This was a phase II trial to assess flurpiridaz F 18 for safety and

248 (A Phase II Trial to Assess Hemodynamic Effects of Istaroxi

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

250 We conducted a phase II trial to assess the activity and tolerability o

251 Gynecologic Oncology Group (GOG) conducted a phase II trial to assess the efficacy and tolerability o

252 A phase II trial to assess the efficacy of cilengitide the

253 We conducted this phase II trial to assess the efficacy of JS1/34.5-/47-/g

254 We conducted a phase II trial to assess the outcomes of patients who re

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

256 We conducted this phase II trial to determine the efficacy of erlotinib in

257 tyrosine kinases, we conducted an open-label phase II trial to determine the efficacy of sorafenib in

258 We conducted a multi-institution phase II trial to evaluate a novel 21-day schedule of ir

259 A phase II trial to evaluate efficacy using 2,000 mg twice

260 We conducted a phase II trial to evaluate the benefit of capecitabine i

261 We conducted a phase II trial to evaluate the efficacy and safety of si

262 We report an international, multicenter phase II trial to evaluate the efficacy and toxicity of

263 A multicenter randomized phase II trial to evaluate two treatment strategies in t

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

265 and Leukemia Group B conducted a randomized phase II trial to investigate two novel chemotherapy reg

266 tient cohort of 174 patients enrolled onto a phase II trial to provide a more complete assessment of

267 e for (131)I were enrolled onto a single-arm phase II trial to receive axitinib orally (starting dose

268 We performed a randomized phase II trial to test the hypothesis that inhibitors of

269 uated historical data from cooperative group phase II trials to attempt to develop benchmarks for OS

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

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

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

273 A single-arm, multicenter, phase II trial was conducted in patients with Eastern Co

274 This multicenter, open-label, single-arm, phase II trial was conducted to assess the antitumor act

275 A phase II trial was conducted to evaluate the antitumor a

276 placebo-controlled, double-blind, randomized phase II trial was designed to assess the efficacy and s

277 This phase II trial was designed to define the role of O(6)-b

278 This randomized phase II trial was designed to select a cetuximab plus c

279 A Fleming phase II trial was designed.

280 A phase II trial was performed to determine clinical activ

281 of this international, pivotal, single-arm, phase II trial was to confirm the efficacy of romidepsin

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

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

284 In a multicenter, double-blind phase II trial, we compared the efficacy and safety of p

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

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

287 phase III trials should take precedence over phase II trials, we argue that there is a clear and impo

288 ree survival (PFS) as an endpoint for future phase II trials, we evaluated historical data from coope

289 Two parallel, phase II trials were conducted to evaluate the response

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

291 s; compared with the remaining trials, these phase II trials were more than 10 times more likely to o

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

293 76 assessable patients were treated on this phase II trial, which included six cycles of PE.

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

295 4 costimulatory pathway has just completed a phase II trial with a CNI-free arm.

296 with advanced nodal disease, we conducted a phase II trial with induction chemotherapy (ICT) consist

297 Randomized phase II trials with a time-to-progression endpoint are

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

299 Phase II trials with biochemotherapy (BCT) have shown en

300 and reasonable tolerability in a multicenter phase II trial, with RR of 41%, well in excess of single