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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.
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
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
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
61 r patients were enrolled onto this two-stage phase II trial and were stratified by whether they had r
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
67 , while in the randomized placebo-controlled phase II trial, annualized relapse rates were 0.37 in th
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
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
80 ed analysis of data from 1,359 patients in 4 phase II trials assessed the effects of evolocumab, a fu
83 irect factor Xa inhibitors are emerging from phase II trials (betrixaban and YM150) and three are bei
88 and Methods This randomized (1:1) open-label phase II trial compared the efficacy of pazopanib 800 mg
90 based on small pilot studies with inadequate phase II trial data and limited mechanistic data to prov
96 ing time suggests that a multi-institutional phase II trial designed to evaluate clinical efficacy is
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
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
118 ity-modulated RT as part of an institutional phase II trial for localized primary brain tumors, inclu
120 valproic acid (VPA), currently undergoing a phase II trial for RP, has both beneficial and detriment
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
125 es, and is currently being tested in several phase II trials for treatment of major human cancers.
131 pectrum of HF, preliminary results from many phase II trials have been promising but are frequently f
134 ligible for enrollment onto this multicenter phase II trial if they had not received prior chemothera
138 al (PFS) in a randomized, placebo-controlled phase II trial in men with metastatic castration-resista
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
145 double-blind, placebo-controlled randomized phase II trial in patients with previously untreated, un
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
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
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
169 of hematologic malignancies, we conducted a phase II trial (NHL-001) of single-agent lenalidomide in
171 tients enrolled on a prospective multicenter phase II trial of BC before and after surgical treatment
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
180 ire was a coprimary end point of the pivotal phase II trial of gefitinib (Iressa; AstraZeneca, Wilmin
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
186 This study provides the foundation for a phase II trial of O6-BG plus temozolomide in temozolomid
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
194 nib, we performed a multicenter single-stage phase II trial of regorafenib in patients with advanced
197 of observed responses in a phase I trial, a phase II trial of romidepsin in patients with T-cell lym
200 utes to radiation resistance, we undertook a phase II trial of the EGFR inhibitor erlotinib with whol
205 We previously reported a dose-finding and phase II trial of the TI-CE regimen (paclitaxel [T] plus
212 TTG is a powerful end point for randomized phase II trials of cytotoxic therapies in metastatic col
214 al groups have achieved promising results in phase II trials of patient-specific idiotype vaccines, w
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
222 s, the probability of a positive or negative phase II trial predicting an effective or ineffective ph
225 y OGX-427, an antisense therapy currently in phase II trials, reduced tumor metastasis in a murine mo
229 AC, the Southwest Oncology Group initiated a phase II trial (S0126) to evaluate the EGFR tyrosine kin
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
235 oup B (Alliance) 50401 trial is a randomized phase II trial studying rituximab (375 mg/m(2) weekly fo
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
246 performed a multi-institutional prospective phase II trial to assess late toxicities in patients wit
248 Gynecologic Oncology Group (GOG) conducted a phase II trial to assess the efficacy and tolerability o
255 tyrosine kinases, we conducted an open-label phase II trial to determine the efficacy of sorafenib in
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
266 uated historical data from cooperative group phase II trials to attempt to develop benchmarks for OS
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
273 This multicenter, open-label, single-arm, phase II trial was conducted to assess the antitumor act
276 placebo-controlled, double-blind, randomized phase II trial was designed to assess the efficacy and s
280 l lung cancer (ES-SCLC) trials, a randomized phase II trial was initiated to evaluate the use of cisp
282 of this international, pivotal, single-arm, phase II trial was to confirm the efficacy of romidepsin
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
291 s; compared with the remaining trials, these phase II trials were more than 10 times more likely to o
295 with advanced nodal disease, we conducted a phase II trial with induction chemotherapy (ICT) consist
297 replicates) to simulate two-arm, randomized phase II trials with alpha = 0.10 (one sided) and 20 to
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
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