No gastrointestinal disorders associated with a high risk of perforation or fistula formation within 3 months prior to registration:\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* Known malabsorption syndrome\r\n* Bowel obstruction or gastric outlet obstruction\r\n* Percutaneous endoscopic gastrostomy (PEG) tube placement
Active small or large intestine inflammation such as Crohn’s disease or ulcerative colitis
Patients with clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding are NOT eligible for participation; these may include (but are 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)\r\n* Other gastrointestinal conditions with increased risk of perforation
History of symptomatic autoimmune disease (such as lupus, scleroderma, Crohn’s disease, ulcerative colitis) requiring systemic treatment (for example corticosteroids or immunosuppressants); replacement therapy (for example, thyroxine, insulin) is not considered a systemic treatment
The patient has serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn’s disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)
Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn’s disease, ulcerative colitis, or chronic diarrhea
Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn’s disease, ulcerative colitis, chronic diarrhea, malabsorption)
Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn’s disease, ulcerative colitis, chronic diarrhea, malabsorption)
Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn’s disease, ulcerative colitis, chronic diarrhea, malabsorption)
Inability to swallow oral medication; or the presence of a poorly controlled gastrointestinal disorder that could significantly affect the absorption of oral study drug – e.g. Crohn’s disease, ulcerative colitis, chronic diarrhea (defined as > 4 loose stools per day), malabsorption, or bowel obstruction.
Active rectal diverticulitis, Crohn’s disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn’s disease not affecting the rectum are allowed)
History of active autoimmune diseases such as but not limited to Crohn’s disease, ulcerative colitis, Sjogren’s syndrome, requiring active immune suppression; patient may have hay fever or controlled asthma
Patients with a history of colitis.
Patient is unable to take drugs orally due to disorders or diseases that may affect gastrointestinal function, such as inflammatory bowel diseases (eg, Crohn’s disease, ulcerative colitis) or malabsorption syndrome, or procedures that may affect gastrointestinal function, such as gastrectomy, enterectomy, or colectomy
History of clinically severe (e.g., requires chronic immunosuppressive therapy, [e.g., cyclosporine A, tacrolimus]) autoimmune disease (e.g., ulcerative colitis, lupus), or history of organ transplant
Any of the following within 28 days before the first dose of study treatment\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
Grade 3 or higher colitis attributable to PD1 blockade; note that colitis attributable to ipilimumab is not excluded
Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn’s disease, ulcerative colitis, chronic diarrhea, malabsorption)
Gastrointestinal tract disease or defect or previous history of colitis.
Has evidence of colitis
History of Crohn’s disease or ulcerative colitis
Has chronic, active colitis
CAPMATINIB EXCLUSION CRITERIA: Gastrointestinal disease (e.g., Crohn’s disease, ulcerative colitis, short gut syndrome) or other malabsorption syndromes that would impact on drug absorption
CERITINIB EXCLUSION CRITERIA: Gastrointestinal disease (e.g., Crohn’s disease, ulcerative colitis, short gut syndrome) or other malabsorption syndromes that would impact on drug absorption
REGORAFENIB EXCLUSION CRITERIA: Gastrointestinal disease (e.g., Crohn’s disease, ulcerative colitis, short gut syndrome) or other malabsorption syndromes that would impact on drug absorption
ENTRECTINIB EXCLUSION CRITERIA: Gastrointestinal disease (e.g., Crohn’s disease, ulcerative colitis, short gut syndrome) or other malabsorption syndromes that would impact on drug absorption
History or presence of digestive tract diseases, including active gastric/duodenal ulcer or ulcerative colitis, or active hemorrhage of an unresected gastrointestinal tumor, or an evaluation by investigators of having any other condition that could possibly result in gastrointestinal tract hemorrhage or perforation;
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basis
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basis
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn`s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basis
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basis
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basis
History of inflammatory colitis or other active severe comorbidities
The presence of poorly controlled gastrointestinal disorders that could affect the absorption of the afatinib (e.g. Crohn‘s disease, ulcerative colitis, chronic diarrhea, malabsorption)
History of Crohn’s disease or Ulcerative colitis
Any active gastrointestinal (GI) impairment which, in the opinion of the investigator, would impair or alter the absorption of ceritinib (e.g., ulcerative colitis, or Crohn’s disease)
History of (H/o) Crohn’s disease/ulcerative colitis/scleroderma
Active rectal diverticulitis, Crohn’s disease, or ulcerative colitis
Any patient with active Crohn’s disease or active ulcerative colitis
Pre-existing Familial adenomatous polyposis, inflammatory bowel disease or ulcerative colitis
History of Crohn’s disease, ulcerative colitis, or ataxia telangiectasia
Chronic diarrhea > grade 1, or a diagnosis of Crohn’s or ulcerative colitis
History of diverticulitis, diverticulosis requiring antibiotic treatment or chronic ulcerative lower gastrointestinal (GI) disease such as Crohn’s disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations
Patients must not have active or a history of small or large intestine inflammation such as Crohn’s disease or ulcerative colitis
Active peptic ulcer disease, inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), diverticulitis or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding
Intraluminal metastatic lesion with suspected bleeding, inflammatory bowel disease, ulcerative colitis or other GI condition associated with increased risk of perforation
Active peptic ulcer disease, inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding
History of diverticulitis, chronic ulcerative lower GI disease such as Crohn’s disease or ulcerative colitis, or other symptomatic lower GI conditions that might predispose to perforations
History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (for example, Crohn’s disease, ulcerative colitis); patients requiring feeding tubes are permitted
No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 28 days prior to registration including, but not limited to: \r\n* Active peptic ulcer\r\n* Known endoluminal metastatic lesion(s) with history of bleeding\r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation
At the time of screening, active peptic ulcer disease or active inflammatory bowel disease (including ulcerative colitis or Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis, or appendicitis
Malabsorption syndrome, (prior surgical procedures affecting absorption), or inflammatory gastrointestinal (GI) disease (e.g., Crohn’s, ulcerative colitis) which in the opinion of the study coordinator is likely to limit normal absorption of the drug
Patients with Crohn’s disease or ulcerative colitis
History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (eg, Crohn’s disease, ulcerative colitis); patients requiring feeding tubes are permitted
History of Crohn’s disease or ulcerative colitis
Significant gastrointestinal disorder(s), in the opinion of the principal investigator (e.g., Crohn’s disease, ulcerative colitis, extensive gastric resection)
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding (e.g. active peptic ulcer, ulcerative colitis, Crohn’s disease, abdominal fistula) within prior 6 months
No clinically significant gastrointestinal abnormalities that may increase the risk of gastrointestinal bleeding within 28 days prior to registration including, but not limited to:\r\n* Active peptic ulcer\r\n* Known endoluminal metastatic lesion(s) with history of bleeding\r\n* Active inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s Disease), or other gastrointestinal conditions with increased risk of perforation
Patients who have malabsorption problems, such as ulcerative colitis, irritable bowel syndrome, Crohn’s disease, bowel surgery such as gastric bypass, and celiac disease
History of diverticulitis, Crohn’s disease or ulcerative colitis
Have a personal history of inflammatory bowel disease (Crohn’s disease or colitis), colon polyps, or a history of cancer except non-melanoma skin cancer
Ongoing irritable bowel syndrome (IBS) or colitis (including but not limited to ulcerative colitis, Crohn’s disease, microscopic colitis, etc.)
Patients who are treated for a medical condition (such as ulcerative colitis) with chronic steroids during the 2 years prior to planned mastectomy surgery
Patient has a history of severe GI tract insult including but not limited to previous bowel perforation, grade 4 neutropenic colitis or typhlitis, inflammatory bowel syndrome, short small bowel syndrome (Crohn’s disease, ulcerative colitis) or history of bowel resection
Patients with ulcerative colitis in clinical remission (UCDAI) =< 1 for at least 3 months, regardless of how long ago they were diagnosed for UC
Known diagnosis of colon heritable cancer syndrome (familial adenomatous polyposis [FAP], hereditary nonpolyposis colorectal cancer [HNPCC]) or inflammatory bowel disease (Crohn’s disease, ulcerative colitis)
No previous diagnoses of ulcerative colitis, Crohn’s disease or irritable bowel disease