[c09aa8]: / clusters / clustall9k / 311.txt

Download this file

335 lines (334 with data), 45.3 kB

  1
  2
  3
  4
  5
  6
  7
  8
  9
 10
 11
 12
 13
 14
 15
 16
 17
 18
 19
 20
 21
 22
 23
 24
 25
 26
 27
 28
 29
 30
 31
 32
 33
 34
 35
 36
 37
 38
 39
 40
 41
 42
 43
 44
 45
 46
 47
 48
 49
 50
 51
 52
 53
 54
 55
 56
 57
 58
 59
 60
 61
 62
 63
 64
 65
 66
 67
 68
 69
 70
 71
 72
 73
 74
 75
 76
 77
 78
 79
 80
 81
 82
 83
 84
 85
 86
 87
 88
 89
 90
 91
 92
 93
 94
 95
 96
 97
 98
 99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
309
310
311
312
313
314
315
316
317
318
319
320
321
322
323
324
325
326
327
328
329
330
331
332
333
334
Ongoing serious, non-healing wound, ulcer, or bone fracture
History of serious or non-healing wound, ulcer, or bone fracture
Serious or non-healing wound, skin ulcer, or bone fracture
Prior osteoporotic fracture
Serious nonhealing wound, ulcer, or bone fracture
Serious non-healing wound, ulcer, or bone fracture within 6 months prior to enrollment
Serious, non-healing wound, active ulcer, or untreated bone fracture
Serious, non-healing wound, ulcer, or bone fracture.
Serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to initiation of study treatment;
Patients with serious or non-healing wound, ulcer, or bone fracture
Patients with a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment
Serious or non-healing wound, ulcer, or bone fracture.
Presence of a non-healing wound, or non-healing ulcer, (that is not tumor related) or bone fracture
Any patient with a current non-healing wound, bone fracture, or skin ulcer is excluded
Presence of serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment
Serious, non-healing wound; active ulcer; or untreated bone fracture
Presence of any non-healing wound, fracture, or ulcer within 28 days prior to study registration.
Patients with serious or non-healing wound, ulcer, or bone fracture.
Patients who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrollment are not eligible
Ongoing serious, non-healing wound, ulcer, or bone fracture.
Patients with a serious non-healing wound, active ulcer, or untreated bone fracture
Presence of non-healing wound, non-healing ulcer, or bone fracture
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Any severe or poorly controlled systemic disease (e.g., hypertension; clinically significant cardiovascular, pulmonary, or metabolic disease, disorders of wound healing, ulcer or bone fracture)
Serious, non-healing wound, ulcer, or bone fracture
Serious, non-healing wound or ulcer; bone fracture within 3 months prior to study entry
Serious or non-healing wound, ulcer or bone fracture
History or evidence of arterial thrombotic or hemorrhagic disorders within 3 months before proposed start of treatment, non-healing wound, ulcer, or bone fracture
Patients who have a non-healing wound, ulcer, or bone fracture.
Serious non-healing wound, ulcer or bone fracture
Serious, non-healing wound, active ulcer, or untreated bone fracture.
Non-healing wound, ulcer, non-healing traumatic bone fracture, or abscess within 30 days of enrollment\r\n* Nondisplaced, uncomplicated pathologic fracture due to tumor may be eligible provided adequately treated with radiation, surgery or other treatments with full recovery based upon investigator assessment
Has a known history of non-healing wounds or ulcers, or bone re-fractures within 3 months of fracture
Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
Serious, non-healing wound, ulcer, or bone fracture
Serious, non-healing wound, ulcer, or bone fracture.
Serious non-healing wound, ulcer or bone fracture
Non-healing wound, ulcer, or bone fracture
Patients who have serious, non-healing wound, ulcer, or bone fracture
Serious, non-healing wound, ulcer, or bone fracture.
have any non-healing wound, fracture, or ulcer within 28 days prior to the planned start of study treatment;
(Bevacizumab-related exclusion) History of abdominal fistula or gastrointestinal perforation within 6 months prior to the first study treatment. Serious, non-healing wound, active ulcer, or untreated bone fracture (adjuvant trials: bone fractures must be healed)
Serious non-healing or dehiscing wound, active ulcer, or untreated or non-healing bone fracture
FOR ALL PHASES (Ib AND II): Non-healing wound or ulcer
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Serious or non-healing wound, ulcer, or bone fracture.
Serious, non-healing wound, active ulcer, or untreated bone fracture, including tumor-related pathological fracture
Presence of a non-healing wound, non-healing ulcer or bone fracture
History of abdominal fistula or gastrointestinal perforation =< 6 months before cycle 1, day 1; serious non-healing wound, active ulcer, or untreated bone fracture (adjuvant trials: bone fractures must be healed)
Non-healing wound, ulcer, or bone fracture
Serious, non-healing or dehiscing wound or active ulcer
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Participant has a serious, non-healing wound, ulcer, or bone fracture
Active wound, a serious or non-healing wound, an active ulcer or untreated bone fracture
Non-healing wound, bone fracture, or skin ulcer
mCRPC EXPANSION COHORT: Other clinically significant disorders such as:\r\n* Active infection requiring intravenous treatment within 7 days of starting protocol treatment\r\n* Serious non-healing wound/ulcer/bone fracture (excluding stable compression fracture) within 28 days before the first dose of study treatment
The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment
Non-healing wound, ulcer, or bone fracture
REGORAFENIB EXCLUSION CRITERIA: Presence of a non-healing wound, non-healing ulcer, or bone fracture
Non-healing wound, active peptic ulcer or bone fracture
The patient has a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment
Presence of a non-healing wound, non-healing ulcer, or benign bone fracture (patients with stress insufficiency fractures e.g. from osteoporosis or pathological fracture from tumor are eligible for study)
Serious or nonhealing wound, ulcer, bone fracture, or osteonecrosis of the jaw
Subject has a serious, non-healing wound, ulcer, or bone fracture
Presence of any non-healing wound, fracture, or ulcer
Patients who have serious, non-healing wound, ulcer, or bone fracture
Serious, non-healing wound, active ulcer, or untreated bone fracture
Serious non-healing wound, ulcer, or bone fracture
Serious, non-healing wound, ulcer, or bone fracture
Serious non-healing wound, active peptic ulcer, or untreated bone fracture
Serious non-healing wound, non-healing ulcer, or bone fracture
Serious or non-healing wound, ulcer or bone fracture
The patient has a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy
Serious, non-healing wound, active ulcer, or untreated bone fracture
A serious, non healing wound, ulcer, or bone fracture
Serious, non-healing wound, active ulcer, or untreated bone fracture; any bone fractures must be healed
Serious, non-healing wound, ulcer, or bone fracture
Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
Non healing wound, ulcer or bone fracture
Non-healing serious wound, ulcer, or bone fracture unrelated to the primary tumor
Non?healing wound, ulcer, or bone fracture
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Presence of a serious nonhealing wound, ulcer, or bone fracture
Ongoing significant, uncontrolled medical condition including: o Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.
History of serious or non-healing wound, ulcer, or bone fracture
Patients with a non-healing wound, fracture, or ulcer
Non-healing wound, ulcer or bone fracture
Patients with serious non-healing wound, ulcer, or bone fracture within 28 days before registration; patients should not have had any major surgical procedures within 28 days of registration
Serious, non-healing wound, active ulcer, or untreated bone fracture
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Prior major surgery within the previous 28 days of study registration and/or presence of any non-healing wound, fracture, or ulcer
Subjects with a non-healing serious wound, ulcer, or bone fracture unrelated to the primary tumor
Patients who have a serious or non-healing wound, ulcer, or bone fracture at the time of study enrollment are not eligible
Serious or non-healing wound, ulcer or bone fracture
Serious non-healing wound, ulcer, bone fracture, or abscess
Serious, non-healing wound, ulcer, or bone fracture
Patients with a serious or non-healing wound, ulcer, or bone fracture are not eligible for this study
Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
Serious, non-healing wound, ulcer, or bone fracture
Presence of a non-healing wound, non-healing ulcer, or bone fracture
The participant has a serious nonhealing: (a) wound, (b) peptic ulcer, or (c) bone fracture.
Serious, non-healing wound, infection, ulcer, bone fracture, or uncontrolled seizures
Patients with a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment
Patient must not have serious or non-healing wound, ulcer, or bone fracture at the time of randomization
Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease
Patients are excluded if they have a non-healing wound or ulcer
Presence of non-healing wound, non-healing ulcer, or bone fracture.
Have had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment.
Serious non-healing wound, ulcer or bone fracture
Patients with serous non-healing wound, ulcer, or bone fracture.
Serious, non-healing wound, ulcer, or bone fracture requiring surgical intervention.
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Serious non-healing wound, ulcer, or bone fracture
Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
Non-healing wound, ulcer or bone fracture
Presence of a non-healing wound, non-healing ulcer, or bone fracture.
Has history of a non-healing wound, ulcer, or bone fracture within 90 days (3 months) prior to entry in to the trial
Serious non-healing wound, ulcer, or bone fracture
Serious, non-healing wound, active ulcer, or untreated bone fracture as judged by treating physician
Serious, non-healing wound, ulcer, or bone fracture
Patients with a history of a serious non-healing wound, ulcer, or bone fracture are not eligible
Serious, non-healing wound, ulcer, or bone fracture
Serious or non-healing wound, active ulcer or bone fracture
Non-healing wound, ulcer or bone fracture
Serious, non-healing wound, ulcer, or bone fracture as so judged by the treating physician
Presence of a non-healing wound or non-healing ulcer that is not tumor related
Presence of any non-healing wound, fracture, or ulcer within 28 days prior to the first dose of study drug.
Other clinically significant disorders such as:\r\n* Active infection requiring systemic treatment within 28 days before the first dose of study treatment\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Non-healing wound, ulcer, or bone fracture
Presence of any non-healing wound, fracture, or ulcer within 28 days prior to study registration.
Has a history of non-healing wounds or ulcers, or bone refractures within 3 months of fracture
Patients with serious non-healing wound, ulcer, or bone fracture
Serious or non-healing wound, ulcer, or bone fracture
Non-healing wound, ulcer, or bone fracture
Patients with serious non-healing wound, ulcer, or bone fracture, including history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Presence of a non-healing wound or non-healing ulcer that is not tumor related
Serious non-healing wound, ulcer, or bone fracture
Ongoing serious, non-healing wound, ulcer, or bone fracture
Ongoing serious, non-healing wound, ulcer, or bone fracture
Serious or non-healing wound, skin ulcer, or bone fracture.
Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
Participants who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrollment
Serious non-healing wound, ulcer, or bone fracture
Serious non-healing wound, ulcer, or bone fracture
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Patients with a serious, non-healing wound, ulcer, or bone fracture are not eligible for participation
Non-healing wound, bone fracture or skin ulcer
Presence of a non-healing wound, non-healing ulcer, or bone fracture
No history of serious (i.e., requiring active medical therapy with medication or medical device under the supervision of a physician) non-healing wound, ulcer, trauma, or bone fracture within 28 days prior to study entry
Non-healing wound, ulcer or fracture
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Serious or non-healing wound, ulcer or bone fracture
History of a non-healing wound, ulcer, or bone fracture within 90 days (3 months) prior to registration
Non-healing wound, ulcer (including gastrointestinal), or fracture
Serious or non-healing wound, ulcer or bone fracture; if patient develops a serious or non-healing wound, ulcer or bone fracture after enrollment, but prior to study drug initiation, patient is not eligible to begin protocol therapy
Non-healing wound, ulcer or bone fracture
No serious non-healing wound, ulcer or bone fracture
Serious, non-healing wound, active ulcer, or untreated bone fracture
Serious or non-healing wound, ulcer, or bone fracture
Serious, non-healing wound, active ulcer, or untreated bone fracture
History of serious or non-healing wound, ulcer, or bone fracture
Serious, non-healing wound, active ulcer, or untreated bone fracture
Patients with a history of non-healing wounds or ulcers, or bone refractures within 3 months of fracture
Non-healing wound, ulcer, or bone fracture
Patients with documented chronic non-healing wound, ulcer or bone fracture
Subject has a serious, non-healing wound, ulcer, or bone fracture
Serious or non-healing active wound, ulcer, or bone fracture
Serious non-healing wound, active ulcer, or unhealed bone fracture.
Patients with serious non-healing wound, ulcer, or untreated bone fracture. This includes a history of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1. Patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations until closure.
Serious or non-healing wound, ulcer or bone fracture
Serious, non-healing wound, ulcer, or bone fracture
Serious, non-healing wound, ulcer, or bone fracture
Non-healing wound, ulcer, or bone fracture.
Serious non-healing wound or ulcer on scalp
Severe acute infection; serious non-healing wound or ulcer on scalp
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Presence of a non-healing wound, non-healing skin ulcer, or bone fracture
Presence of a non-healing wound or bone fracture
Serious, non-healing wound, active ulcer, or untreated bone fracture
Patients with a serious non-healing wound ulcer, or bone fracture, or major surgical procedure within 21 days prior to starting treatment
Non-healing wound, ulcer, or bone fracture.
Have a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to receiving study drugs.
Serious, non-healing wound, ulcer, or bone fracture.
Uncontrolled diabetes, active liver disease, poorly controlled chronic obstructive pulmonary disease, serious or non-healing wound, ulcer, or fracture;
Serious, non-healing wound, ulcer, or bone fracture
Severe, nonhealing or open wound, active ulcer, or untreated bone fracture
Serious and non-healing wound, active ulcer, or untreated bone fracture.
Non-healing wound, ulcer, or bone fracture
Patients must not have a non-healing wound or fracture
Presence of any non-healing wound, fracture, or ulcer
Non-healing wound, skin ulcer, or bone fracture
Serious or non-healing wound, active ulcer, or untreated bone fracture
Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Serious, non-healing wound, ulcer, or bone fracture
Serious or non-healing active wound, ulcer, or bone fracture
Ongoing serious non-healing wound, ulcer, or bone fracture
Non-healing wound, ulcer (including gastrointestinal), or fracture
Serious, non-healing wound, active ulcer, or untreated bone fracture; bone fractures must be healed
Serious non-healing wound, ulcer, or bone fracture
Serious non-healing wound, ulcer, or active bone fracture;
Serious or non-healing wound, ulcer, or bone fracture
Has had a serious nonhealing wound, ulcer, or bone fracture within 4 weeks prior to randomization
Serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
Patients with serious non-healing wound, ulcer or bone fracture; this includes history of abdominal fistula or intra-abdominal abscess within 6 months; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
Serious non-healing wound, ulcer, or bone fracture
A serious, non-healing wound, ulcer, or bone fracture
Serious, non-healed wound, ulcer, or bone fracture
No history of serious non-healing wound, ulcer, or bone fractures
Serious, non-healing or dehiscing wound or active ulcer
Any serious or non-healing wound, ulcer, or bone fracture
Serious, non-healing wound, active ulcer, or unhealed bone fracture
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
Patients with serious, non-healing wound, ulcer or bone fracture (other than pathologic fracture)
Serious, non-healing or dehiscing wound or active ulcer
History of recent fracture (within 3 months of recruitment), complicated non-healing fracture, hip arthroplasty, knee arthroplasty
Patient must not have a serious or non-healing wound, ulcer, or bone fracture
Patients must have sufficient resolution of any surgical side effects (no active wound healing complications). -Patients must either be initiating or have already started adjuvant hormonal treatment. -
Patients who have undergone major surgery or trauma within 28 days prior to the first dose of investigational product and/or present with any non-healing wound, fracture, or ulcer are NOT eligible for participation; procedures such as catheter placement not considered to be major surgery
Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery)
Participants must meet the following windows from procedures (there is no window required for port placement since there is no anticipated impact on wound healing with bavituximab):\r\n* Major surgery (ex. craniotomy) within 3 weeks of initiation of treatment\r\n* Brain biopsy within 2 weeks
Prior major surgery or fracture within 3 weeks prior to randomization or presence of any non-healing wound.
Patient has had major surgery or insufficient recovery from surgical-related trauma or wound healing within 14 days of study day 1
Insufficient recovery from surgical-related trauma or wound healing
Major surgery within 12 weeks before the first dose of cabozantinib; complete wound healing from major surgery must have occurred 1 month before the first dose of cabozantinib; minor surgery (including uncomplicated tooth extractions) is allowed if it occurred 28 days before the first dose of cabozantinib with complete wound healing at least 10 days before the first dose of cabozantinib; subjects with clinically relevant ongoing complications from prior surgery are not eligible
Patients with serious non-healing wound, ulcer, or bone factor; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
Major surgery within 12 weeks before the first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment. Minor surgery (including uncomplicated tooth extractions) within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
Other clinically significant disorders such as:\r\n* Active infection requiring systemic treatment within 28 days before the first dose of study treatment; participants with HIV infection will be eligible provided they meet the criteria; participants with known hepatitis B infection should be screened for active disease prior to study participation; participants with known hepatitis C infection must not be actively receiving treatment for the infection\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment\r\n* History of major surgery as follows:\r\n** Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications\r\n** Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications\r\n* In addition, complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery
Have active poor wound healing (delayed healing, wound infection or fistula)
Patients who have had major surgery or have insufficient recovery from surgical-related trauma or wound healing within 14 days from study day 1
Patients who are less than 4 weeks from surgery (except biopsies) or have insufficient recovery from surgical-related trauma or wound healing
Any open wound
Subject who has an active or potential infection at the surgical site, or whose surgical wound is defined as a wound classification of CO (Contaminated) or D (Dirty or Infected) based upon the Center for Disease Control and Prevention's wound classification system; and
Insufficient recovery from surgical-related trauma or wound healing
Other clinically significant disorders such as: i. active infection requiring systemic antibiotic treatment within 14 days before the first dose of study treatment ii. serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment iii. history of organ transplant iv. concurrent uncompensated hypothyroidism or thyroid dysfunction (thyroid-stimulating hormone [TSH] above 10) within 28 days before the first dose of study treatment v. major surgery within 12 weeks before the first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment. Minor surgery within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
Major surgery within 12 weeks before the first dose of study treatment; complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment; minor surgery (including uncomplicated tooth extractions) within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment; all clinically relevant ongoing complications from prior surgery should be resolved before the first dose of study treatment
Subjects who are less than 21 days from surgery or have insufficient recovery from surgical-related trauma or wound healing.
Major surgery within 12 weeks before the first dose of study treatment; complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment; minor surgery (including uncomplicated tooth extractions) within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment; subjects with clinically relevant ongoing complications from prior surgery are not eligible
Patients who are less than 4 weeks from surgery or have insufficient recovery from surgical-related trauma or wound healing
At least 4 weeks must have elapsed since any surgeries, with evidence of good wound healing
Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement are not considered to be major surgery)
Patient has had major surgery or insufficient recovery from surgical-related trauma or wound healing within 14 days of study day 1
Evidence of wound dehiscence
History of major surgery as follows:\r\n* Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications\r\n* Minor surgery within 1 months of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications
In addition, complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery
Other clinically significant disorders such as:\r\n* Active infection requiring systemic treatment within 28 days before the first dose of study treatment\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment\r\n* History of major surgery as follows:\r\n** Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications\r\n** Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications\r\n* In addition, complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery
Major surgery within 12 weeks before the first dose of study treatment; complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment; minor surgery (including uncomplicated tooth extractions) within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment; subjects with clinically relevant ongoing complications from prior surgery are not eligible
At least 4 weeks must have elapsed since any surgeries, with evidence of completed wound healing
Previous surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of registration, and that wound healing has occurred
No evidence of a history of wound healing complications prior to study enrollment
Increased risk of wound dehiscence or presence of non-healing wounds
Serious, non-healing or dehiscing wound
Signs of wound-healing problems or infection at the craniotomy/biopsy site.
Subject has had at least 4 weeks of postoperative recovery from surgery prior to enrollment to ensure complete wound healing
Patients who are less than 4 weeks from CRS/HIPEC or have insufficient recovery from surgical-related trauma or wound healing as determined by the patient’s surgeon
Must not exhibit a non-healing wound or any skin breakdown
Major surgery or trauma within 28 days prior to first dose of pazopanib and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery)
Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major)
Major surgery within 12 weeks before the first dose of study treatment; complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment; minor surgery (including uncomplicated tooth extractions) within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment; subjects with clinically relevant ongoing complications from prior surgery are not eligible
Other clinically significant disorders such as:\r\n* Active uncontrolled infection requiring intravenous systemic treatment within 14 days before the first dose of study treatment\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment\r\n* History of major surgery as follows:\r\n** Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications\r\n** Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications\r\n*** In addition, complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery
Evidence of inadequate wound healing
Other clinically significant disorders such as:\r\n* Active infection requiring systemic treatment\r\n* Serious non-healing wound/ulcer/bone fracture\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction\r\n* History of major surgery within 4 weeks or minor surgical procedures within 1 week before randomization
Major surgery or trauma within 28 days prior to first dose of pazopanib and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery)
Have had major surgery within 7 days prior to initiation of study drug to allow for postoperative healing of the surgical wound and site(s).
Has evidence of inadequate wound healing.
Subject with an unhealed surgical wound or other clinically significant wound
Subjects who have undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: \r\n* Prior to initiating therapy, 4 weeks must have elapsed since surgery; \r\n* Subjects must have recovered from surgical-related trauma; \r\n* Wound healing needs to have occurred
Unhealed surgical wound at time of treatment, or history of unhealed surgical wound for more than 30 days
Insufficient recovery from surgical-related trauma or wound healing
Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s).
Subjects who have an active clinically serious infection of CTCAE Grade ?2 or non-healing wound unrelated to the primary Tumor.
Patient has an unhealed surgical wound
Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s)
If most recent therapy was surgery, participants must be at least 30 days out from definitive surgery with no active wound healing complications
History of major/minor surgery as follows:\r\n* Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications\r\n* Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications; in addition complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery
Surgery: >= 3 weeks from major surgery; if recent craniotomy, adequate wound healing must be determined by neurosurgical team
Major surgery or trauma within 28 days prior to first dose of study treatment and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery)
Prior major surgery or trauma within 28 days and/or presence of any non-healing wound, fracture or ulcer (procedures such as catheter placement not considered to be major)
Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery)
Patient must not have prior major surgery, trauma, presence of any non-healing wound, fracture, or ulcer within 28 days prior to first dose of study drug
Less than 4 weeks from surgery or insufficient recovery from surgical-related trauma or wound healing
Prior major surgery or trauma within 28 days prior to registration and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major); if the patient has a compression fracture secondary to tumor this should be treated and 28 days elapsed prior to entry on the protocol
Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major)
Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer not related to cancer (procedures such as catheter placement not considered to be major)
Other clinically significant disorders such as:\r\n* Active infection requiring systemic treatment\r\n* Serious non-healing wound/ulcer/bone fracture\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction\r\n* History of major surgery within 4 weeks or minor surgical procedures within 1 week before randomization
Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major)
Serious, non-healing wound
Prior major surgery or trauma within 28 days prior to first dose of pazopanib and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major)
Prior major surgery (defined as requiring general anesthesia) or trauma within 28 days prior to first dose of study drug, and/or not recovered from effects of that surgery, and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major), or patients that may require surgery during the course of the study
EXPANSION COHORT ONLY: Prior major surgery (defined as requiring general anesthesia) or trauma within 28 days prior to first dose of study drug, and/or not recovered from effects of that surgery, and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major), or patients that may require surgery during the course of the study
Serious, non-healing wound, ulcer, or bone fracture; patients with any wound requiring surgical intervention (including scalp wounds requiring cranioplasty) will be allowed to resume the study if the wound is clean and without further infection post-surgical intervention
Interval of at least 2 weeks from any prior neurosurgical resection (1 week for intracranial biopsy) to start of study drug; and patient must have adequate wound healing
Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major)
Prior major surgery or trauma within 28 days prior to the protocol-mandated 4-week drug holiday and/or presence of any non-healing wound, fracture, or ulcer.
Other clinically significant disorders such as:\r\n* Severe active infection requiring systemic treatment within 28 days before the first dose of study treatment\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment (for asymptomatic patients with an elevated thyroid stimulating hormone [TSH], thyroid replacement may be initiated if clinically indicated without delaying the start of study treatment)\r\n* History of major surgery as follows:\r\n** Major surgery within 3 months of the first dose of cabozantinib; however, if there were no wound healing complications, patients with rapidly growing aggressive cancers, may start as soon as 6 weeks if wound has completely healed post-surgery\r\n** Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications excluding core biopsies and Mediport placement\r\n* In addition, complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery
Subject has history of major surgery as follows:\r\n* Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications\r\n* Minor surgery within 1 months of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications\r\n* In addition complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery
History of major surgery as follows:\r\n* Major surgery within 3 months of the first dose of cabozantinib; major surgery within 6 months of the first dose of cabozantinib if there are complications related to wound healing\r\n* Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications (particularly when associated with delayed or incomplete healing) within 28 days; Note: complete healing following abdominal surgery must be confirmed prior to initiating treatment with cabozantinib even if surgery occurred more than 28 days ago
Any medical condition that requires intact wound healing capacity and is expected to endanger participant safety if wound healing capacity would be severely reduced during administration of the investigational agent
Impaired wound healing or other extremity complications due to diabetes mellitus in subjects whose Study Lesions are located in an extremity
Other clinically significant disorders such as:\r\n* Active infection requiring systemic treatment within 28 days before the first dose of study treatment\r\n* Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\r\n* History of organ transplant\r\n* Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment\r\n* Major surgery (eg, thoracotomy, removal or biopsy of brain metastasis) within 3 months before week 1 day 1; complete wound healing from major surgery must have occurred 1 month before week 1 day 1 and from minor surgery (eg, simple excision, tooth extraction) at least 10 days before week 1 day 1; subjects with clinically relevant ongoing complications from prior surgery are not eligible
Prior major surgery or trauma within 28 days prior to the first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
Prior major surgery or trauma within 14 days of the first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer
Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
Major surgery or trauma within 29 days prior to first dose of study drug and/or presence of any non-healing wound, fracture or ulcer (catheter placement is not major surgery)
Patients who have not recovered from the surgical resection of rectal cancer such as wound dehiscence, non-healing wound, wound infection and fistula
Patient must not have prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major)
Incomplete recovery from any surgery
Incomplete recovery from major surgery within 4 weeks of enrollment
Major injuries and/or surgery within the past 4 weeks prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
Incomplete recovery from acute effects of any surgery prior to treatment.
Major injuries and/or surgery within the past 4 weeks prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
Any sign of active uncontrolled disease including but not restricted to cardiac disease, infections, hepatitis; any severe chronic disease potentially interfering with the protocol including human immunodeficiency virus (HIV) infection, active hepatitis B or C; it includes major injuries and/or surgery within the past 4 weeks prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
ENTRECTINIB EXCLUSION CRITERIA: Incomplete recovery from any surgery prior to treatment
Incomplete wound healing
Major injuries and/or surgery with then past 4 weeks prior to the start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
Patients who have had major injuries and/or surgery within the past 4 weeks (< 28 days) prior to registration with incomplete wound healing and/or planned surgery while the patient is on study treatment
Major injuries or surgery within the 4 weeks prior to initiation of therapy with incomplete wound healing or planned surgery during the on-study treatment period
Major injuries within the past 10 days prior to start of study treatment with incomplete wound healing
Major injuries and/or surgery within the past 4 weeks prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
No major injuries within the past 10 days prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
Incomplete healing from previous oncologic or other major surgery
Incomplete healing from previous oncologic or other major surgery
Major injuries within the past 10 days prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
Incomplete healing from previous oncologic treatments or other major surgery
Incomplete recovery or incomplete healing of wounds from previous surgery
GI surgery (particularly when associated with delayed or incomplete healing) within 28 days; Note: complete healing following abdominal surgery must be confirmed prior to initiating treatment with cabozantinib even if surgery occurred more than 28 days ago
Incomplete wound healing
Incomplete healing from previous surgery.
Incomplete healing from wounds from prior surgery
Incomplete recovery or incomplete healing of wounds from previous surgery, as determined by treating Investigator