Participants may not have had history of abdominal fistula or gastrointestinal perforation within the past 6 months
Participants may not have had a history of intra-abdominal abscess within the past 6 months
History of abdominal fistula, gastrointestinal perforation, peptic ulcer, or intra-abdominal abscess within 6 months
History of abdominal fistula, intra-abdominal abscess, or gastrointestinal perforation within the last 3 months
No gastrointestinal disorders associated with a high risk of perforation or fistula formation within 6 months prior to registration:\r\n* Abdominal fistula\r\n* Gastrointestinal perforation\r\n* Intra-abdominal abscess; Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months prior to registration
History of abdominal/pelvic or tracheoesophageal fistula or gastrointestinal perforation and/or abscess within 6 months prior to initiation of treatment
Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:\r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesions\r\n* Inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease) or other gastrointestinal conditions which increase the risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to beginning study treatment
Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment are NOT eligible for participation
Clinically significant gastrointestinal (GI) abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:\r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesion/s with risk of bleeding\r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation \r\n* History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment\r\n* Clinically significant (> 1/2 teaspoon) hemoptysis or gastrointestinal hemorrhage in the past 6 months
History of abdominal fistula or gastrointestinal perforation within 6 months prior to day 1
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:\r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesion/s with risk of bleeding\r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess =< 28 days prior to randomization\r\n* Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:\r\n** Malabsorption syndrome\r\n** Any prior major resection of the stomach or small bowel
History of abdominal fistula, gastrointestinal perforation, pneumothorax, or intra-abdominal abscess within 28 days of study enrollment
History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, clinical signs or symptoms of gastrointestinaI obstruction or other known clinically signification gastrointestinal disease.
Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug
No history of abdominal fistula, gastrointestinal (GI) perforation, intra abdominal abscess, uncontrolled GI bleeding, diverticulitis within 6 months of study entry
Patients with a history of abdominal or tracheal-esophageal fistula, or gastrointestinal perforation are not eligible; patients with a history of intra-abdominal abscess within 6 months of enrollment
Active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
history of abdominal fistula or gastrointestinal perforation
intra-abdominal abscess within last 3 months prior to the first dose of study drug
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study enrollment.
Patients who have a history of fistula, gastrointestinal ulcer or perforation, or intra-abdominal abscess within 3 months of study enrollment are not eligible
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization.
Active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
History of abdominal fistula or gastrointestinal perforation within 6 months prior to registration
History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to starting treatment
History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 1
Has a known history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to planned start of study drug
Any history of gastrointestinal (GI) perforation, history of intra-abdominal abscess within 3 months prior to starting treatment, or history of abdominal fistula unless the fistula history meets all the following: (a) the fistula was surgically repaired, (b) there has been no evidence of fistula for at least 6 months prior to starting treatment, (c) patient is deemed to be at low risk of recurrent fistula, and (d) the case must be discussed with the study PI
Any of the following within 6 months before the first dose of study treatment: abdominal fistula, gastrointestinal perforation, bowel obstruction or gastric outlet obstruction, intra-abdominal abscess. Note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months before the first dose of study treatment. Other disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement within 90 days before the first dose of study therapy.
Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for tumor resection
Any of the following within 2 months of registration: active peptic ulcer disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, malabsorption syndrome; any of the following within 6 months of registration: intra-abdominal abscess, gastrointestinal obstruction requiring parenteral hydration and/or nutrition, gastrointestinal perforation; note: complete resolution of an intra-abdominal abscess must be confirmed prior to registration even if the abscess occurred more than 6 months prior to registration
History of abdominal or tracheoesophageal fistula or gastrointestinal perforation within 6 months prior to enrollment
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:\r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesion(s) with risk of bleeding\r\n* Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions with increased risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
Active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment; gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed
History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 28 days prior to registration.
Any of the following within 6 months before the first dose of study treatment:\r\n* Abdominal fistula\r\n* Gastrointestinal perforation\r\n* Bowel obstruction or gastric outlet obstruction\r\n* Intra-abdominal abscess; Note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months before the first dose of study treatment
History of abdominal or tracheoesophageal fistula or gastrointestinal (GI) perforation within 6 months of first study treatment
History of abdominal fistula, intra-abdominal abscess, or gastrointestinal perforation within the 3 months prior to enrollment
Any of the following conditions:\r\n* Active peptic ulcer disease\r\n* Inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease) or other gastrointestinal conditions which increase the risk of perforation\r\n* History of new abdominal fistula, gastrointestinal perforation or intra-abdominal abscess =< 84 days prior to registration; NOTE: enrollment of patients with chronic/canalized fistulous tracts (present for > 84 days) is allowed\r\n* Serious or non-healing wound, ulcer, or bone fracture\r\n* History of familial QTc prolongation syndrome
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess =< 6 months prior to registration
Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug
History of abdominal or tracheoesophageal fistula or gastrointestinal perforation within 6 months prior to cycle 1, day 1
Active inflammatory gastrointestinal disease such as chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment; gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed
Previous history of abdominal fistula, tracheoesophageal fistula or other fistula with grade 4 severity, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to enrollment
Any of the following within 28 days of first date of study treatment: \r\n* Serious uncontrolled medical illness or disorder that in the opinion of the treating physician would make the patient ineligible for the study\r\n* Active uncontrolled infection (with the exception of uncomplicated urinary tract infection) \r\n* Abdominal fistula, gastrointestinal perforation or intra-abdominal abscess\r\n* Abdominal surgery (for reasons other than IP port placement)
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nHistory of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nHistory of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula
History of intra-abdominal abscess within the past 3 months
History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within six months prior to treatment start
History of abdominal fistula or gastrointestinal perforation =< 6 months prior to treatment with study drugs
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding, including (but not limited to) active peptic ulcer disease, known intraluminal metastatic lesions with risk of bleeding, inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease) or other gastrointestinal (GI) conditions with increased risk of perforation, history of abdominal fistula or intra-abdominal abscess within 28 days prior to beginning study treatment
History of abdominal fistula or gastrointestinal perforation =< 6 months prior to treatment with study drugs
History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days or manifestations of malabsorption due to prior gastrointestinal (GI) surgery or GI disease that may alter the absorption of MLN0128 (TAK-228)
Gastrointestinal perforation or intra-abdominal abscess (< 3 months); recent (< 3 months) gastrointestinal (GI) bleeding from gastric or duodenal ulcer
History of abdominal fistula or gastrointestinal perforation within 6 months prior to day 1
Patients with peptic ulcer, abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 6 months of registration
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 0
History of abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months of randomization
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: \r\n* Active peptic ulcer disease \r\n* Known intraluminal metastatic lesion/s with risk of bleeding \r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn‘s disease), or other gastrointestinal conditions with increased risk of perforation \r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 1
History of abdominal fistula or gastrointestinal perforation within 6 months prior to day 1 of FOLFIRI + bevacizumab initiation
History of an abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within previous 6 months
History of abdominal fistula or gastrointestinal perforation within 6 months prior to randomization
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1 of study drug
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:\r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesion/s with risk of bleeding\r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess =< 28 days prior to registration\r\n* Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:\r\n** Malabsorption syndrome\r\n** Major resection of the stomach or small bowel
History of gastrointestinal perforation, abscess or fistula
History of abdominal fistula formation, gastrointestinal perforation, or abdominal abscess within six months
Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\r\n* Any of the following within 28 days before the first dose of study treatment\r\n** Intra-abdominal tumor/metastases invading GI mucosa\r\n** Active peptic ulcer disease,\r\n** Inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis\r\n** Malabsorption syndrome\r\n* Any of the following within 6 months before the first dose of study treatment:\r\n** Abdominal fistula\r\n** Gastrointestinal perforation\r\n** Bowel obstruction or gastric outlet obstruction\r\n** Intra-abdominal abscess; note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months before the first dose of study treatment
Patients with clinically significant gastrointestinal abnormalities including, but not limited to:\r\n* Clinically significant signs and/or symptoms of bowel obstruction within 3 months prior to starting treatment\r\n* History of intra-abdominal abscess within 3 months prior to starting treatment\r\n* History of gastrointestinal (GI) perforation within 6 months prior to starting treatment\r\n* Evidence of abdominal fistula within 6 months prior to starting treatment; history of abdominal fistula will be considered eligible if the fistula was surgically repaired, and there has been no evidence of fistula for at least 6 months prior to starting treatment, and patient is deemed to be at low risk of recurrent fistula
History of intra-abdominal abscess within the past 3 months
History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula
History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\r\n* Any of the following at the time of screening\r\n** Intra-abdominal tumor/metastases invading gastrointestinal (GI) mucosa\r\n** Active peptic ulcer disease\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 before the first dose of study treatment; history of abdominal fistula; gastrointestinal perforation; bowel obstruction or gastric outlet obstruction; intra-abdominal abscess; Note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months ago\r\n* 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
No evidence of a bowel obstruction, abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of study entry
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess in previous 6 months
Patients who have a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study enrollment are not eligible
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1
Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including\r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesions\r\n* Inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease) or other gastrointestinal conditions which increase the risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to beginning study treatment
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1 of treatment
Patients with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:\r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesions\r\n* Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
Patients must not have a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study entry
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
History of abdominal fistula or gastrointestinal perforation at any point within 6 months prior to day 1 of study drug, unless surgically repaired
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 prior to the first date of study treatment; Note: Deliberate surgically created abdominal fistula is acceptable
Patient must have no history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to randomization
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:\r\n* Active peptic ulcer disease\r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding, including (but not limited to) active peptic ulcer disease, known intraluminal metastatic lesions with risk of bleeding, inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease) or other gastrointestinal (GI) conditions with increased risk of perforation, history of abdominal fistula or intra-abdominal abscess within 28 days prior to beginning study treatment
No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within past 12 months
Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other Gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, GI perforation, or intra-abdominal abscess within 4 weeks before beginning study treatment
Patients are excluded if they have history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization
History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to Day 1.
History of abdominal or tracheoesophageal fistula or gastrointestinal perforation within 6 months prior to cycle 1, day 1
Any of the following within 2 months of registration: active peptic ulcer disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, malabsorption syndrome; any of the following within 6 months of registration: intra-abdominal abscess, gastrointestinal obstruction requiring parenteral hydration and/or nutrition, gastrointestinal perforation; Note: complete resolution of an intra-abdominal abscess must be confirmed prior to registration even if the abscess occurred more than 6 months prior to registration
Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for tumor resection
History of abdominal fistula or gastrointestinal perforation at any point within 6 months prior to day 1 of study drug, unless surgically repaired
Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for tumor resection
Patients with a history of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to Day 0
Patients with a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months prior to registration are not eligible
History of intra-abdominal abscess within 3 months prior to starting treatment
History of GI perforation. Patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired, there has been no evidence of fistula for at least 6 months prior to starting treatment, and patient is deemed to be at low risk of recurrent fistula
History of abdominal/pelvic fistula, gastrointestinal perforation and/or intraabdominal abscess within 6 months prior to day 1
History of abdominal or other significant fistula, gastrointestinal or other organ perforation; Note: if the affected area was surgically resected, and there is no further risk to the area, patients may enroll
Participants may not have had history of abdominal fistula or gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula has healed or was surgically repaired, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula
Participants may not have had a history of intra-abdominal abscess within the past 3 months
Has a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to start of study drug
Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\r\n*Any of the following within 28 days before the first dose of study treatment:\r\n** Intra-abdominal tumor/metastases invading gastro-intestinal mucosa\r\n** Active peptic ulcer disease\r\n** Inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis\r\n** Malabsorption syndrome\r\n* Any of the following within 6 months before the first dose of study treatment:\r\n** Abdominal fistula\r\n** Gastrointestinal perforation\r\n** Bowel obstruction or gastric outlet obstruction\r\n** Intra-abdominal abscess; Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months before the first dose of study treatment
History of abdominal fistula, gastrointestinal perforation, peptic ulcer, or intra-abdominal abscess within 6 months
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:\r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesion/s with risk of bleeding\r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: \r\n* Active peptic ulcer disease \r\n* Known intraluminal metastatic lesion/s with risk of bleeding \r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation \r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the previous 6 months are not eligible for participation
Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug
No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to registration
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: active peptic ulcer disease, known intraluminal metastatic lesion/s with risk of bleeding, Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 1
Patient must not have any clinically significant gastrointestinal abnormality that may increase the risk of gastrointestinal (GI) bleeding including, but not limited to, active peptic ulcer disease, known intraluminal metastatic lesions with risk of bleeding, inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease), other GI conditions with increased risk of perforation, history of abdominal fistula or GI perforation or intra-abdominal abscess within 28 days prior to beginning study treatment
No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:\r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesion/s with risk of bleeding\r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation \r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to registration
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:\r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesion/s with risk of bleeding\r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess =< 6 months prior to randomization
History of abdominal fistula or gastrointestinal perforation within 6 months prior to day 1
History of abdominal fistula or gastrointestinal perforation within 6 months prior to day -3
Clinically significant gastrointestinal abnormalities which might interfere with oral dosing, including, but not limited to:\r\n* Malabsorption syndrome\r\n* Major resection of the stomach or small bowel that could affect the absorption of study drug\r\n* Inflammatory bowel disease\r\n* Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including\r\n* Active peptic ulcer disease, not on a proton pump inhibitor\r\n* Known intraluminal metastatic lesions\r\n* Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or \r\n* Other gastrointestinal conditions which increase the risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to beginning study treatment
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: \r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesion/s with risk of bleeding\r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study registration
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:\r\n* Active peptic ulcer disease\r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment\r\n* Clinically significant hemoptysis or gastrointestinal hemorrhage in the past 6 months
Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to planned day 1 of dosing are ineligible
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study entry
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal (GI) bleeding including, but not limited to: \r\n* Active peptic ulcer disease; \r\n* Known intraluminal metastatic lesion/s with suspected bleeding; \r\n* Inflammatory bowel disease; \r\n* Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation; \r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
Subjects with a History of bowel obstruction, including sub?occlusive disease, related to the underlying\r\ndisease and history of abdominal fistula, gastrointestinal perforation or intra?abdominal abscess
History of gastrointestinal perforation, abdominal fistula or intra-abdominal abscess within 6 months of enrollment.
History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
History of abdominal fistula or gastrointestinal perforation =< 6 months prior to treatment with study drugs
History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\r\n* Any of the following that have not resolved within 28 days before the first dose of study treatment\r\n** Intra-abdominal tumor/metastases invading GI mucosa\r\n** Active peptic ulcer disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis\r\n** Malabsorption syndrome\r\n* Any of the following within 6 months before the first dose of study treatment:\r\n** Abdominal fistula\r\n** Gastrointestinal perforation\r\n** Bowel obstruction or gastric outlet obstruction\r\n** Intra-abdominal abscess; Note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months before the first dose of study treatment
Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\r\n* Any of the following at the time of screening\r\n** Intra-abdominal tumor/metastases invading gastrointestinal (GI) mucosa\r\n** Active peptic ulcer disease\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 before the first dose of study treatment:\r\n** History of abdominal fistula\r\n** Gastrointestinal perforation\r\n** Bowel obstruction or gastric outlet obstruction\r\n** Intra-abdominal abscess; Note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months ago\r\n** Malabsorption syndrome\r\n* Percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months before the first dose of study therapy
Abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months
History of abdominal or tracheo-oesophageal fistula or gastrointestinal (GI) perforation or intra abdominal abscess within 6 months prior to Day 1 of Cycle 1
History of abdominal fistula or gastrointestinal perforation
Patients with an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
Conditions likely to increase the potential for abdominal perforation or fistula formation, including but not limited to: Luminal intestinal cancers or bulky abdominal disease. Presence or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease or intra-abdominal abscess within the six months prior to the first dose of GSK3052230. Other risk factors for perforation, such as acute diverticulitis, obstruction or previous abdominal or pelvic radiation.
Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\r\n* Any of the following at the time of screening:\r\n** Intra-abdominal tumor/metastases invading gastrointestinal (GI) mucosa\r\n** Active peptic ulcer disease\r\n** Inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis\r\n** Malabsorption syndrome\r\n* Any of the following within 6 months before the first dose of study treatment:\r\n** History of abdominal fistula\r\n** Gastrointestinal perforation\r\n** Bowel obstruction or gastric outlet obstruction\r\n** Intra-abdominal abscess; Note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months ago
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess =< 6 months prior to registration
Active peptic ulcer disease or history of abdominal fistula, GI perforation, or intra abdominal abscess within 28 days prior to enrolment
Evidence of abdominal fistula, gastrointestinal (GI) perforation or intraabdominal abscess
Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\r\n* Any of the following within 28 days before the first dose of study treatment\r\n** Intra-abdominal tumor/metastases invading gastrointestinal (GI) mucosa (malignant abdominal ascites does not constitute mucosal invasion)\r\n** Active peptic ulcer disease\r\n** Inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis\r\n** Malabsorption syndrome\r\n* Any of the following within 6 months before the first dose of study treatment:\r\n** History of abdominal fistula\r\n** Gastrointestinal perforation\r\n** Bowel obstruction or gastric outlet obstruction\r\n** Intra-abdominal abscess; Note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months ago
Patients with any of the following conditions are excluded: serious or non-healing wound, ulcer; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment; coronary/peripheral artery bypass graft or stenting within the past 12 months; or cerebrovascular accident (CVA) or transient ischemic attack within the past 12 months
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment
Clinically significant gastrointestinal abnormalities including, but not limited to:\r\n* Malabsorption syndrome\r\n* Major resection of the stomach or small bowel that could affect the absorption of study drug\r\n* Active peptic ulcer disease\r\n* Inflammatory bowel disease\r\n* Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 0
History of an abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within previous 6 months
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: active peptic ulcer disease; known intraluminal metastatic lesion/s with risk of bleeding; inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to registration
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study screening
No history of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within past 12 months
History of abdominal or tracheoesophageal fistula or gastrointestinal (GI) perforation within 6 months of first study treatment
History of abdominal fistula or gastrointestinal perforation within 6 months prior to day 1
History of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to Day 1
History of abdominal or tracheoesophageal fistula or gastrointestinal (GI) perforation within 6 months of first study treatment
Patients must not have known contraindications to bevacizumab, including but not limited to abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess, thrombotic or hemorrhagic disorders, uncontrolled hypertension or active clinically significant cardiovascular disease, non-healing wound, ulcer, or bone fracture within previous 4 weeks
Patients must not have clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:\r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesion/s with risk of bleeding \r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
Patient must not have a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess =< 6 months prior to study entry