Gastrointestinal perforation or fistula in the 6 months prior to randomization unless underlying risk has been resolved (e.g., through surgical resection or repair)
History of gastrointestinal perforation and/or fistulae within 6 months prior to initiation of study treatment;
History of gastrointestinal perforation within last 6 months.
History of gastrointestinal perforation and/or fistulae within 6 months prior to enrollment
No history of gastrointestinal fistula or gastrointestinal perforation < 90 days of registration
History of upper GI bleeding, ulceration or perforation within 6 months before the first dose of defactinib.
At risk of bowel perforation
No myocardial infarction, gastrointestinal (GI) perforation/fistula, intraabdominal abscess, cerebrovascular accidents within six months prior to study entry
Prior history of gastrointestinal diverticulitis, perforation, or abscess.
History of prior gastrointestinal fistula and/or perforation
History of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years; patients with ulceration, bleeding or perforation in the lower bowel are not excluded
History of gastrointestinal perforation or fistula in the 6 months prior to study treatment, or while previously on antiangiogenic therapy, unless underlying risk has been resolved (e.g., through surgical resection or repair)
The patient has a history of GI perforation and/or fistulae within 6 months prior to enrollment
History of clinically significant gastrointestinal bleeding, colitis, or gastrointestinal perforation.
History of gastrointestinal perforation or fistula in the past 6 months, or while previously on antiangiogenic therapy, unless underlying risk has been resolved (e.g., through surgical resection or repair)
Gastrointestinal (GI) perforation/fistula
History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization
Subjects with evidence of bladder perforation during diagnostic cystoscopy may be treated if perforation has resolved prior to dosing.
Has a history of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years; subjects with ulceration, bleeding or perforation in the lower bowel are not excluded
Clinically-significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis.
Patients at significant risk for GI perforation or fistula
The participant has a history of gastrointestinal perforation or fistula within 6 months.
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 gastrointestinal intraluminal metastatic lesions (gastrointestinal serosa metastatic lesions are permitted)\r\n* Inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease) or other gastrointestinal conditions with increased risk of perforation\r\n* Patients with clinical symptoms or signs of gastrointestinal obstruction and patients who require parenteral hydration and/or nutrition
Patients may not have a prior history of GI perforation/fistula (within 6 months of first dose of protocol therapy) or risk factors of perforation
History of gastrointestinal perforation or fistula in the past 6 months, or while previously on antiangiogenic therapy, unless underlying risk has been resolved (e.g., through surgical resection or repair)
No history of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years; patients with ulceration, bleeding or perforation in the lower bowel are NOT excluded
History of gastrointestinal perforation or fistula in the past 6 months, or while previously on antiangiogenic therapy, unless underlying risk has been resolved (e.g., through surgical resection or repair)
have a history of GI perforation and/or fistulae within 6 months prior to enrollment
Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
History of clinically-significant cardiovascular disease; gastrointestinal perforation; gastrointestinal bleeding, acute pancreatitis or diverticulitis within 4 weeks of first study drug administration
Have a history of gastrointestinal perforation and/or fistula within 6 months prior to enrollment.
The participant has a history of gastrointestinal perforation or fistula within 6 months prior to randomization.
History of gastrointestinal perforation =< 12 months prior to randomization
The patient has significant bleeding disorders or vasculitis; history of significant (in the opinion of the investigator) upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years; patients with a history of ulceration, bleeding or perforation in the lower bowel are not excluded
Patients will be excluded if they have had a major resection of the bowel that could influence absorption, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation within 28 days prior to beginning study treatment
History of upper gastrointestinal bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug
Prior history of bowel perforation
History of gastrointestinal (GI) perforation within 5 years or patient has a current or prior intestinal fistula
History of upper gastrointestinal bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug.
History of upper gastrointestinal bleeding, ulceration, or perforation within 6 months prior to the first dose of protocol therapy
History of gastrointestinal perforation and/or fistulae within 6 months prior to course 1 day 1 (C1D1)
3. History of upper GI bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug.
History of upper gastrointestinal bleeding, ulceration, or perforation within 12 months.
Have a history of GI perforation and/or fistulae within 6 months prior to receiving study drugs.
History of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years; patients with ulceration, bleeding or perforation in the lower bowel are not excluded
History of prior gastrointestinal perforation
History of complicated diverticulitis, including fistulae, abscess formation or gastrointestinal (GI) perforation
No history of gastrointestinal obstruction, or conditions that increase the risk of gastrointestinal obstruction, perforation, bleeding or impairment of the gastrointestinal wall; no abdominal surgery within 60 days of registration
History of a gastrointestinal perforation
Gastrointestinal perforation or fistulae within 6 months prior to randomization.
Individuals with any history of transfusion-dependent gastrointestinal bleeding, gastrointestinal perforation or gastrointestinal obstruction; if any of these events had been due to a malignancy of the GI tract and the malignancy has since been removed, the patient is eligible
Patients with active gastrointestinal disorders, those requiring procedures that pre-dispose to gastrointestinal (GI) perforation, those with a history of transmural inflammatory conditions, and/or history of gastrointestinal ulcers, strictures, obstructions, fistulae, and/or abscess will be excluded from the study due to the risk of serious and sometimes fatal gastrointestinal perforation
Patients at risk for GI perforation.
History of gastrointestinal perforation or fistula in the past 6 months, or while previously on antiangiogenic therapy, unless underlying risk has been resolved
Clinically-significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis (Parts D and E only).