ライフサイエンスコーパス: DLT

1 DLT at the starting dose of 12 mg/m(2)/d resulted in de-

2 DLT caused by myelosuppression was seen in two of six pa

3 DLT criteria were revised to permit management of GI tox

4 DLT for HCC is feasible and achieves equivalent results

5 DLT in later courses included pleural effusions, hemangi

6 DLT is neurologic.

7 DLT occurred in 3 patients at 157 mg/m2, including nause

8 DLT occurred in one of six patients at 1,470 mg/m2 and t

9 DLT patients had more major complications (23.7% vs 13.0

10 DLT using livers from familial amyloidotic polyneuropath

11 DLT was defined as a 2-week delay in radiotherapy for gr

12 DLT was not observed with a fixed dose of 85 mg/m2 given

13 DLT was not observed.

14 DLT was observed in one of six patients at 300 mg (rash)

15 DLT was reached at level 3 (bevacizumab 5 mg/kg, FU 800

16 DLT was seen in six of 10 patients in the pancreatic stu

17 DLTs (grade 3 nausea, vomiting, fatigue in one; hyperten

18 DLTs (grade 4 neutropenia for > 5 days and grade 3 fatig

19 DLTs (grade 4 thrombocytopenia) was noted in two of the

20 DLTs (n = 40 total events) were principally fatigue (35%

21 DLTs at 431 mg/m(2) were grade 3 bilirubin (n = 1), AST

22 DLTs at 53 mg/m(2)/d for 3 days included hyperglycemia w

23 DLTs at doses above the 1.04-mg/m(2) MTD attributed to P

24 DLTs comprised elevated hepatic enzymes, hypophosphatemi

25 DLTs consisted of hypertensive crisis, congestive heart

26 DLTs include neuropathy, fatigue, and diarrhea.

27 DLTs included diarrhea (n = 1), mucositis (n = 1), and e

28 DLTs included grade 3 diarrhea (n = 1), prolonged grade

29 DLTs included grade 4 thrombocytopenia, prolonged grade

30 DLTs included hypercalcemia at 15 mg/m(2); hypophosphate

31 DLTs included reversible, asymptomatic T-wave inversions

32 DLTs observed with the combination of 13cRA and vorinost

33 DLTs occurred in two mild group patients (600 and 800 mg

34 DLTs were diarrhea, rash, and mucositis on the troxacita

35 DLTs were hepatic transaminitis, hyperbilirubinemia, and

36 DLTs were HFS, rash, and mucositis on the troxacitabine

37 DLTs were increased ALT/AST (n = 1), dizziness, confusio

38 DLTs were reported in five of six patients receiving OTX

39 DLTs were typhlitis, diarrhea, and mucositis, and the MT

40 Cohort 1 DLT included diarrhea and neutropenia.

41 With imatinib and docetaxel, cycle 1 DLT was found in three of 12 patients at docetaxel 30 mg

42 MTD was defined at 0.8 mg/kg with 1 DLT observed (sepsis).

43 ting toxicity (DLT), constituting four of 10 DLTs.

44 was 12.0 Gy/fx; it was associated with 7.2% DLTs and high rates of tumor control.

45 At doses higher than 2.4 mg/m(2), DLT granulocytopenia was observed.

46 romidepsin was safe, well tolerated, with 3 DLTs across all schedules (grade 3 oral mucositis x 2; g

47 wo patients were treated at 0.5 mg/kg, and 4 DLTs occurred, including 2 irAEs and 2 with fatal GVHD.

48 No grade 3 or 4 DLTs occurred in 108 infusions, and no patient had syste

49 Four DLTs occurred in three of 40 DLT-evaluable patients (diarrhoea and hyperglycaemia in

50 A DLT and additional grade 2 toxicities made the 4,370-mg

51 Grade 4 hemorrhage, identified as a DLT, occurred in one patient in each of cohorts 2 and 3.

52 and the number still at risk of developing a DLT.

53 for toxicity in stratum I, one experienced a DLT (diarrhea) at 520 mg/m(2) twice daily, and all three

54 ing dose finding, 1/6 patients experienced a DLT (grade 3 decrease in ejection fraction).

55 xceeded; two of three patients experienced a DLT (grade 3 sensory neuropathy and febrile neutropenia)

56 was 12.0 Gy/fx, which had a probability of a DLT of 7.2% (95% CI, 2.8% to 14.5%).

57 g was resumed at 400 mg, and four additional DLTs were observed: G4 neutropenia and G4 thrombocytopen

58 ced FAP disease but not before 6 years after DLT.

59 second part of the study defined the MTD and DLT in acute leukemia.

60 nitial part of the study defined the MTD and DLT in solid tumors.

61 observed earlier, which defined the MTD and DLT.

62 pants enrolled was 22 (range, 11 to 33), and DLTs occurring per study was three (range, 0 to 5).

63 th rash, diarrhea, and fatigue identified as DLTs.

64 reas all levels above the MTD had an average DLT rate of 36%.

65 The average DLT rate was 18%, which is lower than in previous report

66 ned-modality therapy was well tolerated, but DLT prevented OXP and 5-FU escalation.

67 ving donor liver transplantation followed by DLT for MSUD is a complex procedure and demands technica

68 ezomib dose exceeds the conventional ceiling DLT rate of 20% to 33%.

69 d diarrhea) appears to be the major combined DLT.

70 Diarrhea was the most common DLT.

71 ing schedules, with diarrhea the most common DLT.

72 The most common DLTs were neutropenia, stomatitis/pharyngitis, myalgia,

73 After adjusting for potential confounders, DLT and cadaveric LT had a similar 5-year survival rate

74 A relatively constant DLT rate at the 70, 90, and 115 mg/m2/dose levels result

75 The primary endpoint was first-cycle DLTs.

76 Doses were then adjusted to define DLT for each combination.

77 rs, dose-limiting toxicity (DLT) definition, DLT rate, patient-dose allocation, overdose, underdose,

78 nine patients treated at 700 mg/d developed DLT (reversible grade 3 diarrhea); grade 3 and 4 events

79 Only one patient developed DLT (grade 3 diarrhea) at dosage level 5.

80 At 3 mg/d, two of 19 patients developed DLT; one patient had grade 3 thrombocytopenia and grade

81 At 260 mg/m(2)/dose, DLTs occurred in two of six patients, both of whom exper

82 At higher doses, DLTs were observed using both dosing schedules, with dia

83 until the first dose-limiting toxic effect (DLT) and by 50% thereafter, in keeping with a 3+3 clinic

84 level, only one of six patients experienced DLT (neutropenia > 7 days).

85 110 mg/m(2), two of six patients experienced DLT including grade 2 diarrhea and headache.

86 No re-treated patients experienced DLT.

87 eiving 1,150 mg/m(2) twice daily experienced DLTs (one each of rash, diarrhea, and fatigue).

88 uable for toxicity in stratum II experienced DLTs of rash at 900 mg/m(2) twice daily.

89 Two patients experienced DLTs (one each in the 80 mg and 600 mg dose groups).

90 Five patients experienced DLTs; MTD was 12.0 Gy/fx, which had a probability of a D

91 cities were captured: 46% of patients' first DLTs and 88% of dose reductions or discontinuations of t

92 he *1/*28 genotype, the MTD was 700 mg (five DLTs per 22 patients), and 850 mg was not tolerated (fou

93 Four DLTs occurred in three of 40 DLT-evaluable patients (dia

94 the *1/*1 genotype, the MTD was 850 mg (four DLTs per 16 patients), and 1,000 mg was not tolerated (t

95 atients), and 850 mg was not tolerated (four DLTs per six patients).

96 ients were enrolled at 12 mg/m(2)/d; one had DLT (grade 3 diarrhea).

97 line phosphatase; three of five patients had DLT at 3,300 mg/m2: grade 3 AST/ALT (n = 1), grade 4 bil

98 In cohort 2, one of seven patients had DLT at 75 mg.

99 uated (70 mg/m(2)), zero of six patients had DLT.

100 At 17 mg/m(2)/d, two of four patients had DLTs (grade 3 nausea; intolerable grade 2 fatigue).

101 However, DLTs occurred at levels 2 and 1A.

102 contain a pentameric VIDLT ((V/I/L/F/Y)(V/I)DLT) core sequence that is also found in the SIMs in PIA

103 If DLT was hematologic, less-heavily pretreated patients we

104 chemoradiotherapy and gefitinib (cohort II), DLTs included one grade 4 diarrhea and one grade 4 neutr

105 we describe our experience in 11 cases of LD-DLT in MSUD, highlighting the technical aspects of LD-DL

106 UD, highlighting the technical aspects of LD-DLT.

107 patocellular carcinoma (HCC) with Domino LT (DLT) using the "Double Piggy-back" technique.

108 The main DLT was peripheral neuropathy evident at the higher dose

109 totoxicity, and two had VOD, without meeting DLT criteria.

110 Most DLT occurred in patients with high PEG-IFN-lambda exposu

111 Two of nine DLTs were at the highest dose level.

112 No DLT occurred with 24-hour continuous infusion.

113 No DLT was encountered in cohort 3 with 12 patients at 150

114 No DLT was observed at 10 mg/m(2)/wk.

115 No DLT was recorded until 160 mg/day, when one patient had

116 th baseline neuropathy more than grade 1, no DLT occurred through 1.88 mg/kg (the phase II dose).

117 For patients with MM, no DLT was observed and MTD was not identified at up to 75

118 in cohorts of three to six patients when no DLT was identified.

119 No DLTs occurred at level 1.

120 No DLTs occurred in the three patients enrolled at 200 mg/m

121 No DLTs were observed in six patients in stratum one at sor

122 No DLTs were observed in the 1,500-mg cohort.

123 No DLTs were observed in the doses up to and including 80 m

124 No DLTs were observed in the subsequent dose-de-escalation

125 No DLTs were observed up to the maximum proposed dose of 20

126 No DLTs were observed, and thus, the MTD was not estimated.

127 ne patient on 150 mg three times weekly); no DLTs were reported in patients on the 5/2 schedule.

128 ar to historical controls, and there were no DLTs.

129 Treatment was well tolerated with no DLTs observed.

130 nd three more patients were enrolled with no DLTs.

131 000 mg per day in twice-daily dosing with no DLTs; however, plasma lapatinib concentrations plateaued

132 Non-DLT treatment-related adverse events occurring in more t

133 However, concomitant grade 1-2 non-DLT toxic effects (ie, gastrointestinal, fatigue, or cut

134 Non-DLTs included infusional reaction, rash, mucositis, prot

135 , GI, and hepatic toxicities were common non-DLTs.

136 The most frequent non-DLTs included diarrhea, rash, and hyperbilirubinemia.

137 ary end points included determination of non-DLTs and preliminary radiographic and pathologic respons

138 Other non-DLTs included ataxia and headache.

139 virtue of the fact that it possesses a novel DLT-containing KEAP1-interaction motif.

140 because of the relatively constant observed DLT rate at the lower four dose levels, the recommended

141 bility criteria, dose levels, definitions of DLT and MTD, and pharmacokinetic sampling times were des

142 No episodes of DLT were observed at gemcitabine and capecitabine doses

143 /m(2), the estimated cumulative incidence of DLT was > 50%, and the estimated cumulative incidence of

144 60 to 100 mg/m(2) without the occurrence of DLT.

145 Two occurrences of DLT were observed.

146 The estimated probability of DLT for dose level 3 was .21 (90% posterior probability

147 as the SBRT dose at which the probability of DLT was closest to 20% without exceeding it.

148 was assessed as a function of the number of DLTs observed.

149 for the 3 + 3 design, whereas the number of DLTs per study was the same (average +/- SD, 3.3 +/- 1.1

150 One DLT of grade 3 elevation in ALT was seen.

151 At dose level 3 of 1000 mg/m(2), one DLT was encountered and three more patients were enrolle

152 he *28/*28 genotype, the MTD was 400 mg (one DLT per six patients), and 500 mg was not tolerated (thr

153 uncomplicated febrile neutropenia (the only DLT) in one patient, reversible elevations in hepatic tr

154 Other DLTs included diarrhea and fatigue; grade 3 thrombocytop

155 There were no other DLTs.

156 The primary DLT in both studies was diarrhea.

157 The primary DLTs were neutropenia and rash.

158 cute and late mucosal and pharyngeal-related DLT required de-escalation of gemcitabine dose in succes

159 T), with at least two of three or two of six DLT at next higher dose.

160 g/m(2), respectively, met protocol-specified DLT criteria; however, at these doses 65% of successive

161 Ten DLTs occurred in nine patients, including grade 4 platel

162 The DLT of this DX-8951f schedule was granulocytopenia for m

163 The DLT was fatigue; 50 mg/d was the MTD.

164 The DLT was grade 3 pharyngolaryngeal dysesthesia, sensory n

165 The DLT was reversible hepatotoxicity and skin rash at 70 mg

166 The DLT was reversible hepatotoxicity at 55 mg/m(2).

167 The DLT was systemic, manifested as an elevation in liver fu

168 The DLT, MTD, PK, and adverse effect profile of oxaliplatin

169 sion; and 40 mg/m(2) for acute leukemia, the DLT being hepatotoxicity.

170 ith 3F8 10 mg/m(2)/d in prior protocols, the DLT of pain was defined as more than seven doses of opio

171 for 5 days: 2 mg/m(2) for solid tumors, the DLT being myelosuppression; and 40 mg/m(2) for acute leu

172 Prolonged neutropenia was the DLT at 420 mg/m(2) in heavily pretreated patients.

173 Grade 3, reversible ototoxicity was the DLT in less-heavily pretreated patients at 420 mg/m(2).

174 Myelosuppression was the DLT.

175 The DLTs observed were one thrombosis (120 mg/m2), one grade

176 The DLTs were mainly myelosuppression and diarrhea.

177 The DLTs were thrombocytopenia and neutropenia.

178 The DLTs with both schedules were gastrointestinal.

179 rded as treatment related (epistaxis and the DLTs of diarrhoea and hyperglycaemia).

180 Stomatitis and hand-foot syndrome were the DLTs.

181 ted patients were to be enrolled until their DLTs were encountered, and MTDs defined.

182 In light of these DLTs and other toxicities noted at 120 mg, the dose of 8

183 In the expansion cohort at the MTD, three DLT's were encountered.

184 Three DLTs were reported: grade 3 lipase increase (n = 2; 100

185 tients), and 500 mg was not tolerated (three DLTs per three patients).

186 Of those, 114 were submitted to DLT.

187 nd to describe the dose-limiting toxicities (DLT) and safety profile of this combination.

188 dose (MTD) and the dose-limiting toxicities (DLT) of 17-allylamino-17-demethoxygeldanamycin (17-AAG)

189 erated dose (MTD), dose-limiting toxicities (DLT), and pharmacokinetics of vorinostat administered as

190 ermine the safety, dose-limiting toxicities (DLT), maximum-tolerated dose (MTD), and pharmacokinetics

191 nd to describe the dose-limiting toxicities (DLTs) and pharmacokinetics of lonafarnib.

192 (MTD) and describe dose-limiting toxicities (DLTs) and the incidence and severity of other toxicities

193 The dose-limiting toxicities (DLTs) encountered were grade 3 diarrhea in three patient

194 Dose-limiting toxicities (DLTs) in the MONO study were fever, hypotension, acute l

195 Dose-limiting toxicities (DLTs) included perforated ulcer in one patient in the 50

196 d doses (MTDs) and dose-limiting toxicities (DLTs) of clofarabine, given as a 1-hour infusion daily f

197 e 60 mg/m(2), with dose-limiting toxicities (DLTs) of fatigue, nausea, vomiting, and diarrhea observe

198 cted to define the dose-limiting toxicities (DLTs) of its combination with cytarabine (ara-C), idarub

199 Dose-limiting toxicities (DLTs) were assessed during cycle 1 of each cohort, and c

200 Dose-limiting toxicities (DLTs) were assessed during the first cycle to determine

201 ng a 3 + 3 design, dose-limiting toxicities (DLTs) were assessed weekly during cycle 1.

202 Dose-limiting toxicities (DLTs) were defined as treatment related, occurring durin

203 Dose-limiting toxicities (DLTs) were evaluated during the first 6 weeks of therapy

204 Dose-limiting toxicities (DLTs) were grade 3 hypersensitivity reaction (n = 1) and

205 No dose-limiting toxicities (DLTs) were observed at the 50, 65, and 85 mg/m(2) dose l

206 No dose-limiting toxicities (DLTs) were observed in patients treated in cohort I at e

207 erated dose (MTD), dose-limiting toxicities (DLTs), and pharmacokinetic and pharmacodynamic propertie

208 erated dose (MTD), dose-limiting toxicities (DLTs), and pharmacokinetic properties of pemetrexed in c

209 ose (MTD), safety, dose-limiting toxicities (DLTs), and pharmacokinetics (PK) of APR-246.

210 y to determine the dose-limiting toxicities (DLTs), characterize the pharmacokinetic profile, and doc

211 d to determine the dose-limiting toxicities (DLTs), maximum tolerated dose, pharmacokinetic profile,

212 Safety, dose-limiting toxicities (DLTs), maximum-tolerated dose (MTD), and preliminary ant

213 Dose-limiting toxicities (DLTs), MTD, and pharmacokinetics were determined for eac

214 rash, the primary dose-limiting toxicities (DLTs), occurred at 800 mg.

215 nd determining the dose-limiting toxicities (DLTs), pharmacokinetics, and biologic effects of BV in c

216 toxicity profile, dose-limiting toxicities (DLTs), pharmacokinetics, and preliminary response rate f

217 tolerated without dose-limiting toxicities (DLTs).

218 ion and/or rash as dose-limiting toxicities (DLTs).

219 patients developed dose-limiting toxicities (DLTs): grade (G) 2 nausea at 120 mg; G3 fatigue at 250 m

220 Two dose-limiting toxicities (DLTs; grade 3 arthralgia and grade 3 fatigue) were repor

221 n the incidence of dose-limiting toxicities (DLTs; primary endpoint): 400 mg of spartalizumab every 4

222 ded determination of dose-limiting toxicity (DLT) and a phase II dose; secondary end points included

223 les to determine the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD), as well as to pro

224 mary end points were dose-limiting toxicity (DLT) and MTD.

225 Dose-limiting toxicity (DLT) assessment occurred during cycle 1.

226 e levels and was the dose-limiting toxicity (DLT) at 100 mg/m2/d of TMZ combined with 120 mg/m2/d O6B

227 Dose-limiting toxicity (DLT) consisted of elevation of both total and direct bil

228 Dose-limiting toxicity (DLT) consisted of worsening neuropathy at 1.34 mg/kg.

229 of four patients had dose-limiting toxicity (DLT) consisting of rash and hyperbilirubinemia, whereas

230 , design parameters, dose-limiting toxicity (DLT) definition, DLT rate, patient-dose allocation, over

231 reases were based on dose-limiting toxicity (DLT) encountered in cohorts of three consecutive patient

232 lead-in module, one dose-limiting toxicity (DLT) event was observed, while two (7%) of 28 had PSA de

233 sis syndrome was the dose-limiting toxicity (DLT) for CLL, the maximum-tolerated dose (MTD) was 75 mg

234 1 mg/kg experienced dose-limiting toxicity (DLT) from immune-related adverse events (irAEs).

235 at was given without dose-limiting toxicity (DLT) from part 1 was administered continuously beginning

236 and those who had a dose-limiting toxicity (DLT) in cycle 1 irrespective of dose modification.

237 ermined based on the dose-limiting toxicity (DLT) in the first cycle.

238 primary endpoint was dose-limiting toxicity (DLT) in the first treatment cycle (21 days).

239 Dose limiting toxicity (DLT) is grade 4 thrombocytopenia (n = 2).

240 Dose-limiting toxicity (DLT) occurred in two of three patients treated at 33 mg/

241 atient cohorts until dose-limiting toxicity (DLT) occurred.

242 rated dose (MTD) and dose-limiting toxicity (DLT) of bevacizumab, when added to the standard FHX (flu

243 rated dose (MTD) and dose limiting toxicity (DLT) of irinotecan administered in combination with vinc

244 rated dose (MTD) and dose-limiting toxicity (DLT) of irinotecan in patients with advanced solid tumor

245 daily The principal dose-limiting toxicity (DLT) of tandutinib was reversible generalized muscular w

246 defined criteria for dose-limiting toxicity (DLT) or temporarily holding therapy with PEG-IFN-lambda.

247 doses with a 4-week dose-limiting toxicity (DLT) period.

248 Dose-limiting toxicity (DLT) seen in both cohorts at the starting dose required

249 evel associated with dose-limiting toxicity (DLT) through cycle 2 in < or = 20% of patients.

250 Treatment-related dose-limiting toxicity (DLT) was defined as any grade 3 or 4 nonhematologic toxi

251 Dose-limiting toxicity (DLT) was defined as any nonhematologic, treatment-relate

252 Dose-limiting toxicity (DLT) was defined as any treatment-related grade 3 or wor

253 Dose-limiting toxicity (DLT) was defined as febrile neutropenia, prolonged neutr

254 Dose-limiting toxicity (DLT) was defined as grade 3 or worse GI/genitourinary (G

255 escalation until the dose-limiting toxicity (DLT) was defined.

256 30% to 35% until the dose-limiting toxicity (DLT) was defined.

257 No dose-limiting toxicity (DLT) was encountered on dose levels 1 and 2.

258 y 2 weeks' schedule, dose-limiting toxicity (DLT) was evident at the 1.75 and 1.9 mg/m2 dose levels,

259 Dose-limiting toxicity (DLT) was failure to reconstitute neutrophils to greater

260 Dose-limiting toxicity (DLT) was neurologic in both children and adults.

261 Dose-limiting toxicity (DLT) was observed at the third and fourth cohort (1 pati

262 aluable patients, no dose-limiting toxicity (DLT) was observed in patients treated at any dose level

263 No dose-limiting toxicity (DLT) was observed in the nine assessable patients who re

264 ued until consistent dose-limiting toxicity (DLT) was observed.

265 or until consistent dose-limiting toxicity (DLT) was observed.

266 Dose limiting toxicity (DLT) was seen at 20 mCi/m(2), with two patients experien

267 se elevation was the dose-limiting toxicity (DLT), and dose level 2 was the maximum tolerated dose (M

268 number experiencing dose-limiting toxicity (DLT), and the number still at risk of developing a DLT.

269 primary endpoint was dose-limiting toxicity (DLT), assessed during the first treatment cycle (21 days

270 ug-related (93%) and dose-limiting toxicity (DLT), constituting four of 10 DLTs.

271 Dose-limiting toxicity (DLT), grade 4 neutropenia, occurred at 188 mg/m(2)/d x 5

272 in six patients had dose limiting toxicity (DLT), including veno-occlusive disease (VOD).

273 Dose-limiting toxicity (DLT), maximum-tolerated dose (MTD), pharmacokinetics, im

274 olerated dose (MTD), dose-limiting toxicity (DLT), pharmacokinetics (PK), and adverse effect profile

275 olerated dose (MTD), dose-limiting toxicity (DLT), safety, pharmacokinetics, and pharmacodynamics of

276 of six patients with dose-limiting toxicity (DLT), with at least two of three or two of six DLT at ne

277 /d in the absence of dose-limiting toxicity (DLT).

278 rated dose (MTD) and dose-limiting toxicity (DLT).

279 study end point was dose-limiting toxicity (DLT).

280 s were evaluable for dose-limiting toxicity (DLT).

281 tcome was safety and dose-limiting toxicity (DLT).

282 ing donor (LD) domino liver transplantation (DLT) in maple syrup urine disease (MSUD) are limited.

283 the use of a double-lumen endotracheal tube (DLT); a few centers use carbon dioxide (CO2) insufflatio

284 rs ago, confirmation of a double-lumen tube (DLT) position was limited to inspection and auscultation

285 00 mg (15 evaluable patients experienced two DLTs).

286 tients), and 1,000 mg was not tolerated (two DLTs per six patients).

287 Only patients undergoing DLT presented with piggy-back syndrome (7% vs 0%, P = 0.

288 ined, the dose of ZD9331 was increased until DLT occurred.

289 the more strict sequences consisting of (I/V)DLT that have a preference in high affinity SUMO2 and -3

290 d and tolerable at doses <or= 600 mg/d, were DLTs at 800 mg/d (maximum-tolerated dose).

291 , febrile neutropenia, and paresthesias were DLTs.

292 e curve for FU correlated significantly with DLT (P = .006) and grade 3 to 4 diarrhea (P = .004).

293 ZD1839 was well tolerated, with DLT observed at a dose well above that at which antitumo

294 0 mg once a day but none was tolerable, with DLTs of thrombocytopenia, gastrointestinal events (diarr

295 calation to 50 Gy has been completed without DLT.

296 evaluable for toxicity at 666 MBq/kg without DLT.

297 valuable at 444, 555, and 666 MBq/kg without DLT.

298 rmitted dose escalation to 160 mg/m2 without DLT.

299 Patients without DLT and no evidence of disease progression after 48 week

300 , and then six were treated at DL-2, without DLTs.