History of known risks factors for bowel perforation
Acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction within the past 6 months.
Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: Tumors invading the GI tract, active peptic ulcer disease, inflammatory bowel disease, (eg, Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction, abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess within 6 months before randomization
Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, or abdominal carcinomatosis (known risks factors for bowel perforation)
Patients who have had a history of acute diverticulitis, abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis which are known risks factors for bowel perforation, should be excluded from the study
The subject has experienced any of the following:\r\n* Clinically-significant GI bleeding within 6 months before the first dose of study treatment;\r\n* Gastrointestinal (GI) disorders particularly those associated with a high risk of perforation or fistula formation including:\r\n** Tumors invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (eg, Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction\r\n** Abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess within 6 months before randomization,\r\n** Note: complete healing of an intra-abdominal abscess must be confirmed prior to randomization\r\n* Hemoptysis of >= 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of study treatment;\r\n* Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment\r\n* Patient who have developed or have had history of pulmonary hemorrhage while on carfilzomib will be excluded (fatal pulmonary hemorrhage has been observed with carfilzomib)
History of acute diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation.
Active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation.
Patients with risk factors for bowel obstruction or bowel perforation (e.g., acute diverticulitis) will be excluded
Patients who have had a history of illness which put them at current risk for bowel perforation such as acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis
History of acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation
Active gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation; subjects with enteric stomata (such as ileostomy, colostomy) are also excluded:\r\n* Tumors invading the GI-tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction\r\n* Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intraabdominal abscess within 12 weeks before enrollment; NOTE: complete healing of an intra-abdominal abscess must be confirmed before enrollment
Active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation
Patients who have had a history of acute diverticulitis, abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis which are known risks factors for bowel perforation, should be excluded from the study
History of acute diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation.
Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.
Subjects who have had a history of acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation.
The following are additional exclusion criteria for patients enrolling in expansion cohort C:\r\n* Uncontrolled blood pressure (> 140/90); patients should have a blood pressure of =< 140/90 taken by a medical professional within one week of starting on study\r\n* Proteinuria > 2+ on urinalysis\r\n* Serosal involvement of the bowel that would render the patient at increased risk of gastrointestinal perforation\r\n* Other gastrointestinal orders that could increase the potential risk of perforation or fistula formation, including but not limited to the following:\r\n** Intra-abdominal metastases/tumor invading the gastrointestinal (GI) mucosa\r\n** Active peptic ulcer disease within 28 days of registration\r\n** Inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis, or appendicitis\r\n* Any of the following within 6 months of registration:\r\n** Abdominal fistula\r\n** Gastrointestinal perforation\r\n** Bowel obstruction or gastric outlet obstruction\r\n** Note: patients requiring drainage gastrostomy (e.g., PEG tube) and/or parenteral hydration and/or nutrition are not eligible\r\n** Intraabdominal abscess\r\n** Note: complete resolution of an intraabdominal abscess must be confirmed prior to registration even if the abscess occurred more than 6 months prior to registration\r\n* Major surgery within 3 months of the first dose of study drugs if there were no wound healing complications or within 6 months of the first dose of study drugs if there were wound complications
Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, abdominal/pelvic fistula, gastrointestinal perforation, gastrointestinal (GI) obstruction and/or who require parenteral hydration and/or nutrition
Patients must not have an acute or subacute intestinal obstruction; no history of bowel obstruction, gastrointestinal (GI) perforation, major abdominal surgery with bowel resection, or perirectal/perianal abscess within 6 months prior to randomization
Subjects with a history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess; clinical signs or symptoms of GI obstruction and/or requirement for parenteral hydration or nutrition. In addition, subjects with other known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease.
Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, or abdominal carcinomatosis (known risks factors for bowel perforation)
History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess; evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction
Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, or abdominal carcinomatosis (known risks factors for bowel perforation)
Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, or abdominal carcinomatosis (known risks factors for bowel perforation)
History of known risks factors for bowel perforation
Participants may not have evidence of a bowel obstruction, abdominal fistula, or intra-abdominal abscess within 6 months of study entry; participants with current signs or symptoms suggestive of bowel obstruction including early or partial obstruction are ineligible; participants with a history of gastrointestinal perforation at any time point are ineligible
Patient has risk factors for bowel obstruction or bowel perforation (examples include but not limited to a history of acute diverticulitis, intra-abdominal abscess, and abdominal carcinomatosis)
Patients who have had a history of acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation
Patients with the risk factors for bowel obstruction or bowel perforation (examples include but not limited to a history of acute diverticulitis, intra-abdominal abscess, abdominal carcinomatosis).
History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess; evidence of recto sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction
Patients with symptoms of partial or complete bowel obstruction and recent (within 6 month) history of fistula, intra-abdominal abscess or bowel perforation
History of abdominal fistula, gastrointestinal perforation, bowel obstruction, gastric outlet obstruction, or intra-abdominal abscess within six months of study enrollment
Ongoing bowel perforation or presence of bowel fistula or abscess within 3 months of registration
Patients who have intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation
Patients who have had a history of acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation
History of bowel obstruction, including sub-occlusive disease, related to the underlying disease or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscesses. Evidence of rectosigmoid involvement by pelvic examination or bowel involvement on computed tomography (CT) scan or clinical symptoms of bowel obstruction.
Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction - Receipt of any live vaccine within 4 weeks.