ライフサイエンスコーパス: phase II trial

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

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

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

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

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

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

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

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

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

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

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

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

13 gent for further evaluation of efficacy in a phase II trial.

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

15 ine therapy were enrolled onto a multicenter phase II trial.

16 e 1 or 2, were eligible for this multicenter phase II trial.

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

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

19 acizumab therapy in a randomized prospective phase II trial.

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

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

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

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

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

25 afety and possible improved efficacy support phase II trials.

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

27 Such agents are currently in phase II trials.

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

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

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

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

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

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

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

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

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

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

38 otein kinase C beta (PKCbeta) inhibitor, for phase II trials.

39 on the magnitude of activity demonstrated in phase II trials.

40 performed to determine a dose for subsequent phase II trials.

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

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

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

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

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

46 In this phase II trial, 100 mCi of 131I-m81C6 was injected direc

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

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

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

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

51 e Radiation Therapy Oncology Group initiated phase II trial 9514 to evaluate its neoadjuvant regimen

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

53 r, a higher percentage of women recruited to phase II trials accepted.

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

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

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

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

58 latinum agents have demonstrated activity in phase II trials among patients with recurrent platinum-r

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

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

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

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

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

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

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

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

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

68 We are now conducting a phase II trial, approved by the US Food and Drug Adminis

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

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

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

72 Phase II trials are used to show sufficient preliminary

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

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

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

76 This phase II trial assessed the activity and tolerability of

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

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

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

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

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

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

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

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

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

92 This phase II trial demonstrated increased patient survival c

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

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

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

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

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

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

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

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

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

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

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

104 This phase II trial evaluated the effect of neoadjuvant chemo

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

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

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

108 This randomized phase II trial evaluated two different immunostimulants

109 This randomized phase II trial evaluated vintafolide combined with pegyl

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

111 This phase II trial evaluated whether complete clinical respo

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

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

114 herapy Oncology Group (RTOG) is conducting a phase II trial evaluating the multi-institutional feasib

115 Multiple phase II trials evaluating ixabepilone in different popu

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

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

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

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

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

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

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

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

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

125 es, and is currently being tested in several phase II trials for treatment of major human cancers.

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

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

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

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

130 A randomized phase II trial has completed accrual.

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

132 Phase II trials have demonstrated the activity of bevaci

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

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

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

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

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

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

139 Response data support a phase II trial in neuroblastoma.

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

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

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

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

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

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

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

147 Several phase II trials in advanced soft tissue sarcoma patients

148 Phase II trials in different GI malignancies have distin

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

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

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

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

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

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

155 This phase II trial included two cohorts of patients.

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

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

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

159 eral institutions are engaged in phase I and phase II trials investigating the therapeutic potential

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

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

162 A phase II trial is ongoing.

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

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

165 our reliance on the results of well-designed phase II trials is critical.

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

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

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

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

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

171 tients enrolled on a prospective multicenter phase II trial of BC before and after surgical treatment

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

173 We offered results to 135 participants in a phase II trial of breast excision alone for women with d

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

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

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

177 This phase II trial of enzastaurin was conducted to determine

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

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

180 ire was a coprimary end point of the pivotal phase II trial of gefitinib (Iressa; AstraZeneca, Wilmin

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

182 alation trial in 40 healthy volunteers and a phase II trial of HPV16 L2E7E6 at the maximum dose in 29

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

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

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

186 This study provides the foundation for a phase II trial of O6-BG plus temozolomide in temozolomid

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

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

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

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

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

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

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

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

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

196 This was a prospective phase II trial of rituximab plus fractionated cyclophosp

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

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

199 0 patients at two sites were enrolled onto a phase II trial of sorafenib plus IFN-alpha-2b.

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

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

202 A phase II trial of the OMV vaccine, MenBvac, with proven

203 A phase II trial of the oral epidermal growth factor recep

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

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

206 pic immunomodulatory effects, we conducted a phase II trial of this agent in CLL.

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

208 A phase II trial of this regimen is ongoing.

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

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

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

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

213 Numerous phase II trials of novel combinations have yielded promi

214 al groups have achieved promising results in phase II trials of patient-specific idiotype vaccines, w

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

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

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

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

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

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

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

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

223 This prospective phase II trial provides additional evidence that this fa

224 In a recent phase II trial, recombinant activated factor VII (eptaco

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

226 were dose-finding trials, and a mere 20% of phase II trials reported a statistical design.

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

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

229 AC, the Southwest Oncology Group initiated a phase II trial (S0126) to evaluate the EGFR tyrosine kin

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

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

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

237 Phase II trials suggested that weekly paclitaxel might b

238 intervention research are exemplified using phase II trials targeting cognitive impairment.

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

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

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

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

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

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

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

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

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

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

249 We conducted a phase II trial to assess the efficacy and tolerability o

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

267 In this prospective phase II trial, topotecan was administered intravenously

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

269 phase I trial, we carried out a prospective phase II trial using stereotactic body radiation therapy

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

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

272 A one-stage phase II trial was conducted in postmenopausal women wit

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

274 A phase II trial was conducted to determine if high-dose r

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 l lung cancer (ES-SCLC) trials, a randomized phase II trial was initiated to evaluate the use of cisp

281 A phase II trial was performed to determine clinical activ

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

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

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

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

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

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

288 te the value realized from including PROs in phase II trials, we provide case examples from cancer tr

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

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

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

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

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

299 e has been a long-standing interest in using phase II trials with randomization against a standard-tr

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