[c09aa8]: / clusters / clustall9k / 360.txt

Download this file

181 lines (180 with data), 27.1 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
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of study drugs including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of study drugs including difficulty swallowing
Patients who have a known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing are not eligible
Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing.
Gastrointestinal (GI) condition that could interfere with the swallowing or absorption of defactinib.
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib or lenalidomide, including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing; patients with known GI involvement with mantle cell lymphoma who have no clinical evidence of active disease at the time of enrollment are eligible
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of study drugs, including difficulty swallowing tables
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of study drug, including difficulty swallowing. Gastroesophageal reflux under treatment with proton pump inhibitor or histamine H2 antagonist is allowed
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of study treatment including difficulty swallowing
Known gastrointestinal disease or gastrointestinal procedure that could interfere with the oral absorption or tolerance of study therapy, including difficulty swallowing.
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib, lenalidomide or dexamethasone including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of the study drugs including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib or lenalidomide including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of enzalutamide, including difficulty swallowing tablets
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing; patients who have had cystectomy with conduit, neobladder, or pouch using a portion of their terminal ileum are allowed if, the patient is stable without clinically significant metabolic disturbances OR stoma- and/or anastomosis-related complications OR post-surgical gut abnormalities that would compromise drug absorption
Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of study drugs, including difficulty swallowing tablets
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known gastro-intestinal disease or gastro-intestinal procedure that could interfere with the oral absorption or tolerance of MLN9708, including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659 including difficulty swallowing tablets; diarrhea > Grade 1 despite supportive therapy.
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib or idasanutlin including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib or ibrutinib, including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing
Patients must not have known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing oral medications per investigator’s clinical judgement
Known gastrointestinal (GI) disease or procedure that could interfere with the GI absorption or tolerance of bicalutamide, including difficulty swallowing oral medications.
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib (ixazomib citrate) including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 or pomalidomide including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of study drug
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption of study medication including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that is expected to interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing; as determined by the investigator
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 including difficulty
2. GI condition that could interfere with the swallowing or absorption of study drug.
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of fluconazole or itraconazole including difficulty swallowing capsules.
Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of orteronel, including difficulty or inability to swallow tablets
Known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption, or tolerance of IXAZOMIB
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659.
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659 including difficulty swallowing tablets or diarrhea >Grade 1 despite supportive therapy.
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Known gastrointestinal (GI) abnormality (including recurrent nausea or vomiting) or GI procedure that could interfere with or modify the oral absorption or tolerance of alisertib.
Known gastrointestinal (GI) disease or prior GI procedure that could interfere with the oral absorption or tolerance of the TAK-580.
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659, including difficulty swallowing tablets or diarrhea greater than (>) Grade 1 despite supportive therapy.
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659 including difficulty swallowing tablets; diarrhea >Grade 1 despite supportive therapy.
Patients must not have had any clinically-significant GI bleeding within 6 months prior to registration and patients must not have a GI disorder which (at the discretion of the investigator) bears a high risk of perforation or fistula; examples of this include (but are not limited to) Crohn’s disease or tumor with transmural extension through the gastrointestinal lining
Known gastrointestinal (GI) disease or GI procedures that could interfere with the oral absorption or tolerance of alisertib; examples include, but are not limited to partial gastrectomy, history of small intestine surgery, and celiac disease
Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the Investigator, may interfere with oral drug absorption
Unable to swallow tablets, patients with malabsorption syndrome, or any other GI disease or GI function that could interfere with absorption of study treatment
History of clinically significant GI bleed, intestinal obstruction, or GI perforation within 6 months of study dose
Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastro intestinal function or GI disease
Active gastrointestinal (GI) conditions and uncontrolled irritable bowel disease or pre-existing GI disorders that may interfere with proper absorption of the study drug
Has malabsorption due to prior gastrointestinal (GI) surgery or GI disease
GI condition that might limit absorption of oral agents
Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the investigator may interfere with oral drug absorption.
Presence of GI bleeding.
Current or recent (within 6 months) significant gastrointestinal (GI) disease or condition.
Presence of active gastrointestinal (GI) disease (including GI bleeding or ulceration) or other condition that could affect GI absorption (e.g. malabsorption syndrome, history of biliary tract disease), including refractory nausea or vomiting, or chronic GI disease which may affect absorption or tolerance to oral medications
Impairment of gastro intestinal (GI) function or GI disease.
Patients with inflammatory bowel disease and/or gastrointestinal (GI) ulcers and/or GI fistulas are eligible but only at the discretion of the study PI after personalized review of their medical history and proximity of SBRT targets to gastrointestinal mucosa
Current or recent (within 6 months) significant gastrointestinal (GI) disease or condition.
Patients who are unable to swallow tablets, patients with malabsorption syndrome, or any other gastrointestinal (GI) disease or GI dysfunction that could interfere with absorption of study treatment
Patients unable to swallow tablets, patients with malabsorption syndrome, or any other gastrointestinal (GI) disease or GI dysfunction that could interfere with absorption of study treatment
Major surgery to the upper GI tract, or have a history of GI disease or other medical condition that, in the opinion of the investigator may interfere with oral drug absorption
Active gastrointestinal (GI) ulceration or hemorrhage
No known gastrointestinal (GI) disease or GI procedures that could interfere with the oral absorption or tolerance of alisertib; examples include, but are not limited to partial gastrectomy, history of small intestine surgery, and celiac disease
History of gastrointestinal (GI) bleed requiring transfusion
Patients unable to swallow tablets, patients with malabsorption syndrome, or any other gastrointestinal (GI) disease or GI dysfunction that could interfere with absorption of study treatment
Gastrointestinal (GI) bleed within 30 days prior to registration on study
Active gastrointestinal (GI) hemorrhage within 2 weeks of study enrollment
Active gastrointestinal (GI) bleed within 2 weeks of study enrollment
Active GI ulcer disease within 4 weeks of study enrollment
GI hemorrhage or obstruction experienced within the previous 6 weeks
Current or recent (within 6 months) significant gastrointestinal (GI) disease or condition.
Patient must not have prior gastrointestinal (GI) surgery or GI disease that might interfere with the absorption of TRC102
Has a clinically significant gastrointestinal (GI) abnormality including:
Gastrointestinal (GI) condition that interferes with drug absorption
Patients who have known gastrointestinal (GI) disease or GI procedures which could interfere with the oral absorption or tolerance of alisertib are not eligible; examples include (but are not limited to) partial gastrectomy, history of small intestine surgery, and celiac disease
Known gastrointestinal (GI) disease or GI procedures that could interfere with the oral absorption or tolerance of alisertib; examples include, but are not limited to partial gastrectomy, history of small intestine surgery with significant removal of the small intestine, and celiac disease
Any gastrointestinal (GI) disorder or liver disease
History of diverticulitis, rectal bleeding or other lower gastrointestinal (GI) diseases predisposing to GI complications after radiation (will be determined by radiation oncologist)
Impairment of gastrointestinal (GI) function or GI disease or active ulceration of the upper gastrointestinal tract.
Gastrointestinal (GI) hemorrhage (active or in recent 6 months)
Known gastrointestinal (GI) disease or GI procedures that could interfere with the oral absorption or tolerance of alisertib; examples include, but are not limited to partial gastrectomy, history of small intestine surgery, and celiac disease
Presence of GI fistula
Presence of active gastrointestinal (GI) disease or other condition that could affect gastrointestinal absorption (e.g. malabsorption syndrome) or predispose a subject to GI ulceration; subjects with prior Whipple procedure are eligible
Refractory gastrointestinal (GI) disease that would prevent absorption of oral agents
Patients who have liver function test (LFTs) (including total bilirubin, aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) >= twice the upper limit of normal should be evaluated by a gastrointestinal (GI) physician unless there is a clear precipitating factor (such as an azole, methotrexate, Bactrim or another drug); if the GI physician considers that HCT on protocol 2660 is contraindicated for that patient the patient will be excluded from the protocol; patients with Gilbert’s syndrome and no other known liver function abnormality and patients with reversible drug-related transaminitis do not necessarily require GI consultation and may be included on the protocol
History of previous clinically significant GI bleed in the last 6 months prior to first dose
Active gastrointestinal (GI) or intracranial hemorrhage
Currently active GI disease, or prior surgery that may affect ability to absorb oral medications
No prior GI perforation, or GI obstruction or involvement of the bowel on imaging
No known gastrointestinal (GI) pathology that would interfere with drug bioavailability
Unsuccessful closure of collateral blood flows from the hepatic artery to non-targeted organs such as the gastrointestinal (GI) tract
History of gastrointestinal (GI) surgery within the past 28 days; if > 28 days since GI surgery, must have confirmation of complete healing before initiating treatment with study drug
History of diverticulitis, rectal bleeding or other lower gastrointestinal (GI) diseases predisposing to GI complications after radiation (will be determined by radiation oncologist)
Malabsorption due to prior gastrointestinal (GI) surgery, GI disease
Subjects are willing to undergo or must have had an endoscopy of the upper and/or lower GI tract and biopsy to confirm GI GVHD.
Patients with poorly controlled bleeding from gastric antral vascular ectasia (GAVE) or other gastrointestinal (GI) sites
Known gastrointestinal (GI) disease or GI procedures that could interfere with the oral absorption or tolerance of alisertib; examples include, but are not limited to partial gastrectomy, history of small intestine surgery, and celiac disease
Major gastrointestinal (GI) disease as defined but not limited to the following: history of inflammatory bowel disease or other illness resulting in chronic diarrhea, known achlorhydria or history of GI surgery that could reduce the acidity of the stomach, acute pancreatitis or cholecystitis within 6 months prior to Baseline, or GI disease that may interfere with the absorption of orally-administered drugs.
Impairment of GI function or GI disease that could interfere with the absorption of selinexor, including obstructed GI tract and uncontrolled vomiting or diarrhea.
History of active peptic ulcer disease or major upper gastrointestinal (GI) bleed < 12 months; history of GI bleeding from the colorectal cancer primary is not an exclusion criterion
Impaired GI function or GI disease
Patients with gastrointestinal (GI) absorptive problems making it unlikely to absorb study medication or more likely to experience GI toxicities
Patient must not have prior gastrointestinal (GI) surgery or GI disease that might interfere with the absorption of terameprocol
Impaired GI function or GI disease that may interfere with absorption of AZD8835 or patients unable to take oral medication
Recurrent nausea and/or vomiting within 14 days before the first dose of alisertib or known gastrointestinal (GI) abnormality or GI procedure that could interfere with or modify the oral absorption or tolerance of alisertib. Examples include, but are not limited to, disease-related bowel obstruction, pancreatic insufficiency, use of pancreatic enzymes, a gastric condition (such as severe reflux or active peptic ulcer disease) that requires chronic and uninterrupted use of proton pump inhibitors, partial gastrectomy, history of small intestine surgery, and celiac disease.
Known active gastrointestinal (GI) bleeding.
Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the investigator may interfere with oral drug absorption
History of gastrointestinal (GI) hemorrhage
Clinically significant gastrointestinal (GI) abnormalities that may increase the risk for GI bleeding.
Presence of active gastrointestinal (GI) disease (including GI bleeding or ulceration) or other condition that could affect GI absorption) (e.g. malabsorption syndrome, history of biliary tract disease)
PATIENT: Diagnosis of lung or gastrointestinal (GI) (colorectal, pancreas, liver) cancers
No grade 3 or 4 gastrointestinal (GI) toxicity at time of initial screening
Patients with irritable bowel syndrome, Crohn's disease, or other clinically significant gastrointestinal (GI) related condition that might confound the VEGF-TKI-related-diarrhea endpoint
Participants who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from gastrointestinal (GI) adverse events due to induction therapy; patients who have had localized radiation which would not result in any GI effects are allowed on study
Participant must have a lung or gastrointestinal (GI) primary cancer diagnosed in the last 3 months
History of clinically-significant gastrointestinal (GI) disease; GI perforation within 1 year; GI bleeding or acute pancreatitis within 3 months; or diverticulitis within 4 weeks of first study drug administration
Medical contraindications to undergoing endoscopy or obstruction of the gastrointestinal (GI) tract that precludes passage of the endoscope
History of GI ulcers, chronic GERD, or GI bleeding in the past 5 years
Patients with a diverting ileostomy, with a history of inflammatory bowel disease, familial adenomatous polyposis (FAP), or active gastrointestinal (GI) symptoms (gastrointestinal bleed, diarrhea, severe abdominal pain, etc.)
Acute gastrointestinal (GI) bleeding
Currently active gastrointestinal (GI) disease, or prior surgery that may affect ability to absorb oral medications
Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the investigator may interfere with oral drug absorption
Patients must not have malabsorption, swallowing difficulty, or other conditions that would interfere with the ingestion or absorption of dabrafenib or trametinib
Difficulty with swallowing or an active malabsorption syndrome.
Difficulty swallowing capsules or requirement for a feeding tube.
Known history of difficulty swallowing, malabsorption or other conditions that may reduce absorption of the product.
Difficulty swallowing, malabsorption, known active partial or complete bowel obstruction, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of capecitabine
Patient is capable of swallowing pills whole
Patient must be capable of swallowing the ruxolitinib capsules (tablets)
Patient is capable of swallowing pills whole
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
Previous history of difficulty swallowing capsules.
Be capable of swallowing study agents whole as a tablet
Pre-treatment swallowing evaluation by speech and swallowing therapist, to included a modified barium swallow showing no significant impairment with swallowing oral medications
History of difficulty swallowing, malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the IMP, use of percutaneous endoscopic gastrostomy (PEG) tubes
History of difficulty swallowing, malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the IMP
Difficulty swallowing or malabsorption
History of significant difficulty swallowing, malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the tested product
Relapsed/refractory MCL: Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty
Newly diagnosed MCL: Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty
Difficulty with swallowing, or an active malabsorption syndrome.
Difficulty with swallowing or an active malabsorption syndrome
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty.
History of difficulty swallowing, malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the investigational product
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
Difficulty swallowing capsules.
All subjects must be capable of swallowing multiple capsules
Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty
Patient is capable of swallowing study drug capsules whole.
Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty
Capable of swallowing tablets
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
Patient is capable of swallowing.
Known gastrointestinal disease or condition that affects the absorption of ASN001, or difficulty swallowing large capsules.
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
Subject has difficulty swallowing large pills.
The subject has difficulty swallowing, malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the trial drug. Subjects requiring total parenteral nutrition are to be excluded.
Has difficulty swallowing medications, or known history of malabsorption syndrome;
Capable of swallowing intact study medication capsules
Active difficulty swallowing, malabsorption or other chronic gastrointestinal disease or conditions (including pancreas deficiency requiring Creon therapy) that may hamper compliance and/or absorption of M3541